[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"urinary-incontinence-urge\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:urinary-incontinence-urge":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,41,70,100,132,171,192,213],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":17,"targetDuration":4,"studyType":20,"phases":4,"briefSummary":21,"conditions":22,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100541933","nxt-post-market-clinical-follow-up-100541933",false,"NCT06336304","NXT Post-Market Clinical Follow-up","NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation","Inclusion Criteria:\n\n* Patients medically indicated for urodynamic study\n* Patient or legally authorized representative provides written authorization and\u002For consent per institution and geographical requirements\n\nExclusion Criteria:\n\n* Patients or legally authorized representative with cognitive or psychiatric condition that interferes with or precludes direct and accurate communication regarding the study, giving informed consent or ability to complete the patient questionnaire\n* Patients with confirmed active bladder infections (not including patients with asymptotic bacteria)\n* Pregnant women\n* Patients with recent (less than 2 weeks) pelvic floor surgery\n* Requires use of suprapubic catheter","ALL",{"count":18,"type":19},180,"ESTIMATED","OBSERVATIONAL","NXT Urodynamics System Post-Market Clinical Follow-up Clinical Investigation to Confirm Ongoing Safety and Performance in Urodynamic Patient Sub-Populations",[23,24,25,26,27],"Urinary Incontinence","Urinary Obstruction","Urinary Bladder, Overactive","Urinary Bladder, Neurogenic","Urinary Incontinence, Urge","RECRUITING","2026-05-13",{"date":31,"type":32},"2026-05-15","ACTUAL",{"date":34,"type":32},"2024-06-18",{"date":36,"type":19},"2027-03",{"name":38,"class":39},"Laborie Medical Technologies Inc.","INDUSTRY",5,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":4,"eligibilityCriteria":47,"healthyVolunteers":11,"sex":16,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":51,"phases":52,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":69},"100531531","vitamin-d-treat-to-target-strategy-for-children-with-overactive-bladder-wet-100531531","NCT06201013","Vitamin D Treat-to-Target Strategy for Children With Overactive Bladder-Wet","Efficacy, Neural Repair Mechanism, and Health Economics of a Multimodal Treat-to-Target Strategy Incorporating Vitamin D for Pediatric Overactive Bladder-Wet: A Randomized Controlled Trial","Inclusion Criteria:\n\n* Children older than or equal to 5 years of age with a diagnosis of wet OAB (the diagnosis followed the latest guidelines of ICCS) attending the outpatient clinic of the Department of Urology of the Affiliated Children's Hospital of Chongqing Medical University,\n* children with serum vitamin D levels below 35 ng\u002Fml as indicated by the tests conducted by the hospital\n* children whose guardians have given their informed consent, are able to ensure compliance and have signed a paper-based informed consent form.\n\nExclusion Criteria:\n\n* Those with urinary malformations or serious diseases (e.g., hypospadias, cryptorchidism, posterior urethral valvulae, vesicoureteral reflux, neurogenic bladder, urinary tumors, urinary stones, bladder and urethral injuries, etc.)\n* Those with neurological disorders (e.g., epilepsy, spinal cord injuries, spinal dysplasia, spinal embolism syndrome, multiple sclerosis, and autism spectrum disorders, etc.)\n* People with serious heart disease, abnormal liver and kidney function, lung disease, bone deformity, serious digestive tract disease, genetic metabolic disease\n* People with history of gastrointestinal surgery and urological surgery\n* People with dry stools and long-term constipation\n* People who are taking anticonvulsant and antiepileptic drugs, hormones, and anti-tuberculosis drugs\n* People with history of hypercalcemia, hyperphosphatemia with renal rickets\n* People who have had unexplained hematuria and hematuria with renal rickets within the last year\n* People who have been suffering from severe heart disease or chronic diabetes.\n* participation in other clinical studies at the time of consultation or during the follow-up period of other clinical studies\n* unwillingness to participate in this study","5 Years","18 Years",{"count":18,"type":19},"INTERVENTIONAL",[53],"NA","The purpose of this clinical trial is to investigate whether adding high-dose vitamin D (2,400 IU daily) to standard medical treatment (solifenacin combined with behavioral therapy) is more effective than standard treatment alone for children with overactive bladder-wet (OAB-wet).\n\nOAB-wet causes sudden urinary urges and frequent daytime or incontinence, which significantly impacts a child's quality of life and increases the family's caregiving burden. While solifenacin is a standard medication used to calm the bladder, many children do not achieve complete dryness. This study introduces the \"Treat-to-Target\" (T2T) approach, where clinicians and families set personalized \"functional goals\" (such as zero leakage) and monitor progress closely to adjust care.\n\nThe study aims to answer the following questions:\n\nDoes adding vitamin D help more children achieve their goal of \"zero leakage\" compared to standard treatment? Does vitamin D help repair bladder-related nerves, as measured by a specific marker in the urine? Does this combined approach reduce the family's expenses (like laundry costs and diaper use) and improve the child's self-esteem?\n\nParticipants will be randomly assigned to one of two groups for 12 weeks:\n\nIntervention Group: Standard care (solifenacin + behavioral therapy) plus daily vitamin D (2,400 IU).\n\nControl Group: Standard care (solifenacin + behavioral therapy) alone. Researchers will evaluate symptoms, vitamin D levels, and nerve repair markers at 6 and 12 weeks to determine the best treatment strategy for these children.",[25,56,27],"Overactive Bladder",[25,27,58],"Vitamin D","2026-04-14",{"date":61,"type":32},"2026-04-17",{"date":63,"type":19},"2026-04-20",{"date":65,"type":19},"2027-04-15",{"name":67,"class":68},"Children's Hospital of Chongqing Medical University","OTHER",1,{"id":71,"slug":72,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":78,"sex":79,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":51,"phases":83,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100467095","phase-4-treating-incontinence-for-underlying-mental-and-physical-health-100467095","NCT05362292","TReating Incontinence for Underlying Mental and Physical Health","Cognitive, Urinary, and Functional Trajectories of Older Women Using Pharmacologic Treatment Strategies for Urgency Incontinence","TRIUMPH","Inclusion Criteria:\n\n* Aged 60 years or older at the time of enrollment\n* Female sex at birth, without surgical or hormonal gender re-assignment therapy\n* Able to walk to the bathroom and use the toilet without assistance\n* Report urinary incontinence starting at least 3 months prior to screening\n* Report that at least half of incontinence episodes occur with a sudden or strong sensation of urgency\n* Report 2 or more urgency incontinence episodes over a 7-day period\n* Willing to provide informed consent and adhere to study procedures throughout the length of the study\n\nExclusion Criteria:\n\n* Prior clinician diagnosis of dementia, or a Montreal Cognitive Assessment (MOCA) score of 17 or lower on screening cognitive evaluation\n* Current use of anticholinergic, beta-3-adrenergic agonist, or other medication designed to improve urgency incontinence symptoms, or use in the past 1 month\n* Initiation, discontinuation, or dose change of dementia medications (such as donepezil, galantamine, memantine, rivastigmine) in the past 1 month (but candidates on stable doses are eligible)\n* Initiation, discontinuation, or dose change of other drugs with strong anticholinergic effects (based on the Beers List) in the past 1 month (but candidates on stable doses are eligible)\n* Initiation, discontinuation, or dose change of other drugs that can affect urinary frequency, including diuretics, in the past 1 month (but candidates on stable doses are eligible)\n* Current urinary tract infection (UTI) based on screening urinalysis and culture (but candidates can re-present for re-screening after undergoing treatment for UTI)\n* History of allergy or sensitivity to either of the study medications or an ingredient in the placebo or study medication capsule\n* Severe hepatic impairment (Child-Pugh score B or greater) or renal impairment (creatinine clearance \\\u003C30 mL\u002Fmin) as a contraindication to both study medications\n* Current bladder obstruction or urinary retention (defined by symptoms suggesting difficulty emptying the bladder in addition to postvoid residual urine volume greater than 150 cc by portable bladder ultrasound)\n* Uncontrolled hypertension (based on measured systolic blood pressure greater than 180 or diastolic blood pressure greater than 110 mmHg) as a contraindication to beta-3-adrenergic therapy\n* Self-reported history of gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe ulcerative colitis, or toxic megacolon as contraindications for anticholinergic bladder therapy\n* Use of drugs with adverse interactions with one of the study medications in the past 1 month, including potent CYP3A4 inhibitors, hepatic enzyme metabolism inducers, narrow therapeutic index drugs metabolized by CYP2D6, or intention to start taking one of these medications during the study treatment period\n* History of bladder surgery, invasive intra-vesical therapy, or bulk bladder injections in the past 3 months (more remote surgery will not be exclusionary), or intention to undergo one of these procedures in the study treatment period\n* Use of other specialized incontinence therapy (electrostimulation, pelvic physiotherapy, formal behavioral therapy overseen by certified practitioners) in the past 3 months (more remote therapy will not be exclusionary), or intention to undergo one of these procedures in the study treatment period\n* Inability to sign informed consent or complete questionnaires, interviews, or study testing in English\n* Other condition that would prevent the participant from completing study procedures, in the opinion of the investigators (e.g., uncontrolled psychosis)",true,"FEMALE","60 Years",{"count":82,"type":19},270,[84],"PHASE4","The TRIUMPH study is a randomized, double-blinded, 3-arm, parallel-group trial designed to compare the effects of anticholinergic bladder therapy versus a) beta-3-adrenergic agonist bladder therapy and b) no bladder pharmacotherapy on cognitive, urinary, and other aging-related functional outcomes in ambulatory older women with urgency-predominant urinary incontinence and either normal or mildly impaired cognitive function at baseline.",[27,23,56,87,88,89],"Incontinence, Urge","Incontinence, Urinary","Incontinence","2026-03-04",{"date":92,"type":32},"2026-03-06",{"date":94,"type":32},"2022-10-04",{"date":96,"type":19},"2027-08-02",{"name":98,"class":68},"University of California, San Francisco",2,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":79,"minAge":49,"maxAge":4,"enrollmentInfo":107,"targetDuration":4,"studyType":51,"phases":109,"briefSummary":110,"conditions":111,"keywords":118,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":131},"100523126","safety-and-performance-of-ucon-bar-electrode-for-the-treatment-of-overactive-bladder-oab-and-bowel-dysfunction-bd-100523126","NCT06091566","Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD)","Safety and Performance of UCon Bar Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - An Early Feasibility Study","Inclusion Criteria:\n\n1. Participant is female\n2. Participant is ≥ 18 years of age.\n3. Participant is diagnosed with OAB or BD.\n\n   OAB: Urinary urgency usually with one or more of the following:\n\n   i. Urinary urgency incontinence (≥1 per\u002Fweek). ii. Urinary frequency (≥8 voiding\u002Fday without polyuria). iii. Nocturia (≥2 voiding\u002Fnight without nocturnal polyuria).\n\n   BD: One or more of the following:\n\n   i. Faecal urgency (≥3 urgencies pr. week) together with registration of urgency in St. Mark´s and a St. Mark´s score ≥9.\n\n   ii. Faecal incontinence (urge\u002Fpassive) (≥1 per\u002Fweek).\n4. Participant is able to communicate, provide feedback, understand and follow instructions during the course of the investigation, including using the device at home.\n\nExclusion Criteria:\n\n1. Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participants´ participation in the investigation).\n2. Participant has an active infection in the genital area.\n3. Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).\n4. Participant is pregnant, nursing or planning a pregnancy (to be confirmed with a negative pregnancy test). Women of childbearing potential must maintain effective contraception during the clinical investigation.\n5. Participant is enrolled or planning to enrol in another conflicting clinical investigation or was enrolled in an investigational drug trial or medical device investigation within four weeks of enrolment.\n6. Participant has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.\n7. Participant has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has received radiation therapy in the pelvic region.\n8. Participant has addictive behaviour defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.\n9. Participant does not speak or understand Danish.\n\n   * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.",{"count":108,"type":19},20,[53],"UCon is a medical device for treatment of the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder\u002Fbowel musculature e.g., suppress undesired bladder\u002Fbowel activity to relieve the symptoms of the patient.\n\nThis clinical investigation is designed as a single-arm, prospective, multi-centre, and early feasibility study.",[23,27,112,113,114,115,116,117],"Fecal Incontinence","Fecal Incontinence With Fecal Urgency","Nocturia","Urinary Frequency More Than Once at Night","Bowel Disorders Functional","Incontinence, Nighttime Urinary",[23,112,119,120,121],"Urge incontinence","Neurostimulation","Dorsal Genital Nerve","2026-02-16",{"date":124,"type":32},"2026-02-18",{"date":126,"type":32},"2024-01-12",{"date":128,"type":19},"2027-01-01",{"name":130,"class":39},"InnoCon Medical",3,{"id":133,"slug":134,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":11,"sex":79,"minAge":49,"maxAge":4,"enrollmentInfo":139,"targetDuration":4,"studyType":51,"phases":141,"briefSummary":142,"conditions":143,"keywords":149,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":162,"lastUpdatePostDateStruct":163,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":99},"100622722","phase-4-a-randomized-placebo-controlled-trial-of-nitrous-oxide-during-in-office-bladder-botox-injections-100622722","NCT07387315","A Randomized, Placebo-controlled Trial of Nitrous Oxide During In-office Bladder Botox Injections","A Randomized, Placebo Controlled Trial of Nitrous Oxide\u002FOxygen Plus Standard Care Versus Standard Care Alone During In-office Intradetrusor onabotulinumtoxinA (Botox) Injections","Inclusion Criteria:\n\n* Adult women ≥18 years old scheduled for in-office intradetrusor botulinum toxin injection and able to consent.\n\nExclusion Criteria:\n\n* Known\u002Fsuspected vitamin B12 or folate deficiency or high-risk state (e.g., pernicious anemia, malabsorption, post-bariatric or strict vegan without supplementation)\n* currently pregnant\n* severe\u002Funstable pulmonary disease or baseline hypoxemia requiring supplemental home oxygen\n* eye or ear surgery in the last six weeks\n* trapped-air conditions (e.g., untreated pneumothorax, bowel obstruction)\n* severe active otitis\u002Fsinus disease\n* inability to follow directions\n* history of adverse reaction to nitrous oxide",{"count":140,"type":19},96,[84],"The goal of this clinical trial is to assess if a mix of nitrous oxide and oxygen can improve pain control during bladder Botox injections. The primary question it aims to answer is: Does using nitrous oxide lower the overall level of pain during the procedure?\n\nResearchers will compare a 50:50 nitrous oxide\u002Foxygen mixture (administered with the Pro-Nox system) plus standard care (with lidocaine in the bladder) to sham mask plus standard care to see if nitrous oxide works better for lowering pain.\n\nParticipants will:\n\n* Receive their bladder Botox injection in the office setting\n* Either use nitrous oxide\u002Foxygen plus standard care during the procedure, or sham mask plus standard care\n* Answer brief questions about pain, anxiety, satisfaction, and willingness to repeat the procedure",[56,144,145,146,23,25,26,147,27,148],"Neurogenic Bladder","Urge Incontinence","Pain","Urinary Bladder Neurogenesis","Pelvic Floor Disorders",[56,23,145,150,151,152,153,154,155,156,157,158,159,160],"Intradetrusor Injection","OnabotulinumtoxinA","Botox","Bladder Botox","Botulinum Toxins, Type A","Pain Management","Analgesia","Nitrous Oxide","Office-based Procedures","Urogynecology","Pelvic Floor Disorder","NOT_YET_RECRUITING","2026-01-28",{"date":164,"type":32},"2026-02-04",{"date":166,"type":19},"2026-02",{"date":168,"type":19},"2026-12",{"name":170,"class":68},"TriHealth Inc.",{"id":172,"slug":173,"hasResults":11,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":11,"sex":178,"minAge":49,"maxAge":4,"enrollmentInfo":179,"targetDuration":4,"studyType":51,"phases":180,"briefSummary":181,"conditions":182,"keywords":183,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":184,"lastUpdatePostDateStruct":185,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":69},"100506437","ucon-treatment-of-overactive-bladder-oab-in-males-100506437","NCT05874375","UCon Treatment of Overactive Bladder (OAB) in Males","Safety and Performance of UCon for Management of Non-Neurogenic OAB in Males - An Early Feasibility Study","Inclusion Criteria:\n\n1. Subject is ≥ 18 years of age.\n2. Subject is male.\n3. Subject is diagnosed with OAB\n4. Subject is able to communicate, provide feedback, understand and follow instructions during the course of the investigation.\n\nExclusion Criteria:\n\n1. Subject is medically unstable (acute illness or complications of a chronic condition that might affect the subject's participation in the investigation).\n2. Subject has a Post Void Residual (PVR) of more than 100 ml or a Bladder Voiding Efficiency (BVE) of less than 75% (measured by uroflowmetry as the ratio of voided volume (VV) and total bladder capacity (VV+PVR)).\n3. Subject has an active infection in the genital area incl. skin infections and urinary tract infection.\n4. Subject has had botulinum toxin (BOTOX) treatment in the pelvic region within 6 months.\n5. Subject has used antimuscarinics or β3 agonists within 14 days weeks\\*.\n6. Subject has an implanted pacemaker, implantable drug pump or other active medical device (any medical device that uses electrical energy or other source of power to make it function).\n7. Subject is enrolled or planning to enrol in another clinical investigation or was enrolled in an investigational drug study or medical device investigation within four weeks to enrolment.\n8. Subject has neuropathy to a degree that is presumed to diminish the effect of the electrical stimulation.\n9. Subject has a history of cancer in the pelvic region, are currently receiving cancer treatment, or has radiation-induced damage to the pelvic region.\n10. Subject has addictive behaviour defined as abuse of alcohol, cannabis, opioids, or other intoxicating drugs.\n11. Subject does not speak and understand Dutch.\n\n    * If a subject is currently being treated with antimuscarinics or β3 agonists, he is allowed to be included in the investigation, however, a washout period of 14 days is required before baseline can be established.","MALE",{"count":108,"type":19},[53],"UCon is a medical device for treatment of the symptoms of OAB and fecal incontinence (FI). It electrically stimulates the DGN through the skin to obtain modulated behaviour of the bladder musculature e.g., suppress undesired bladder activity to relieve the symptoms of the patient. This clinical investigation is a randomized, cross-over, single-site, prospective, early feasibility study, which is used to evaluate Ucon with respect to its initial clinical safety and device performance in a small number of males with OAB.",[23,145,114,115,27,117],[23,119,120,121,114],"2025-09-30",{"date":186,"type":32},"2025-10-01",{"date":188,"type":32},"2023-10-12",{"date":190,"type":19},"2026-06-12",{"name":130,"class":39},{"id":193,"slug":194,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":4,"eligibilityCriteria":198,"healthyVolunteers":11,"sex":16,"minAge":49,"maxAge":4,"enrollmentInfo":199,"targetDuration":4,"studyType":51,"phases":200,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":205,"lastUpdatePostDateStruct":206,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":131},"100574046","safety-and-performance-of-ucon-patch-electrode-100574046","NCT06754189","Safety and Performance of UCon Patch Electrode","Safety and Performance of UCon Patch Electrode for the Treatment of Overactive Bladder (OAB) and Bowel Dysfunction (BD) - A Pivotal Clinical Investigation","Inclusion Criteria:\n\n* Participant is ≥ 18 years of age.\n* Participant is diagnosed with OAB or BD.\n* Participant is able to consent, communicate, provide feedback, and understand and follow instructions in Danish during the course of the investigation, including operation of the device at home.\n\nExclusion Criteria:\n\n* Participant has genital anatomy that does not allow for proper electrode placement or stimulation of the DGN.\n* Participant has an active infection in the genital area, including skin infections.\n* Participant has injured or irritated skin in the genital area, where the electrode is placed.\n* Participant is medically unstable (acute illness or complication of a chronic condition, apart from the OAB or BD, that might affect the participant's participation in the investigation).\n* Participant has an implanted pacemaker, implantable drug pump or other active medical devices (any medical device that uses electrical energy or other sources of power to make it function).\n* Participant is pregnant, nursing, planning a pregnancy (to be confirmed with a negative pregnancy test) or has given birth within the previous 12 months. Women of childbearing potential must maintain effective contraception\\* during the clinical investigation.\n* Participant is enrolled or planning to enroll in another conflicting clinical investigation or was enrolled in an investigational drug trial within the previous 12 weeks or medical device investigation within 12 weeks of enrolment.\n* Participant has previously participated in a clinical investigation with UCon.\n* Participant has failed (lack of effectiveness) other neuromodulation treatments, e.g. sacral neuromodulation (SNM) within the previous 2 years.\n* Participant has a neurological disease, e.g., chronic inflammatory demyelinating polyneuropathy, multiple sclerosis, stroke, central nervous system (CNS) tumors, Parkinson´s, spinal cord injury, diabetic neuropathy, Guillain-Barré syndrome.\n* Participant has a history of cancer in the pelvic region, is currently receiving cancer treatment, or has received radiation therapy in the pelvic region.\n* Participant had surgery in the pelvic region within the previous 6 months. If it can be excluded that the participant's symptoms are related to the surgery, they can be included in the clinical investigation.\n* Participant has addictive behavior defined as the abuse of alcohol, cannabis, opioids, or other intoxicating drugs.\n\n  * The following contraception is considered effective: Intrauterine device, hormonal contraceptives such as birth control pills, implants, contraceptive patch, vaginal ring, and contraceptive injection.\n\nExclusion Criteria specific for OAB:\n\n* Participant is planning or has a scheduled surgery\u002Fdiagnostic procedure (within the duration of their participation) for any condition, that would require catheterization. Or have a prolonged hospitalization that would affect the ability to complete the stimulation.\n* Participant (male) has symptoms of bladder outlet obstruction, e.g., caused by benign prostatic hyperplasia or prostate cancer.\n* Participant has polyuria or symptoms of polyuria.\n* Participant has a current or reoccurring urinary tract infection (≥3 or more within the previous 12 months or ≥2 within the previous 6 months).\n* Participant has a primary diagnosis of stress urinary incontinence (SUI) or mixed incontinence with SUI likely to confound outcome measures.\n* Participant has Bladder Pain Syndrome or interstitial cystitis.\n* Participant has had botulinum toxin (BOTOX) treatment in the pelvic region within 9 months or has lasting benefit from BOTOX.\n* Participant has failed (lack of effectiveness) BOTOX treatment within the previous 2 years.\n* Participants who demonstrate detrusor overactivity on a urodynamic test can be included.\n* Participant has used antimuscarinics or β3 agonists within 2 weeks.\n* Participant has started oestrogen therapy within 3 months or are planning to stop therapy when enrolled in the clinical investigation.\n\nExclusion Criteria specific for BD:\n\n* Participant is planning or has a scheduled surgery\u002Fdiagnostic procedure (within the duration of their participation), for any condition, that would influence their bowel movements (e.g., injection of bulking agents, radiofrequency energy, or ligation of haemorrhoids). Or have a prolonged hospitalization that would affect the ability to complete the stimulation.\n* Participant is currently being treated with antibiotics.\n* Participant has a history of uncontrolled diarrhoea in the past 3 months (usual or most common stool type over the preceding 3 months of 7 on the Bristol Stool Form Scale).\n* Participant has a history of severe constipation in the past 3 months (usual or most common stool type over the preceding 3 months of 1 on the Bristol Stool Form Scale).\n* Participant has a history of inflammatory bowel disease (includes Crohn's disease and ulcerative colitis). Participants with irritable bowel syndrome can be included in the clinical investigation.\n* Participant has undergone major anorectal or bowel surgery or has ongoing anorectal or bowel conditions where primary surgery is considered the best, e.g., congenital anorectal malformation, bowel resection surgery, unrepaired rectovaginal fistula, chronic 4th degree anal sphincter laceration, full thickness rectal\u002Fanal prolapse. If it can be excluded that the participant's symptoms are related to any of the above surgeries\u002Fconditions, they can be included in the clinical investigation.",{"count":18,"type":19},[53],"UCon is a medical device for treating the symptoms of overactive bladder (OAB) and bowel dysfunction (BD). It electrically stimulates the DGN through the skin to obtain modulated behavior of the bladder\u002Fbowel musculature e.g., suppressing undesired bladder\u002Fbowel activity to relieve the symptoms of the patient.\n\nThis pivotal clinical investigation is designed as a stratified-randomized, single-blinded, controlled, confirmatory, prospective, multicenter clinical investigation.",[23,27,114,115,203,117,112,113],"Urinary",[23,112,119,120,121],"2025-03-26",{"date":207,"type":32},"2025-03-27",{"date":209,"type":32},"2025-03-20",{"date":211,"type":19},"2028-03-20",{"name":130,"class":39},{"id":214,"slug":215,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":79,"minAge":80,"maxAge":220,"enrollmentInfo":221,"targetDuration":4,"studyType":51,"phases":223,"briefSummary":224,"conditions":225,"keywords":227,"overallStatus":161,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":4},"100563554","transcutaneous-tibial-nerve-stimulation-for-overactive-bladder-syndrome-and-associated-gait-changes-in-post-menopausal-women-100563554","NCT06617676","Transcutaneous Tibial Nerve Stimulation for Overactive Bladder Syndrome and Associated Gait Changes in Post-menopausal Women","TTNS","Inclusion Criteria: Inclusion criteria include females over 60 years of age who score an 8 or greater on the OAB-V8 with no exclusion criteria.\n\n\\-\n\nExclusion Criteria: those who experience stress UI only, have a pacemaker, neurologic deficit (e.g. Parkinson\\'s disease, multiple sclerosis, spinal cord injury), current urinary tract infection, known active cancer, or current OAB medication use (Tolterdine, etc.) with consideration of a washout period, and inability to walk 30 meters.\n\n\\-","85 Years",{"count":222,"type":19},60,[53],"The goal of this clinical trial is to learn if surface tibial electrical stimulation (mild electrical signals on the inside of the ankle) helps women 60 years or older with urine leakage that happens on the way to the bathroom or at night time. The main questions it aims to answer are: 1). How many treatments per week over a 12-week period improve a person\\'s bladder symptoms?; 2). Is a person more confident that they will not fall and \u002F or leak urine on the way to the bathroom after the treatment with the electrical stimulation treatments; 3). Does the way a person walks when they need to go to the bathroom change after they have had the electrical stimulation? They will visit the clinic 3 times to complete several questionnaires and walk with a full bladder and empty bladder. On the first visit, the participant will be taught how to use the electrical stimulation device. Participants will either receive the treatment 2 or 4 times per week for 12 weeks or no treatment with the option to receive treatment following the 12 weeks. Participants will be given a bladder diary to complete at the start of treatment, at 6 weeks, then at 12 weeks and will be instructed in completion. They will drink water until they have a strong urge to urinate, then will walk along an electronic pathway and will go empty their bladder. After emptying, they will walk back along the electronic pathway again. They will also complete a Timed Up and Go test - stand up from a chair, walk 3 meters, then turn around, walk back, then sit down. At the 6th week follow up and the 12th week follow up, they will complete each questionnaire again and complete the walking tasks again.",[226,27,114],"Overactive Bladder Syndrome",[228,229,230,231,232,114],"Overactive bladder syndrome","Transcutaneous sacral nerve stimulation","Falls","Urinary urgency","Urinary frequency","2024-09-26",{"date":235,"type":32},"2024-09-27",{"date":237,"type":19},"2024-10",{"date":239,"type":19},"2026-03",{"name":241,"class":68},"Louisiana State University Health Sciences Center Shreveport"]