[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"overactive-bladder-oab\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:overactive-bladder-oab":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,28,0,25,[9,48,73,101,113,132,160,180,201,239,261,287,306,332,357,386,398,419,453,478,500,528,552,575,599],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100054171","aquarius-pilot-study-to-evaluate-the-new-axonics-trial-system-100054171",false,"NCT07335484","Aquarius Pilot Study to Evaluate the New Axonics Trial System","Prospective, Multicenter, Single Arm Feasibility and Safety Study of the Axonics External Trial System (ETS-02)","Inclusion Criteria:\n\n* 18 years or older\n* Provides written informed consent prior to trial procedures\n* Primary indication of OAB (UUI\u002FUF) or chronic FI who are considered candidates for an Axonics PNE procedure as assessed by the physician per product IFU\n\nExclusion Criteria:\n\n* Any participant that the study Investigator deems to be a poor candidate for any reason, including, but not limited to, inability to complete a baseline bladder or bowel diary or to be compliant with study visits\n* Planned changes to current regimen of medications during the trial period that could impact bladder or bowel function\n* Current urinary tract mechanical obstruction (e.g., benign prostatic enlargement or urethral stricture)\n* Current symptomatic urinary tract infection (UTI)","ALL","18 Years",{"count":20,"type":21},75,"ESTIMATED","INTERVENTIONAL",[24],"NA","Evaluation of the new Axonics External Trial System (ETS-02) in patients with overactive bladder (OAB) and\u002For fecal incontinence (FI).",[27,28,29,30],"Urinary Urge Incontinence (UUI)","Urinary Frequency (UF)","Fecal Incontinence (FI)","Overactive Bladder (OAB)",[32,33,34],"Peripheral nerve evaluation","External trial system","Pilot study","RECRUITING","2026-07-10",{"date":38,"type":39},"2026-07-13","ACTUAL",{"date":41,"type":39},"2026-04-30",{"date":43,"type":21},"2026-12",{"name":45,"class":46},"Axonics, Inc.","INDUSTRY",2,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":60,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":65,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":72},"100053933","evaluation-of-a-non-implanted-electrical-stimulation-device-for-overactive-bladder-oab-100053933","NCT07195656","Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)","Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB) EVANESCE-II","EVANESCE-II","Key Inclusion Criteria:\n\n* Females, defined as a person with a uterus and cervix, ≥21 years old, with a diagnosis of OAB and symptoms for more than 6 months, as confirmed by a physician. OAB is defined by urinary urgency, usually with urinary frequency and nocturia, with or without urgency urinary incontinence with symptoms\n* Willing and able to comply with study required procedures and visits (e.g., maintaining consistent medication use, fluid intake, diary completion).\n\nKey Exclusion Criteria:\n\n* Systemic condition or disease that may interfere with study participation (e.g., current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, history of myocardial infarction, etc.) as determined by study investigator.\n* Not an appropriate study candidate as determined by investigator.","FEMALE","21 Years",{"count":59,"type":21},151,[24],"A study to evaluate the safety and effectiveness of FemPulse System",[30],[64],"neuromodulation",{"date":38,"type":39},{"date":67,"type":39},"2025-09-30",{"date":69,"type":21},"2027-12-31",{"name":71,"class":46},"FemPulse Corporation",15,{"id":74,"slug":75,"hasResults":12,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":12,"sex":56,"minAge":57,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":85,"conditions":86,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":97,"locationsCount":100},"100624124","phase-2-zinc-supplementation-with-botulinum-toxin-for-overactive-bladder-100624124","NCT07405554","Zinc Supplementation With Botulinum Toxin for Overactive Bladder","Effect of Zinc Supplementation on Botulinum Toxin for Overactive Bladder: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n* Non-pregnant adult female at least 21 years old, with no plans to become pregnant during the course of the trial) and if of child-bearing potential, with a negative pregnancy test, and if sexually active, must be using medically acceptable contraception.\n* ≥ 6 urgency urinary incontinence episodes on a 3-day baseline bladder diary, with these urge incontinence episodes representing greater than 50% of the total incontinent episodes recorded.\n* Willing and able to complete all study related items and interviews.\n* Refractory urgency urinary incontinence: defined as persistent symptoms despite at least one or more conservative treatments (e.g. supervised behavioral therapy, supervised physical therapy)\n* Persistent symptoms despite the use of a minimum of two anticholinergics, or unable to tolerate medication due to side effects, or has a contraindication to taking anticholinergic\u002FBeta 3 agonist medication.\n* Currently not on an anticholinergic or antimuscarinic\u002FBeta 3 agonist medication (e.g. oxybutynin, tolterodine, darifenacin, trospium chloride, solifenacin-succinate, fesoterodine and\u002For mirabegron) or be willing to stop medication for 3 weeks prior to completing baseline bladder diary and expected to remain off medications through duration of study.\n* Demonstrates ability (or have caregiver demonstrate ability) to perform clean intermittent self-catheterization.\n* Grossly neurologically normal on exam and no gross systemic neurologic conditions believed to affect urinary function.\n\nExclusion Criteria:\n\n* Neurologic diseases such as multiple sclerosis, Parkinson Disease, CVA within 6 months prior to enrollment, myasthenia gravis, Charcot-Marie-Tooth disease, clinically significant peripheral neuropathy, and complete spinal cord injury.\n* Untreated urinary tract infection (UTI).\n* Any prior use of either study therapy for treatment of urinary urge incontinence (Botox A® or Interstim®).\n* PVR \\>150 ml on 2 occasions within 6 months prior to enrollment (If the PVR value was obtained by ultrasound and was ≥150 ml, the PVR will be confirmed by catheterization which will be the gold standard).\n* Current or prior bladder malignancy.\n* Surgically altered detrusor muscle, such as augmentation cystoplasty.\n* Subjects taking aminoglycosides.\n* Currently pregnant or lactating.\n* Allergy to lidocaine or bupivacaine.\n* Prior pelvic radiation.\n* Uninvestigated hematuria.","100 Years",{"count":82,"type":21},72,[84],"PHASE2","This randomized, double-blind, placebo-controlled trial evaluates whether oral zinc plus phytase supplementation modifies clinical response to intradetrusor botulinum toxin injection in patients with overactive bladder. Participants will receive either zinc plus phytase supplementation or matching placebo for five days prior to intradetrusor botulinum toxin injection. Participants will be followed for six months after treatment to assess need for repeat botulinum toxin injection, urinary symptoms, and patient-reported outcomes related to overactive bladder.",[30],[88,89,90],"overactive bladder","botulinum toxin","zinc","2026-07-01",{"date":93,"type":39},"2026-07-02",{"date":95,"type":39},"2026-02-26",{"date":43,"type":21},{"name":98,"class":99},"Endeavor Health","OTHER",1,{"id":102,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":104,"briefSummary":25,"conditions":105,"keywords":106,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":108,"startDateStruct":110,"completionDateStruct":111,"leadSponsor":112,"locationsCount":47},"100618735",{"count":20,"type":21},[24],[27,28,29,30],[32,33,34],"2026-06-11",{"date":109,"type":39},"2026-06-15",{"date":41,"type":39},{"date":43,"type":21},{"name":45,"class":46},{"id":114,"slug":115,"hasResults":12,"nctId":116,"briefTitle":117,"officialTitle":118,"acronym":4,"eligibilityCriteria":119,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":120,"targetDuration":4,"studyType":22,"phases":122,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":107,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},"100576754","pmcf-study-of-the-axonics-snm-system-model-5101-r20-for-the-indication-of-oab-100576754","NCT06789406","PMCF Study of the Axonics SNM System Model 5101 (R20) for the Indication of OAB","Post-Market Clinical Follow-up Study of the Rechargeable Axonics SNM System Model 5101 (R20) for the Indication of Overactive Bladder (OAB)","Inclusion Criteria:\n\n1. 18 years or older\n2. Primary indication of OAB (urinary urgency incontinence (UUI) \u002F urinary frequency (UF) who are not candidates for, or who have failed conservative treatment\n3. Willing and capable to provide written consent and agrees to comply with specified evaluations at clinical centers for all follow-up assessments\n\nExclusion Criteria:\n\n1. Any significant medical condition that is likely to interfere with procedures, device operation, or likely to confound evaluation of endpoints (i.e., neurological conditions such as multiple sclerosis)\n2. Any psychiatric or personality disorder that is likely to interfere with procedures at the discretion of the participating physician; this may include poor understanding or compliance with requirements\n3. Previously underwent an external sacral neuromodulation SNM trial and was deemed a non-responder or was previously implanted with a sacral neuromodulation device and did not get therapeutic benefit (a non-responder)\n4. History of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone\n5. A female who is breastfeeding\n6. A female with a positive urine pregnancy test",{"count":121,"type":21},55,[24],"Post-market clinical follow-up for continued assessment of safety and performance to confirm long-term outcomes of the Axonics SNM System INS Model 5101.",[27,28,30],{"date":109,"type":39},{"date":127,"type":39},"2025-09-18",{"date":129,"type":21},"2031-10",{"name":45,"class":46},5,{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":56,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":22,"phases":143,"briefSummary":144,"conditions":145,"keywords":147,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":154,"completionDateStruct":156,"leadSponsor":158,"locationsCount":100},"100643811","a-novel-wearable-transcutaneous-tibial-nerve-stimulation-ttns-device-in-the-treatment-of-patients-with-overactive-bladder-oab-and-nocturia-100643811","NCT07635251","A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia","A Novel Wearable Transcutaneous Tibial Nerve Stimulation (TTNS) Device Combined With Behavioral Therapy (BT) Versus Behavioral Therapy in the Treatment of Patients With Overactive Bladder (OAB) and Nocturia: a Prospective, Randomized Controlled Study","Inclusion Criteria:\n\n1. age ≥20 years old, ≤80 years old, female;\n2. patients with overactive bladder (OAB) symptoms for more than 8 weeks; The inclusion criteria were as follows: voiding frequency ≥8 times in 24 hours, urgency attack ≥1 time in 24 hours, nocturnal voiding ≥2 times (OABSS score ≥6 points), and nocturnal polyuria index (NPi) ≤0.33.\n3. the patient's physical condition is stable and can be treated at home;\n4. All participants volunteered to participate in the study and provided written informed consent before the study began.\n\nExclusion Criteria:\n\n1. Residual urine volume ≥100 mL;\n2. difficulty walking;\n3. urethral stricture;\n4. bladder stones;\n5. bladder cancer;\n6. urinary tract infection;\n7. pregnant, lactating women, women of childbearing age who plan to become pregnant during the study or who do not use safe contraception;\n8. pelvic organ prolapse;\n9. neuropsychiatric disorders (including cerebrovascular diseases) associated with neurogenic bladder;\n10. taking medications for urinary system diseases within 2 weeks before enrollment;\n11. patients with mental and cognitive impairment who are unable to cooperate with treatment;\n12. other conditions considered by the investigator to be inappropriate for study participation.","20 Years","80 Years",{"count":142,"type":21},80,[24],"Overactive bladder (OAB) is a syndrome with urgency as the main symptom, usually accompanied by frequent urination, nocturia, and sometimes urge urinary incontinence. Globally, the prevalence of OAB in the general population has been reported to be about 20%. Nocturia was defined as the patient waking up at least once during the night to urinate. Among lower urinary tract symptoms, nocturia can significantly affect daily life and quality of life. Reported causes of nocturia include nocturnal polyuria, sleep disorders, circadian rhythm disruption (e.g., circadian rhythm sleep disorders), and reduced bladder capacity. Because overactive bladder (OAB) may be associated with reduced bladder capacity, anticholinergic agents are used as standard therapy in the management of nocturia associated with OAB. However, anticholinergic medications are associated with poor adherence, such as inadequate efficacy and adverse effects (e.g., dry mouth, constipation, and cognitive impairment). Therefore, it is imperative to find alternative therapies for anticholinergic drugs.\n\nPrevious studies have shown that transcutaneous tibial nerve stimulation (TNS) can also significantly improve lower urinary tract symptoms, such as frequency, urgency, incontinence, and nocturia, and is also one of the options for the treatment of OAB. A previous study also demonstrated its improvement in sleep quality in women with nocturia. However, the efficacy of tibial nerve stimulation in the treatment of active bladder with nocturia is still a blank, and further studies are needed.",[30,146],"Nocturia",[148,88,149],"transcutaneous tibial nerve stimulation","nocturia","NOT_YET_RECRUITING","2026-06-03",{"date":153,"type":39},"2026-06-09",{"date":155,"type":21},"2026-06-10",{"date":157,"type":21},"2027-06-10",{"name":159,"class":99},"Qilu Hospital of Shandong University",{"id":161,"slug":162,"hasResults":12,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":4,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":140,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":172,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":175,"startDateStruct":176,"completionDateStruct":177,"leadSponsor":179,"locationsCount":100},"100643484","efficacy-of-probiotics-for-oab-patients-with-anxiety-100643484","NCT07635212","Efficacy of Probiotics for OAB Patients With Anxiety","Evaluating the Efficacy of Probiotics as an Adjunct to Behavioral Therapy in Patients With Overactive Bladder (OAB) and Anxiety Symptoms: A Randomized, Double-Blind, Placebo-Controlled Trial","Inclusion Criteria:\n\n1. Aged between 18 and 80 years old (inclusive).\n2. Able to understand study-related instructions and independently complete the required questionnaires.\n3. Able to provide written informed consent and willing to comply with all study requirements, including completing diaries\u002Fquestionnaires and refraining from taking any other probiotic or prebiotic supplements during the 3-month study period.\n4. Meet the diagnostic criteria for Overactive Bladder (OAB) as defined by the International Continence Society (ICS) (urgency as the core symptom, with or without urgency urinary incontinence, frequency, and nocturia); have an Overactive Bladder Symptom Score (OABSS) ≥ 6; and have a daytime voiding frequency of ≥ 8 times.\n5. Have a preliminary diagnosis of \"Generalized Anxiety Disorder\" or \"Anxiety state\" assessed by a psychiatrist or trained investigator according to DSM-5 or ICD-10 criteria, or have a Generalized Anxiety Disorder-7 (GAD-7) scale score ≥ 5.\n6. If previously using any over-the-counter medications or other products for anxiety relief (e.g., magnesium, melatonin, anticholinergic drugs) or receiving psychotherapy, these must have been discontinued for at least 4 weeks prior to randomization and must remain completely discontinued throughout the entire study period.\n\nExclusion Criteria:\n\n1. Presence of organic diseases of the urinary system (e.g., urinary tract obstruction, tumors, stones, acute infection, interstitial cystitis, stress urinary incontinence).\n2. Neurogenic bladder caused by neurological diseases or a history of pelvic surgery.\n3. Use of antibiotics, probiotics, or prebiotics within the past 1 month prior to screening.\n4. Any adjustment to medications used for treating OAB or anxiety within the past 2 weeks prior to screening.\n5. Pregnant or lactating women, or individuals with a known allergy to any components of the study preparation.\n6. Suffering from other severe psychiatric\u002Fpsychological disorders or severe systemic diseases (e.g., uncontrolled diabetes mellitus, severe obesity).",{"count":168,"type":21},218,[24],"The goal of this clinical trial is to learn if probiotics can help improve symptoms in adults with overactive bladder (OAB) and anxiety. The main questions it aims to answer are:\n\n1. Does taking probiotics lower the number of times participants need to urinate in a 24-hour period?\n2. Does taking probiotics lower participants' anxiety levels?\n\nResearchers will compare probiotics to a placebo (a look-alike powder that contains no active bacteria) to see if the probiotics work better to treat OAB and anxiety when both groups also use standard behavioral therapy (like bladder training).\n\nParticipants will:\n\n1. Take probiotics or a placebo twice a day for 12 weeks.\n2. Learn and practice bladder training using a manual and educational videos.\n3. Keep a 3-day diary of when they urinate and what they drink at the beginning, middle, and end of the study.\n4. Answer survey questions about their anxiety and quality of life during clinic visits.\n5. Provide urine samples for routine checkups to ensure they do not have infections.",[30],[173,174,88],"probiotics","OAB",{"date":153,"type":39},{"date":91,"type":21},{"date":178,"type":21},"2028-12-31",{"name":159,"class":99},{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":187,"targetDuration":4,"studyType":22,"phases":189,"briefSummary":190,"conditions":191,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":192,"lastUpdatePostDateStruct":193,"startDateStruct":195,"completionDateStruct":197,"leadSponsor":199,"locationsCount":47},"100607811","inopase---performance-and-safety-study-of-a-personalised-snm-system-100607811","NCT07193407","INOPASE - Performance and Safety Study of a Personalised SNM System","Feasibility and Safety Study to Evaluate the Sensing and Stimulation Performance of a Personalised Sacral Neuromodulation (SNM) System for Refractory Overactive Bladder","Inclusion Criteria:\n\n1. Adult female participants 18 years of age or older\n2. Diagnosed with refractory overactive bladder that is resistant to behavioural therapy and\u002For pharmacotherapy, for at least 12 weeks\n3. Experience at least 3 urgency episodes within a 24-hour period from the past 3 consecutive days (reported in a bladder diary)\n4. Baseline of greater than 7 on the Overactive Bladder Symptom Score (OABSS)\n5. Baseline score of greater than 12 on the International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)\n6. Willing to receive SNM therapy\n7. Willing to provide free and Informed consent to participate in the clinical investigation\n8. Able to understand all study instructions, willing to attend all study visits, and likely to comply with all study procedures\n\nExclusion Criteria:\n\n1. Participants who are diagnosed with stress urinary incontinence\n2. Received tibial nerve stimulation therapy within the past 3 months\n3. Received treatment of urinary symptoms with botulinum toxin in the past 9 months or any plan to have botulinum toxin treatment during the study\n4. Have neurological conditions such as dementia, multiple sclerosis, clinically significant peripheral neuropathy or spinal cord injury\n5. Participants who presently have, or are at high risk of urinary tract infection\n6. Have uncontrolled systemic disease or comorbidities which may affect bladder function (for example diabetes, hypertension, cancer)\n7. Implanted with a neurostimulator, pacemaker, or defibrillator\n8. Participation in another interventional drug or device clinical trial concurrently or concluding within 30 days of screening\n9. Women who are pregnant\n10. Participants with known history of allergies to materials in contact with tissue for this study (i.e. adhesive dressing patch, silicone)\n11. Have implanted devices that contain metallic components within 2cm of the implanted lead location\n12. Any other clinical or social reason that, in the opinion of the investigator could restrict a participant's ability to successfully meet the study objectives",{"count":188,"type":21},10,[24],"The goal of this clinical trial is to learn whether a new sacral neuromodulation (SNM) system (INO-SNM-01) can safely and effectively sense bladder nerve activity and provide stimulation to help manage symptoms of refractory overactive bladder in adult women aged 18-70 who have not responded to standard treatments.\n\nThe main questions it aims to answer are:\n\n* Is there a clear relationship between bladder nerve activity and patient-reported urgency sensations?\n* Can targeted stimulation based on bladder nerve activity reduce overactive bladder symptoms?\n* Is the INO-SNM-01 System safe to use?\n\nResearchers will not use a comparison group in this study. Instead, all participants will receive the investigational device to see if it works as intended.\n\nParticipants will undergo surgery to have a temporary trial lead implanted near the sacral nerve and spend up to 2 days in hospital for monitoring and testing to assess the device sensing and stimulation capabilities.\n\nUp to 10 participants will take part in this first-in-human feasibility study at a single site in Australia.",[30],"2026-05-15",{"date":194,"type":39},"2026-05-18",{"date":196,"type":39},"2026-02-27",{"date":198,"type":21},"2026-12-31",{"name":200,"class":46},"INOPASE Pty Ltd",{"id":202,"slug":203,"hasResults":12,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":209,"targetDuration":4,"studyType":211,"phases":4,"briefSummary":212,"conditions":213,"keywords":215,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":41,"lastUpdatePostDateStruct":232,"startDateStruct":234,"completionDateStruct":235,"leadSponsor":237,"locationsCount":4},"100634858","real-world-experiences-and-voices-exploring-the-actual-lived-burden-of-oab-a-mixed-methods-multi-country-proms-study-on-oab-patients-quality-of-life-100634858","NCT07545148","Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life","REVEAL-OAB. Real-world Experiences and Voices Exploring the Actual Lived Burden of OAB: A Mixed-methods Multi-country PROMs Study on OAB Patients' Quality of Life","REVEAL-OAB","Inclusion Criteria:\n\n* If they are over 18 years old.\n* They have been told by a doctor or other healthcare professional that they have symptoms that match OAB, or have been given a diagnosis of OAB.\n* They live in France, Germany, Italy, the Netherlands, Poland, Spain, Sweden, or the UK.\n* They have received the Patient Information Sheet from their health care provider, during an appointment, via email, or postal mail.\n* They can confirm they understand the Patient Information Sheet and that they want to take part in this study.\n\nExclusion Criteria:\n\n* They have not received information on this study from their own health care provider\n* They have a confirmed neurological condition known to affect bladder function (for example: multiple sclerosis, Parkinson's disease, spinal cord injury).\n* They have undergone major surgery directly involving the bladder, prostate, urethra, or pelvic structures that affect urinary function.\n* They presently have a urinary tract infection (UTI).\n* They have or have had cancer in their bladder, kidneys, prostate, or other urinary or reproductive organs",{"count":210,"type":21},2000,"OBSERVATIONAL","The main goal is to understand what it is truly like to live with OAB from the patient's perspective, including how it affects: daily activities, emotional wellbeing and mental health, social life and relationships, work and overall quality of life.",[30,214],"Overactive Bladder Syndrome",[216,217,218,219,220,221,222,223,224,225,226,227,228,229,230,231],"Real-world evidence;","Patient-centred research","Mixed-method study","International, multi-country study","Observational study","Overactive bladder (OAB) burden","Quality of life (QoL)","Emotional and psychosocial impact","Quantitative surveys","Patient-reported outcomes (PROs)","Qualitative interviews","Evidence to inform clinical practice and policy","Unmet needs in care","Real-life disease impact","Symptom impact and severity","Lived patient experience",{"date":233,"type":39},"2026-05-06",{"date":91,"type":21},{"date":236,"type":21},"2027-02-01",{"name":238,"class":99},"European Association of Urology Research Foundation",{"id":240,"slug":241,"hasResults":12,"nctId":242,"briefTitle":243,"officialTitle":244,"acronym":245,"eligibilityCriteria":246,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":140,"enrollmentInfo":247,"targetDuration":4,"studyType":22,"phases":249,"briefSummary":250,"conditions":251,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":253,"startDateStruct":255,"completionDateStruct":257,"leadSponsor":259,"locationsCount":4},"100635467","phase-2-relieve-study-nt-201-intravesical-administration-using-vibe-system-vixe-combination-product-for-the-treatment-of-idiopathic-overactive-bladder-100635467","NCT07553065","RELIEVE Study: NT 201 Intravesical Administration Using Vibe System (ViXe Combination Product) for the Treatment of Idiopathic Overactive Bladder","RELIEVE (RandomizEd triaL of Intravesical xEomin for Incontinence Via the VibE System) - a Randomized, Prospective, Multicenter, Double Blind, Placebo and Sham Controlled Study to Assess the Safety and Efficacy of NT 201 Intravesical Administration Using Vibe System in the Treatment of Female Participants Suffering From Idiopathic Overactive Bladder","RELIEVE","Key Inclusion Criteria:\n\n1. Signed written informed consent\n2. Female aged 18-80\n3. Participant with known idiopathic Overactive Bladder condition based on medical records for at least 6 months prior to enrollment\n4. Participant with at least 8 daily urinary output episodes on average during a 3-day voiding diary\n5. Participant with at least 5 Urinary Incontinence episodes during a 3-day voiding diary and at least 1 per day\n6. Participants on antimuscarinics and\u002For beta-3 adrenergic agonists drugs should be on a stable dose for at least 1 month prior to screening and agree to remain on stable medication consumption until the 12-week follow-up visit\n7. Participants on tricyclic antidepressants, Selective Serotonin Reuptake Inhibitors (SSRI) and Serotonin-Norepinephrine Reuptake Inhibitors (SNRI) drugs should be on stable dose for at least 3 months prior to enrollment and agree to remain on stable medication consumption until the 12-week follow-up visit\n\nKey Exclusion Criteria:\n\n1. Participant with Body Mass Index \\> 40 kg\u002Fm2\n2. Participant with history of evidence of pelvic, urological or urogenital abnormality that in the determination of the investigator would interfere with study conduct\n3. Participant with known or suspected overactive bladder caused by any neurological conditions (neuromuscular disorders such as Myasthenia Gravis, Amyotrophic Lateral Sclerosis (ALS), Eaton-Lambert Syndrome, Alzheimer's, Parkinson, Multiple Sclerosis (MS), stroke, etc.)\n4. Participant with suspected retention or with Post Void Residue (PVR)\\> 150 ml, as measured during screening. Post void residual may be repeated one week after first assessment if the original value is greater than 150 ml\n5. Participant is pregnant or breastfeeding\n6. Participant with current or known recurrent urinary tract infection (3 or more infections in the last 6 months), or presence of urinary fistula, or urinary tract obstruction such as cancer, urethral stricture or presence of urinary stone\n7. Participant who has received botulinum toxin injections for any condition within the past 9 months\n8. Participant who has received neurostimulation for the treatment of Overactive Bladder in the last 6 months.\n9. Participant on any active biofeedback, pelvic muscle rehabilitation, or pelvic floor physical therapy within the past 4 weeks (Self-performed Kegels exercises are allowed)\n10. Participant with more than minimal level of suspected stress incontinence or mixed incontinence with stress component likely to confound study outcome, based on a 3-day voiding diary or medical history, or when stress incontinence score in the Medical, Epidemiologic, and Social Aspects (MESA) incontinence questionnaire is higher than the urgency incontinence score\n11. Participant with current or planned treatment with drugs that interfere with neuromuscular transmission (e.g., aminoglycoside, polypeptide antibiotics, lincomycin antibiotics, or aminoquinolines as well as tubocurarine-type muscle relaxants)",{"count":248,"type":21},210,[84],"This Phase 2b study is a prospective, multicenter, double blind, randomized, placebo and sham controlled trial to assess the safety, efficacy and dose response of NT 201 delivered by the Vibe System in participants with idiopathic overactive bladder (OAB).",[30],"2026-04-22",{"date":254,"type":39},"2026-04-27",{"date":256,"type":21},"2026-07",{"date":258,"type":21},"2027-12",{"name":260,"class":46},"Vensica Therapeutics Ltd.",{"id":262,"slug":263,"hasResults":12,"nctId":264,"briefTitle":265,"officialTitle":266,"acronym":4,"eligibilityCriteria":267,"healthyVolunteers":12,"sex":17,"minAge":268,"maxAge":4,"enrollmentInfo":269,"targetDuration":4,"studyType":22,"phases":271,"briefSummary":272,"conditions":273,"keywords":274,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":278,"startDateStruct":280,"completionDateStruct":282,"leadSponsor":284,"locationsCount":286},"100616076","tensi-for-treating-overactive-bladder-100616076","NCT07300904","Tensi+ for Treating Overactive Bladder","A Randomized, Controlled, Blinded, Prospective, Multi-center Study Evaluating Tensi+ With Transcutaneous Tibial Nerve Stimulation for the Treatment of Overactive Bladder Syndrome","Inclusion Criteria:\n\n* Adult subjects aged 22 years or older and,\n* Diagnosed with OAB symptoms (characterized by urinary urgency, with or without UUI),\n* Symptoms persisting for at least 3 months, and\n* Documented with 2 or more urgency episodes per day (with or without incontinence) in two 3-day bladder diaries and,\n* With at least 11 or more voids per day (urinary frequency) documented in two 3-day bladder diaries\n* Willing and capable of providing informed consent\n* Capable of participating in all testing associated with this clinical investigation\n\nExclusion Criteria:\n\n* Patients with pacemakers or implanted defibrillators or any other implanted electronic device\n* Patients prone to excessive bleeding\n* Patients with nerve damage that could impact the percutaneous tibial nerve or pelvic floor function\n* Patients who are pregnant or planning to become pregnant while using this product\n* Patients with ankle joint problems, ankle oedema or dermatological oedema in the area where the electrodes should be placed\n* Patients wearing a metal implant near the stimulated area\n* Patient with cognitive deficiency\n* Administration of intravesical injection of botulinum toxin within 12 months of study enrollment, or treatment within the previous year with other forms neuromodulation for OAB\n* Patients treated with medical therapy OAB treatment washout inferior to 30 days\n* Patients with diabetic neuropathy\n* Patients with uncontrolled diabetes and HbA1c levels above 7%\n* Guillain-Barré syndrome\n* Chronic inflammatory demyelinating polyneuropathy (CIDP)\n* Multiple sclerosis\n* A primary diagnosis of stress urinary incontinence (SUI)\n* Patients with recurrent rrinary tract infections (UTIs) defined as more than 2 episodes per year, or with any baseline lower urinary tract pathology identified at the time of the 3-day bladder diary assessment.\n* Currently participating in another clinical trial","22 Years",{"count":270,"type":21},60,[24],"The purpose of the study is to evaluate the safety and effectiveness of the Tensi+ device using Transcutaneous Posterior Tibial Nerve Stimulation (TPTNS) for treating patients suffering from OAB symptoms urinary frequency, urgency, with or without urge urinary incontinence.",[30],[275,276,277],"Overactive Bladder","Transcutaneous Tibial Nerve Stimulation","Urology",{"date":279,"type":39},"2026-04-28",{"date":281,"type":21},"2026-05",{"date":283,"type":21},"2027-01",{"name":285,"class":46},"Stimuli Technology",3,{"id":288,"slug":289,"hasResults":12,"nctId":290,"briefTitle":291,"officialTitle":291,"acronym":4,"eligibilityCriteria":292,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":293,"targetDuration":4,"studyType":22,"phases":295,"briefSummary":296,"conditions":297,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":252,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":100},"100588668","evaluating-pumpkin-seed-oil-extract-supplementation-on-bladder-function-100588668","NCT06944392","Evaluating Pumpkin Seed Oil Extract Supplementation on Bladder Function","Inclusion Criteria:\n\n* All patients evaluated at Northwestern's IPHP who report bladder function consistent with overactive bladder (urinary urgency, with or without urinary frequency more than 8 times daily or nocturia, with or without urgency urinary incontinence) at their index visit, who are also willing to use a dietary supplement and not initiate additional behavioral, medication or procedural treatment for 12 weeks following pumpkin seed oil extract initiation.\n\nExclusion Criteria:\n\n* Patients with any of the following will be excluded from the study:\n* Use of other supplements that contain pumpkin seed oil\n* ≥Stage 3 pelvic organ prolapse\n* Urinary post-void residual ≥150cc\n* Culture-proven urinary tract infection at time of study enrollment\n* Recurrent urinary tract infection\n* Neurogenic bladder\n* Abdominal or pelvic malignancy\n* Initiation of new overactive bladder medications or supplements during study period or in the 3 months immediately preceding study enrollment\n* History of surgery in the past 12 months for pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence, or fecal or flatal incontinence\n* Patient's primary language is not English",{"count":294,"type":21},40,[24],"This is a pilot study to assess using validated outcome measures how ingesting pumpkin seed oil extract supports patient bladder function in a United States population.",[30],{"date":299,"type":39},"2026-04-23",{"date":301,"type":39},"2025-04-11",{"date":303,"type":21},"2026-10-01",{"name":305,"class":99},"Northwestern University",{"id":307,"slug":308,"hasResults":12,"nctId":309,"briefTitle":310,"officialTitle":311,"acronym":4,"eligibilityCriteria":312,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":313,"enrollmentInfo":314,"targetDuration":4,"studyType":22,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":100},"100634483","effectiveness-of-ambulatory-transcutaneous-tibial-nerve-stimulation-for-overactive-bladder-100634483","NCT07540273","Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation for Overactive Bladder","A Single-Center Randomized Controlled Trial Evaluating the Effectiveness of Ambulatory Transcutaneous Tibial Nerve Stimulation Compared to Conventional Protocol in Patients With Overactive Bladder","Inclusion Criteria:\n\n* Adults aged 18 to 65 years\n* Clinical diagnosis of overactive bladder (OAB)\n* Working in an office setting or spending most of the day at home, suitable for using a portable TENS device\n\nExclusion Criteria:\n\n* Pregnancy\n* Cardiac pacemaker\n* Epilepsy\n* Metal implant in the ankle area\n* Open wound or skin disease at the electrode site\n* Active urinary tract infection\n* Neurological disease affecting bladder function\n* Previous surgery for urinary incontinence or OAB\n* Current anticholinergic or beta-3 agonist use for OAB\n* Cognitive impairment preventing proper device use","65 Years",{"count":270,"type":21},[24],"The goal of this clinical trial is to learn if using a portable nerve stimulation (TENS) device during daily life works to reduce overactive bladder (OAB) symptoms in adults aged 18 to 65. The main questions it aims to answer are:\n\n* Does using TENS at home during daily activities reduce the number of urgency episodes?\n* Does this approach improve bladder symptoms and quality of life as much as clinic-based treatment?\n\nResearchers will compare two ways of using TENS applied to the ankle area (tibial nerve stimulation):\n\n* Group 1 (Clinic-based): Participants will visit the clinic twice a week for 2 weeks and receive 30-minute TENS sessions.\n* Group 2 (Ambulatory): Participants will use a portable TENS device at home during their daily routine when they feel the urge to urinate, over a 2 week period.\n\nBoth groups will use the same electrical settings (20 Hz frequency, 200 µs pulse width).\n\nParticipants will:\n\n* Complete bladder symptom questionnaires before and after the study\n* Fill in a 3-day voiding diary to track how often they urinate, urgency episodes, and any leakage\n* Answer quality of life questions at the start and at 4 weeks",[30,318],"Urinary Urgency",[276,275,320,321,318],"Ambulatory Neuromodulation","Self-Administered Electrical Stimulation","2026-04-17",{"date":324,"type":39},"2026-04-20",{"date":326,"type":21},"2026-04-15",{"date":328,"type":21},"2026-12-15",{"name":330,"class":331},"SEZGIN","OTHER_GOV",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":349,"lastUpdatePostDateStruct":350,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":355,"locationsCount":100},"100629333","phase-4-low-intensity-shockwave-therapy-versus-solifenacin-for-the-treatment-of-overactive-bladder-in-women-100629333","NCT07473310","Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women","Low-intensity Shockwave Therapy Versus Solifenacin for the Treatment of Overactive Bladder in Women: A Randomized Controlled Trial","Inclusion Criteria:\n\n* OAB symptoms persisting for ≥3 months.\n* OAB Symptom Score (OABSS) ≥7.\n* Ability and willingness to provide informed consent\n\nExclusion Criteria:\n\n* Active urinary tract infection.\n* Stress urinary incontinence as primary diagnosis.\n* Pelvic organ prolapse stage ≥II.\n* History of pelvic radiation or surgery within 6 months.\n* Use of anticholinergics or β3-agonists for the past 4 weeks who are unwilling to undergo washout.\n* Pregnancy or breast feeding.\n* Neuropathic diseases or psychological disorders.\n* History of urogenital malignancy.\n* Uncontrolled DM (HbA1c \\> 6.8)\n* Uncorrected coagulopathy or severe cardiovascular disease.\n* Contraindication to solifenacin e.g.: closed angle glaucoma)",{"count":340,"type":21},70,[342],"PHASE4","The goal of this clinical trial is to evaluate the effectiveness and safety of low-intensity shockwave therapy (Li-SWT) for the treatment of overactive bladder (OAB) in adult women.\n\nThe main questions this study aims to answer are whether Li-SWT improves overactive bladder symptoms and quality of life, and whether these improvements are sustained over a 12-month follow-up period, compared with standard medical therapy.\n\nResearchers will compare Li-SWT with oral solifenacin succinate, a commonly used antimuscarinic medication for OAB.\n\nParticipants will be randomly assigned to receive either Li-SWT once weekly for 8 weeks or solifenacin 5 mg taken orally once daily for 12 months. All participants will complete symptom questionnaires and three-day voiding diaries and will undergo uroflowmetry, post-void residual measurement, and filling cystometry at specified time points during follow-up.",[30,345],"Urge Incontinence",[174,88,347,348],"low intensity shockwave","solifenacin","2026-03-10",{"date":351,"type":39},"2026-03-16",{"date":353,"type":39},"2025-11-11",{"date":258,"type":21},{"name":356,"class":99},"Mansoura University",{"id":358,"slug":359,"hasResults":12,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":365,"enrollmentInfo":366,"targetDuration":4,"studyType":22,"phases":368,"briefSummary":369,"conditions":370,"keywords":371,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":384,"locationsCount":385},"100625002","phase-4-randomized-controlled-trial-comparing-low-dose-tadalafil-versus-solifenacin-for-management-of-overactive-bladder-in-women-multicenter-egyptian-national-study-100625002","NCT07416968","Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study","Randomized Controlled Trial Comparing Low Dose Tadalafil Versus Solifenacin For Management of Overactive Bladder in Women: Multicenter Egyptian National Study (WoMEN'S)","WoMEN'S","Inclusion Criteria:\n\n* OAB symptoms persisting for ≥3 months\n* OAB Symptom Score (OABSS) \\> 5 and urgency sub-score of OABSS ≥ 2\n* Ability and willingness to provide informed consent.\n\nExclusion Criteria:\n\n* Active urinary tract infection.\n* Stress urinary incontinence (SUI) as primary diagnosis, or mixed urinary incontinence with predominant SUI\n* Pelvic organ prolapse stage ≥II according to POP-Q system.\n* History of pelvic radiation.\n* History of neurosurgical interventions.\n* Pregnancy or breastfeeding.\n* Neuropathic diseases affecting the lower urinary tract.\n* History of genitourinary malignancy.\n* Post-void residual urine (PVR) \\> 150 ml.\n* Vesical or lower ureteric stones.\n* Uncontrolled diabetes mellitus (HbA1c \\> 7).\n* Any psychological or psychiatric disorders.\n* Contraindications or allergy to the used medications.\n* History of surgeries in the urinary bladder.\n* History of pelvic surgeries within 6 months.\n* Voiding dysfunctions.","75 Years",{"count":367,"type":21},480,[342],"Researchers are studying two medicines to see which works better for women with overactive bladder (OAB). OAB causes sudden urges to urinate, frequent bathroom trips, and sometimes leakage.\n\nWomen who join the study will be randomly placed into one of two groups:\n\nOne group will take tadalafil (5 mg), a medicine taken once a day.\n\nThe other group will take solifenacin (5 mg), a common treatment for OAB, also taken once a day.\n\nThe study will last 12 weeks. Participants will keep a bladder diary, answer short questionnaires, and have simple urine flow and bladder tests at several visits.\n\nThe main goal is to find out which medicine lowers OAB symptoms more, such as urgency and frequent urination. Researchers will also look at quality of life, bladder function, and side effects.\n\nWomen aged 18 to 75 years with OAB symptoms for at least 3 months may be able to take part.",[30,214],[275,174,372,373,374,375,376,377],"Tadalafil","Solifenacin","Low dose tadalafil","Urgency","frequency","Urge Urinary Incontinence","2026-02-17",{"date":380,"type":39},"2026-02-18",{"date":382,"type":39},"2025-09-01",{"date":43,"type":21},{"name":356,"class":99},14,{"id":387,"slug":4,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":12,"sex":56,"minAge":57,"maxAge":4,"enrollmentInfo":388,"targetDuration":4,"studyType":22,"phases":389,"briefSummary":61,"conditions":390,"keywords":391,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":392,"lastUpdatePostDateStruct":393,"startDateStruct":395,"completionDateStruct":396,"leadSponsor":397,"locationsCount":72},"100607984",{"count":59,"type":21},[24],[30],[64],"2026-02-04",{"date":394,"type":39},"2026-02-06",{"date":67,"type":39},{"date":69,"type":21},{"name":71,"class":46},{"id":399,"slug":400,"hasResults":12,"nctId":401,"briefTitle":402,"officialTitle":403,"acronym":4,"eligibilityCriteria":404,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":405,"targetDuration":4,"studyType":22,"phases":406,"briefSummary":407,"conditions":408,"keywords":409,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":411,"lastUpdatePostDateStruct":412,"startDateStruct":413,"completionDateStruct":415,"leadSponsor":417,"locationsCount":100},"100623072","phase-2-evaluate-the-safety-and-efficacy-of-trg-200-kit-in-patients-with-refractory-overactive-bladder-100623072","NCT07391878","Evaluate the Safety and Efficacy of TRG-200 KIT in Patients With Refractory Overactive Bladder.","Open-Label Study to Evaluate the Safety and Efficacy of Two Doses of TRG-200 KIT in Patients With Refractory Overactive Bladder (OAB) : A Pilot Study","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent and comply with all study procedures.\n2. Male or female adults aged 18 years or older.\n3. Documented diagnosis of overactive bladder (OAB) for more than 6 months, refractory or intolerant to oral anticholinergic or other OAB therapies.\n\n   OAB is defined as urinary urgency, usually accompanied by frequency and\u002For nocturia, with or without urgency urinary incontinence.\n4. Ability to perform and tolerate urethral catheterization for intravesical instillation.\n5. Meets the following criteria based on the 3-day voiding diary completed at both the Run-in and Baseline visits:\n\n   1. Average of ≥8 micturitions per day, and\n   2. Average of ≥3 urgency episodes per day, and\n   3. Average of ≥2 nocturia episodes per night.\n6. Participants who report significant improvement during the Run-in phase may continue in the study, provided they meet all inclusion criteria, following consultation with the investigator and based on their self-reported assessment.\n7. Post-void residual (PVR) urine volume \\\u003C150 mL.\n8. Negative urine culture at screening.\n9. Women of childbearing potential must have a negative serum pregnancy test at screening and agree to use effective contraception throughout the study.\n10. Stable medical condition, without acute illness, as determined by the investigator.\n11. Demonstrated ability to complete the 3-day voiding diary as reviewed at the Run-in and Baseline visits.\n\nExclusion Criteria:\n\n1. Pregnant or breastfeeding women, or women of childbearing potential not using acceptable contraception.\n2. Known contraindication, hypersensitivity, or allergy to oxybutynin or other anticholinergic agents.\n3. History of 24-hour urine volume \\>3,000 mL.\n4. Active urinary tract infection or genitourinary infection at screening (re-screening allowed once after treatment).\n5. Lower urinary tract pathology that may account for symptoms, including but not limited to:\n\n   urethral diverticulum, radiation cystitis, tuberculosis cystitis, neurogenic bladder, vaginal candidiasis, urolithiasis, interstitial cystitis, urothelial tumor, clinically significant benign prostatic hyperplasia with obstruction, bladder outlet obstruction, prostatitis, prostate or gastrointestinal cancer.\n6. Structural abnormalities of the bladder (e.g., diverticula, stones) or urogenital anatomical defects.\n7. History of bladder tumors or prostate cancer within the past 5 years, or history of non-muscle invasive bladder cancer (low-grade) within the past 5 years.\n8. Ongoing or planned treatment for urologic or gynecologic malignancy.\n9. Requirement for indwelling catheter or clean intermittent catheterization (CIC), implanted nerve stimulator, or prior procedures affecting bladder function.\n10. Renal insufficiency or serum creatinine \\>1.5 times the upper limit of normal, or patients on dialysis.\n11. Recent pelvic surgery or pelvic radiation within the past 6 months.\n12. Neurological conditions affecting bladder function or contraindicating catheterization.\n13. Alcohol or drug abuse.\n14. Uncontrolled diabetes mellitus.\n15. Hemodynamic instability, including abnormal heart rate, respiratory rate, blood pressure, or oxygen saturation outside protocol-defined ranges.\n16. Unstable cardiovascular disorders, including but not limited to myocardial infarction, ischemic heart disease, atrial fibrillation, heart block, Wolff-Parkinson-White syndrome, bradycardia, coronary artery disease, or QT prolongation.\n17. History of significant liver dysfunction, gastrointestinal bleeding, renal disease, seizures, inflammatory bowel disease, or hepatitis.\n18. Clinically significant hematologic abnormalities, including leukopenia, thrombocytopenia, or anemia below protocol-defined thresholds.\n19. Body mass index (BMI) ≥40 kg\u002Fm².\n20. Any medical condition that, in the investigator's opinion, may place the participant at increased risk, confound study results, or interfere with study conduct.\n21. Recent changes (within 8 weeks) in lower urinary tract interventions, including neuromodulation, tibial nerve stimulation, pelvic floor muscle training, or biofeedback.\n22. Lifetime history of psychotic or bipolar disorder.\n23. Active genital herpes or vaginitis.\n24. Women with urinary symptoms occurring exclusively during menstruation.\n25. Participation in another interventional clinical trial within 30 days prior to screening.",{"count":270,"type":21},[84],"This is an open-label, single-center pilot study designed to evaluate the safety, tolerability, and preliminary efficacy of TRG-200 KIT, an intravesical sustained-release oxybutynin formulation, in adult patients with refractory overactive bladder (OAB). The study includes an adaptive two-stage design with initial dose evaluation of two dose levels (150 mg and 300 mg oxybutynin) followed by expansion using the selected dose. TRG-200 KIT is administered via monthly intravesical instillation and aims to provide prolonged local bladder exposure while minimizing systemic absorption and anticholinergic adverse effects.",[30],[410],"Refractory Overactive Bladder (OAB)","2026-01-29",{"date":394,"type":39},{"date":414,"type":21},"2026-02-15",{"date":416,"type":21},"2027-12-15",{"name":418,"class":46},"Trigone Pharma Ltd.",{"id":420,"slug":421,"hasResults":12,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":425,"eligibilityCriteria":426,"healthyVolunteers":12,"sex":56,"minAge":268,"maxAge":140,"enrollmentInfo":427,"targetDuration":4,"studyType":22,"phases":429,"briefSummary":430,"conditions":431,"keywords":436,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":443,"lastUpdatePostDateStruct":444,"startDateStruct":446,"completionDateStruct":448,"leadSponsor":450,"locationsCount":452},"100609041","detrusor-nerve-radiofrequency-ablation-for-overactive-bladder-in-women-100609041","NCT07209397","Detrusor Nerve Radiofrequency Ablation for Overactive Bladder in Women","A Randomized, Prospective, Multicenter, Double-Blind, Sham-Controlled Study to Assess the MORPHEUSV Radiofrequency (RF) Device in the Treatment of Female Patients With Idiopathic Overactive Bladder (OAB) With Urge Incontinence and\u002For Urge-Predominant Mixed Incontinence","DENARA","INCLUSION CRITERIA:\n\n* Female, aged 22 to 80 years inclusive at the time of consent.\n* History of idiopathic overactive bladder (OAB) symptoms for ≥6 months.\n* At least 7 episodes of urge urinary incontinence (UUI) over 3 days, as recorded in a 3-day bladder diary during screening.\n* Urge-predominant incontinence, defined as greater number of UUI episodes than stress urinary incontinence (SUI) episodes during screening.\n* Willing and able to complete the 3-day bladder diary.\n* Willing to discontinue OAB medications (e.g., anticholinergics, beta-3 agonists) at least 2 weeks prior to baseline treatment visit, if currently taking such medications.\n* Willing to use a reliable method of contraception during the study period, if of childbearing potential and sexually active.\n* Negative pregnancy test at screening (if applicable).\n* Willing and able to provide written informed consent and comply with study procedures and follow-up schedule.\n\nEXCLUSION CRITERIA:\n\n* Predominant stress urinary incontinence (SUI) based on bladder diary\n* Currently pregnant, breastfeeding, or planning pregnancy during the study\n* History of neurologic conditions affecting bladder function (e.g., multiple sclerosis, spinal cord injury, Parkinson's disease)\n* Active urinary tract infection (UTI) at screening\n* History of interstitial cystitis, bladder pain syndrome, or chronic pelvic pain\n* Prior or current bladder cancer, pelvic malignancy, or pelvic radiation\n* Pelvic organ prolapse beyond the hymen (POP-Q stage \\> II)\n* Implanted neuromodulation device or prior sacral nerve stimulation\n* Use of bulking agents, Botox, or surgical treatment for incontinence within 12 months\n* Prior pelvic floor RF treatment or laser vaginal rejuvenation\n* Significant pelvic anatomical abnormalities that interfere with treatment\n* Use of investigational drug or device within 30 days before screening\n* Any condition that, in the investigator's opinion, would interfere with safe study participation or data integrity\n* Uncontrolled systemic disease (e.g., uncontrolled diabetes, cardiovascular disease)\n* Inability or unwillingness to comply with study requirements or follow-up",{"count":428,"type":21},202,[24],"The goal of this clinical trial is to learn if a vaginal radiofrequency (RF) device called MORPHEUSV works to treat overactive bladder (OAB) in women. Researchers also want to learn how safe the device is for this indication. This study will include women ages 22 to 80 who have had OAB symptoms for at least 6 months. The main questions it aims to answer are: Does the MORPHEUSV device lower the number of daily episodes of accidental urine leakage caused by urgency? Does it work better than a sham (placebo) treatment? Researchers will compare the MORPHEUSV device to a sham treatment to see how well it reduces symptoms of overactive bladder. Participants will: 1) Receive one session of either the MORPHEUSV or sham treatment. 2) Track their symptoms using a diary and questionnaires 3) Return for three to six follow-up visits over 12 months. This study is being conducted at multiple clinics in the United States.",[275,30,377,432,433,434,435],"Mixed Urinary Incontinence (Urge-Predominant)","Mixed Urinary Incontinence","Idiopathic Overactive Bladder With Urinary Incontinence","Idiopathic Overactive Bladder",[437,438,439,440,441,442],"Overactive bladder","Urge urinary incontinence","Mixed urinary incontinence","Female urinary symptoms","urogynecology","Female Urology","2026-01-28",{"date":445,"type":39},"2026-01-30",{"date":447,"type":39},"2025-11-25",{"date":449,"type":21},"2027-11-30",{"name":451,"class":46},"InMode MD Ltd.",9,{"id":454,"slug":455,"hasResults":12,"nctId":456,"briefTitle":457,"officialTitle":458,"acronym":4,"eligibilityCriteria":459,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":460,"targetDuration":4,"studyType":22,"phases":462,"briefSummary":463,"conditions":464,"keywords":465,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":469,"lastUpdatePostDateStruct":470,"startDateStruct":472,"completionDateStruct":473,"leadSponsor":475,"locationsCount":477},"100621467","early-detection-of-oab-and-elimination-of-negative-impact-on-quality-of-life-100621467","NCT07371000","Early Detection of OAB and Elimination of Negative Impact on Quality of Life","Early Detection of Overactive Bladder and Elimination of Negative Impact on Quality of Life","Inclusion criteria:\n\n* Signed Consent to Participate in the Project and Consent to the Processing of Personal Data (online and paper format)\n* Men and women over 18 years of age with increased urinary frequency (more than 7 times in 24 hours)\n\nOptional inclusion criteria:\n\n\\- Nycturia and\u002For urge incontinence.\n\nExclusion criteria:\n\n* Unsigned Consent to Participate in the Project and Consent to the Processing of Personal Data.\n* Current treatment of OAB, acute problems, suspicion of another disease causing OAB symptoms (haematuria, suspected bladder cancer, etc.)\n* Inflammation of the lower urinary tract.",{"count":461,"type":21},1000,[24],"Overactive bladder (OAB) is one of the most common health problems in the adult population. The goal of this project is to improve the awareness of the problem and to correctly refer the targeted persons to a specialist or a doctor. This will be provided by an online screening tool, designed as web platform and mobile application, where the data will be stored in respect to GDPR. People with a positive result from the online screening tool will be offered an examination by a specialist (gynaecologist, urogynaecologist, urologist) involved in the project. The specialist will have access to the results from the online screening tool - he\u002Fshe will log into the web platform with a view of the participants profile. He\u002Fshe will perform the diagnosis, confirm or refute the diagnosis and complement it with any further diagnostic tests and set the standard treatment.",[30],[437,466,467,468],"Screening","Telemedicine","Online screening tool","2026-01-22",{"date":471,"type":39},"2026-01-27",{"date":382,"type":39},{"date":474,"type":21},"2026-08-31",{"name":476,"class":331},"Institute of Health Information and Statistics of the Czech Republic",20,{"id":479,"slug":480,"hasResults":12,"nctId":481,"briefTitle":482,"officialTitle":482,"acronym":483,"eligibilityCriteria":484,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":485,"targetDuration":4,"studyType":22,"phases":487,"briefSummary":488,"conditions":489,"keywords":4,"overallStatus":150,"whyStopped":4,"lastUpdateSubmitDate":491,"lastUpdatePostDateStruct":492,"startDateStruct":494,"completionDateStruct":496,"leadSponsor":498,"locationsCount":100},"100614403","efficacy-and-safety-of-7-millimeters-vaginal-radiofrequency-in-overactive-bladder-100614403","NCT07279142","Efficacy and Safety of 7 Millimeters Vaginal Radiofrequency in Overactive Bladder","HYPNOS","Inclusion Criteria:\n\n* age\\>18 years old\n* Subject is willing to provide Informed Consent, is geographically stable, understands the requirements for completing the bladder diary and is willing to comply with the required diary, follow-up visits, and testing schedules.\n* Urinary incontinence, predominant urgency incontinence, with moderate-severe overactive bladder, International Consultation on Incontinence Questionnaire - Overactibe Bladder Short Form (ICIQ-OABSS) score ≥6.\n* Ability and willingness to self-catheterize in case this is necessary.\n* With respect to their reproductive capacity must be post-menopausal or surgically sterile or willing to use a contraceptive method with a failure rate of less than 1% per year when used consistently and correctly from screening until the last follow up\n\nExclusion Criteria:\n\n* Pacemaker or internal defibrillator, or any other metallic or electronic implant anywhere in the body.\n* Any permanent implant or an injected chemical substance in the treatment area.\n* Superficial areas that have been injected with hyaluronic acid (HA)\u002Fcollagen\u002Ffat injections or other augmentation methods with bio-material during last 6 months.\n* Current or history of cancer, or current condition of any other type of cancer, or premalignant moles.\n* Severe concurrent conditions, such as cardiac disorders, sensory disturbances, epilepsy, uncontrolled hypertension, and liver or kidney diseases.\n* Pregnancy, the intention of pregnancy and nursing.\n* Impaired immune system due to immunosuppressive diseases such as Acquired Immunodeficency Syndrome (AIDS) and Human Immunodeficency Virus (HIV), autoimmune disorders, or use of immunosuppressive medications.\n* Patients with a history of diseases stimulated by heat, such as recurrent Herpes Simplex in the treatment area, may be treated only following a prophylactic regimen.\n* Poorly controlled endocrine disorders, such as diabetes or thyroid dysfunction and hormonal virilization.\n* Any active condition in the treatment area, such as sores, eczema, and rash.\n* History of vaginal disorders, keloids, abnormal wound healing.\n* History of bleeding coagulopathies or use of anticoagulants in the last 10 days, as per the practitioner's discretion.\n* Non-italian speakers\n* Severely impaired mobility or cognition\n* Spinal cord injury or advanced\u002Fsevere neurologic condition including Multiple Sclerosis, Parkinson's Disease\n* Repair of pelvic organ prolapse or incontinence procedure in the previous 6 months\n* Ongoing complications of prior anti-incontinence surgery\n* Received intravesical botulinum injection within the previous 12 months\n* History of an implanted nerve stimulator for incontinence\n* History of prior sling or vaginal mesh placement,\n* Previous diagnosis of interstitial cystitis, bladder cancer, or chronic pelvic pain\n* Current participation in any other conflicting interventional or OAB treatment study\n* Planning to become pregnant during the study period.\n* Pelvic radiation, history of pelvic radiation\n* Active urinary tract or vaginal infection\n* Anatomical conditions that would prevent the introduction and use of the device, in such as significant pelvic organ prolapse,\n* Current hydronephrosis or hydroureter\n* Bladder outflow obstruction\n* Active pelvic organ malignancy\n* Urethral obstruction\n* Urinary retention or prolonged catheter use\n* Less than 12 months post-partum or currently pregnant or plan to become pregnant in the following 12 months.\n* Untreated symptomatic urinary tract infection\n* Unevaluated hematuria\n* Medical instability\n* Allergy to anesthetics as Benzocaine\u002FLidocaine\u002FTetracaine Cream (BLT Cream) used in the study\n* Not available for follow-up in 6 months\n* Participation in other research trials that could influence results of this study",{"count":486,"type":21},48,[24],"The investigator hypothesizes that controlled delivery of low heat (45-50 Centigrade) to the sub-detrusor and detrusor muscle can ablate the autonomic nerve endings and control overactive bladder symptoms without causing significant damage to the surrounding structures. Low heat in such a manner is below urethral sensation and enables office treatment. The transvaginal approach is non-invasive and improves overactive bladder (OAB) symptoms and patients' quality of life. The investigator believes that the RF administration results could be equal or better for first-line treated patients compared to pharmacological refractory patients.",[30,490],"Incontinence, Urge","2025-12-10",{"date":493,"type":39},"2025-12-12",{"date":495,"type":21},"2025-12-16",{"date":497,"type":21},"2026-12-24",{"name":499,"class":99},"IRCCS San Raffaele",{"id":501,"slug":502,"hasResults":12,"nctId":503,"briefTitle":504,"officialTitle":504,"acronym":505,"eligibilityCriteria":506,"healthyVolunteers":12,"sex":17,"minAge":507,"maxAge":508,"enrollmentInfo":509,"targetDuration":4,"studyType":22,"phases":511,"briefSummary":512,"conditions":513,"keywords":516,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":519,"lastUpdatePostDateStruct":520,"startDateStruct":522,"completionDateStruct":524,"leadSponsor":526,"locationsCount":100},"100595311","comparative-study-of-the-efficacy-of-treatment-of-idiopathic-overactive-bladder-oab-in-children-oxybutynine-vs-transcutaneous-neurostimulation-100595311","NCT07030803","Comparative Study of the Efficacy of Treatment of Idiopathic Overactive Bladder (OAB) in Children: Oxybutynine vs. Transcutaneous Neurostimulation","HAV-O-TENS","Inclusion Criteria:\n\n* Patients aged 6 to 16 years\n* Showing signs of OAB (pollakiuria (\\> 8 micturitions\u002Fd and\u002For urgenturia(\\>x2\u002Fweek) and\u002For daytime urine leakage (1\u002Fd) and\u002For nocturia x2\u002Fnight)\n* No treatment for more than 3 months\n* Urotherapy rules followed for at least 1 month\n* Beneficiary of a social security plan\n* Signature of consent by parents\u002Flegal guardian(s) and child's agreement\n\nExclusion Criteria:\n\n* Neurological cause of bladder dysfunction,\n* History of pelvic surgery,\n* Significant post-micturition residual (\\> 10% of micturition),\n* Recurrent urinary tract infections (\\> 3) in the 6 months prior to inclusion or urinary tract infection at inclusion.\n* Pregnant or breast-feeding adolescents\n* Severe constipation resistant to treatment (Rome IV),\n* Contraindication to oxybutynin\n* Contraindication to the use of TENS (Urostim)","6 Years","16 Years",{"count":510,"type":21},124,[24],"The absence of infectious, urological and neurological causes defines the idiopathic character of overactive bladder (OAB). Although a progressive approach starting with behavioural therapy (urotherapy) is recommended, anticholinergic agents remain the mainstay of medical treatment of overactive bladder (OAB) in children. Bladder neuromodulation is also used but no study with sufficient evidence has assessed its effectiveness and tolerance compared to the reference treatment. The purpose of HAV-O-TENS is to demonstrate the non-inferiority of treating idiopathic overactive bladder (OAB) in children using posterior tibial nerve stimulation (PTNS) compared to the reference treatment with oxybutynin after three months of treatment.\n\nBefore inclusion, patients will receive instructions for urotherapy and a treatment plan. After confirming the diagnosis and obtaining informed consent, patients will be randomly assigned to either oxybutynin or PTNS (posterior tibial nerve stimulation) treatment, and their effectiveness, tolerance, and adherence will be monitored.",[30,514,515],"Transcutaneous Neurostimulation","Posterior Tibial Nerve Stimulation",[275,517,518],"transcutaneous neurostimulation","posterior tibial nerve stimulation","2025-11-17",{"date":521,"type":39},"2025-11-18",{"date":523,"type":39},"2025-11-05",{"date":525,"type":21},"2029-03",{"name":527,"class":99},"Centre Hospitalier Universitaire, Amiens",{"id":529,"slug":530,"hasResults":12,"nctId":531,"briefTitle":532,"officialTitle":533,"acronym":534,"eligibilityCriteria":535,"healthyVolunteers":12,"sex":56,"minAge":268,"maxAge":4,"enrollmentInfo":536,"targetDuration":4,"studyType":22,"phases":538,"briefSummary":539,"conditions":540,"keywords":542,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":543,"lastUpdatePostDateStruct":544,"startDateStruct":546,"completionDateStruct":548,"leadSponsor":550,"locationsCount":188},"100577357","approve-trial-evaluating-a-prescription-digital-therapeutic-for-treatment-of-oab-in-women-100577357","NCT06797245","APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women","The APPROVE Trial: A Randomized Controlled Trial Evaluating the Efficacy and Safety of a Prescription Digital Therapeutic for Treatment of Overactive Bladder in Women","APPROVE","Inclusion Criteria:\n\n* Women ≥ 22 years old\n* Bothersome OAB symptoms (defined as bother rating ≥ 5 on ICIQ-FLUTS question #3b or #9b)\n* English-speaking\n* Willing to forego other treatment outside of medications for the 8-week trial period\n* Use of at least one mobile App\n\nExclusion Criteria:\n\n* Stress-predominant mixed urinary incontinence (defined as QUID stress score \\> QUID urge score)\n* Voiding dysfunction defined as response ≥ 2 on ICIQ-FLUTS question #7a\n* Bladder pain defined as response ≥ 2 on ICIQ-FLUTS question #4a\n* Use of an OAB medication (anticholinergic or beta-agonist) within the past two weeks\n* Currently using intermittent or indwelling catheter\n* History of bladder\u002Furethral, colon\u002Fanal, or cervical cancer\n* Current or prior use of sacral neuromodulation, tibial stimulation or onabotulinum toxin type A intradetrusor injection\n* Currently taking antibiotics\u002Fdrugs for urinary tract infection\\^\n* Currently undergoing or unwilling to forego pelvic floor physical therapy with a physical therapist or prescription device for the 8-week intervention period\n* Planning surgery for pelvic organ prolapse within 12 months of randomization\n* Pelvic surgery within the past 6 months\n* Planning to undergo pessary fitting °\n\n  * Those on antibiotics for urinary tract infection will be eligible for enrollment 2 weeks after completing antibiotic therapy with subjective resolution of UTI symptoms °Will be eligible after completing pessary fitting\n\nhttps:\u002F\u002Fresearchdata.medstar.net\u002Fredcap\u002Fsurveys\u002F?s=MM7WN7EXACX4PNXJ",{"count":537,"type":21},596,[24],"The APPROVE trial is a multi-centered, randomized controlled trial designed to assess differences in symptom improvement, quality of life, bladder symptoms, satisfaction with treatment and continued treatment efficacy in women with overactive bladder (OAB) randomized to a prescription digital therapeutic (PDTx) app called RiSolve compared to standard behavioral education (handouts).",[30,318,27,146,541],"Urinary Frequency",[30],"2025-10-24",{"date":545,"type":39},"2025-10-27",{"date":547,"type":39},"2025-03-17",{"date":549,"type":21},"2028-07",{"name":551,"class":99},"Medstar Health Research Institute",{"id":553,"slug":554,"hasResults":12,"nctId":555,"briefTitle":556,"officialTitle":557,"acronym":558,"eligibilityCriteria":559,"healthyVolunteers":12,"sex":56,"minAge":560,"maxAge":4,"enrollmentInfo":561,"targetDuration":4,"studyType":211,"phases":4,"briefSummary":562,"conditions":563,"keywords":564,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":566,"lastUpdatePostDateStruct":567,"startDateStruct":569,"completionDateStruct":571,"leadSponsor":573,"locationsCount":100},"100594868","assessing-the-genitourinary-microbiome-of-women-with-overactive-bladder-undergoing-onabotulinum-toxin-type-a-intradetrusor-injections-100594868","NCT07025044","Assessing the Genitourinary Microbiome of Women With Overactive Bladder Undergoing Onabotulinum Toxin Type A Intradetrusor Injections","Characterizing the Postmenopausal Genitourinary Microbiome in Women Undergoing Onabotulinum Toxin Type A for Overactive Bladder - A Feasibility Trial","MICROAB_Pilot","Inclusion Criteria:\n\n* Natal female \\> 55 years old\n* English-speaking\n* Scheduled to undergo onabotulinum toxin type A for treatment of OAB\n* No menses for \\>1 year if uterus in situ\n* Planning one dose nitrofurantoin for antibiotic prophylaxis at time of onabotulinum toxin type A injection per clinic protocol\n\nExclusion Criteria:\n\n* Diagnosis of painful bladder syndrome\n* Current symptomatic or clinically-suspected UTI within 30 days prior to onabotulinum toxin type A injection procedure\\*\n* Systemic antibiotic exposure within 30 days\\^\n* Prophylactic antibiotic treatment for recurrent UTI within the last 12 months\n* Current systemic immunosuppressive therapy (i.e. prednisone or immunomodulators) immunotherapy, chemotherapy or radiation treatment\n* Prior pelvic radiation\n* Indwelling catheter or intermittent catheterization","55 Years",{"count":294,"type":21},"Single-site prospective observational pilot feasibility study of women with overactive bladder\u002Furge urinary incontinence undergoing onabotulinum toxin type A intradetrusor injections in order to achieve the following objectives:\n\n* Establish a record of successful collaboration with Dr. Ravel, an expert researcher in the female microbiome based at the University of Maryland\n* Demonstrate the investigators' ability to recruit subjects from the diverse population of postmenopausal women undergoing BTX for OAB within MedStar Health Urogynecology clinics\n* Collect, process and analyze urine specimens collected prior to and 4-weeks after BTX injection, and to compare the GU microbiome of self-collected versus clinic-collected samples\n* Assess response to BTX treatment and explore rates of and risk factors for urinary tract infection and incomplete voiding requiring catheterization within the first 4-weeks after BTX",[30,345],[565],"onabotulinum toxin type A","2025-09-08",{"date":568,"type":39},"2025-09-12",{"date":570,"type":39},"2025-09-03",{"date":572,"type":21},"2026-06-01",{"name":574,"class":99},"Alexis Dieter",{"id":576,"slug":577,"hasResults":12,"nctId":578,"briefTitle":579,"officialTitle":580,"acronym":581,"eligibilityCriteria":582,"healthyVolunteers":12,"sex":56,"minAge":18,"maxAge":4,"enrollmentInfo":583,"targetDuration":4,"studyType":22,"phases":585,"briefSummary":586,"conditions":587,"keywords":589,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":591,"lastUpdatePostDateStruct":592,"startDateStruct":594,"completionDateStruct":596,"leadSponsor":597,"locationsCount":100},"100599201","home-based-transcutaneous-remotely-monitored-posterior-tibial-neuromodulation-100599201","NCT07081412","Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation","Home-Based Transcutaneous Remotely Monitored Posterior Tibial Neuromodulation System in Overactive Bladder: A Randomized Controlled Trial","TRIP-HOME","Inclusion Criteria:\n\n1. Patients who are ≥18 years old and female patients diagnosed with OAB\\* in Urology or Urogynecology outpatient clinics and who meet the inclusion criteria\n2. Being able to continue their T-PTNS\\*\\* treatment at home with the mobile application and accepting this,\n3. Having a smartphone compatible with the application for T-PTNS and being able to use the application\n4. Agreeing to be followed up for one year after treatment,\n5. Having stopped all antimuscarinics for at least two weeks,\n6. Being able to stand and use the toilet independently without difficulty,\n7. Volunteers who are willing to participate, have been informed about the study and have given signed informed consent, stating that they can comply with the requirements and restrictions listed in the informed consent form (ICP) and this protocol.\n\nExclusion Criteria:\n\n1. Patients under the age of 18\n2. Patients who are pregnant according to the results of a pregnancy test with urine or blood test, or who are planning a pregnancy during the study period, or who are breastfeeding\n3. Patients diagnosed with neurogenic bladder\n4. Patients with Dabetes Mellitus whose blood sugar cannot be controlled\n5. Patients with a history of allergic reactions on the skin\n6. Cases with prolapse greater than Stage-2 according to the POP-Q staging system and extending beyond the hymen\n7. Cases with a PVR evaluation of 100 ml and above with USG\n8. Contraindications for T-PTNS treatment (patients with pacemakers, implantable defibrillators or metal prostheses\n9. Patients with urinary tract infection\\*\n10. Having had botox applied to the bladder or pelvic floor muscles within the last year\n11. Having had a previous surgery related to the pelvic floor\n12. Current TENS use in the pelvic region, back or legs\n13. Having received PTNS treatment before\n14. Use of Interstim or Bion\n15. Those who do not accept the treatment or follow-up to be performed\n16. Those who may have problems complying with the requirements of the study plan\n17. Negative benefit\u002Frisk ratio determined by the investigator\n18. Those who have been included in any other clinical trial or use of investigational drug\u002Fdevice therapy within 30 days before the study visit",{"count":584,"type":21},50,[24],"To record the T-PTNS device (SmartUric) treatment performed by the patient at home via a mobile application in a remotely monitorable, secure and interactive manner with registration notes and a sham control group.",[214,30,588],"Transcutaneous Posterior Tibial Nerve Stimulation (TTNS)",[88,64,515,590],"Quality of Life","2025-07-22",{"date":593,"type":39},"2025-07-23",{"date":595,"type":39},"2025-06-24",{"date":198,"type":21},{"name":598,"class":99},"Ege University",{"id":600,"slug":601,"hasResults":12,"nctId":602,"briefTitle":603,"officialTitle":604,"acronym":4,"eligibilityCriteria":605,"healthyVolunteers":12,"sex":56,"minAge":606,"maxAge":80,"enrollmentInfo":607,"targetDuration":4,"studyType":22,"phases":608,"briefSummary":609,"conditions":610,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":611,"lastUpdatePostDateStruct":612,"startDateStruct":614,"completionDateStruct":616,"leadSponsor":618,"locationsCount":100},"100594914","comparing-treatments-for-overactive-bladder-in-taiwan-a-study-of-outcomes-100594914","NCT07025642","Comparing Treatments for Overactive Bladder in Taiwan: A Study of Outcomes","Outcome of Different Treatments of Overactive Bladder in Taiwan","Inclusion Criteria:\n\n\\- female overactive bladder\n\nExclusion Criteria:\n\n* DM, CVA, other medical problems","30 Years",{"count":270,"type":21},[24],"Overactive bladder (OAB) syndrome is a prevalent condition that significantly impairs patients' quality of life. Standard therapeutic strategies include oral antimuscarinics (e.g., solifenacin), beta-3 adrenergic agonists (e.g., mirabegron), and intradetrusor injection of botulinum neurotoxin type A (BoNTA). Despite their clinical utility, these treatments share a common mechanism of action: suppression of detrusor muscle contractility. However, it remains unclear whether such suppression translates to a reduction in the overall mechanical work output of the bladder during micturition.\n\nTo address this question, our research proposes to assess how mirabegron, solifenacin, and BoNTA influence bladder function from a thermodynamic perspective. We will apply pressure-volume analysis (PVA), a methodology traditionally used in cardiac physiology, to quantify the mechanical work performed by the bladder per voiding cycle. This approach enables a direct measurement of the energy expenditure required for bladder emptying, offering insights beyond standard urodynamic parameters.\n\nFurthermore, emerging data suggest BoNTA may exert additional effects beyond parasympathetic inhibition. Specifically, recent studies have demonstrated that BoNTA also inhibits norepinephrine release from sympathetic hypogastric nerve terminals. Since modulation of sympathetic activity-particularly via the hypogastric nerve-has been implicated in regulating bladder compliance and storage function, we hypothesize that BoNTA may influence bladder compliance through this secondary mechanism. To explore this, we will employ volume-pressure analysis (also abbreviated as PVA), which graphically represents the dynamic relationship between bladder volume and pressure throughout voiding cycles, thus capturing real-time changes in compliance.\n\nComparative studies of mirabegron, solifenacin, and BoNTA will allow us to differentiate their respective impacts on bladder work and compliance. Mirabegron, which selectively activates beta-3 adrenergic receptors, has minimal influence on overall sympathetic tone. In contrast, solifenacin not only antagonizes muscarinic receptors but may also indirectly potentiate sympathetic tone by reducing parasympathetic influence. BoNTA, with its dual action on both autonomic pathways, provides a unique model to dissect these neural mechanisms.\n\nTo extend our findings from clinical observations to preclinical validation, we aim to develop and utilize a spinal cord injury (SCI) rat model that recapitulates the bladder dysfunction observed in neurogenic detrusor overactivity (NDO)-a condition for which mirabegron, solifenacin, and BoNTA are also commonly prescribed. By applying both thermodynamic and compliance-focused PVA techniques in this animal model, we seek to construct a foundational database characterizing how these drugs modulate bladder function in a controlled, reproducible setting.\n\nIn summary, this project integrates a novel application of pressure- and volume-based analyses to quantify the mechanical and compliance-related effects of established OAB therapies in both human patients and a translational animal model. The findings will provide new mechanistic insights into how these treatments alter bladder physiology, potentially guiding future therapeutic strategies and optimizing drug selection for individualized patient care.",[30],"2025-06-13",{"date":613,"type":39},"2025-06-17",{"date":615,"type":21},"2025-07-01",{"date":617,"type":21},"2026-12-01",{"name":619,"class":99},"Mackay Medical College"]