[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nocturia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nocturia":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,13,0,[8,48,72,100,126,160,188,210,234,259,281,301,330],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100602506","electroacupuncture-as-a-treatment-for-refractory-overactive-bladder-100602506",false,"NCT07124390","Electroacupuncture as a Treatment for Refractory Overactive Bladder","Electroacupuncture as a Treatment for Refractory Overactive Bladder: A Feasibility \u002FPilot Randomized Controlled Trial","EAOAB","Inclusion Criteria:\n\nParticipants must meet all of the following criteria:\n\n* Female adults aged 18 years or older.\n* Diagnosed with overactive bladder syndrome (ICIQ-OAB score ≥10).\n* Symptoms present for at least three months and refractory to first-line treatments.\n* Willing to refrain from starting new bladder-related treatments during the study period.\n* Able and willing to provide written informed consent.\n\nExclusion Criteria:\n\n* Participants meeting any of the following criteria will be excluded:\n\n  * Pregnant or planning pregnancy during the study period.\n  * Bleeding disorders.\n  * Severe needle phobia.\n  * Presence of a pacemaker.\n  * Active cancer diagnosis.\n  * Active urinary tract infections or other urological conditions requiring urgent intervention.\n  * Participation in another clinical trial for bladder dysfunction within the past six months.\n  * Neurological conditions affecting continence (e.g., diabetic neuropathy, multiple sclerosis, Parkinson's disease).\n  * Life-threatening infections.\n  * Severe cognitive deficits, unconsciousness, dementia (e.g., Alzheimer's or other neurodegenerative diseases).\n  * History of incontinence surgery.\n  * Previous acupuncture for OAB within the past two months.\n  * History of thromboses.\n  * Recovering from or suffering from a serious illness or major surgery.","FEMALE","18 Years",{"count":20,"type":21},32,"ESTIMATED","INTERVENTIONAL",[24],"NA","This study is a single-site feasibility randomised controlled trial evaluating the feasibility and acceptability of electroacupuncture (EA), percutaneous tibial nerve stimulation (PTNS), and sham electroacupuncture in women with refractory overactive bladder (OAB) who have not achieved satisfactory improvement following standard pelvic health physiotherapy.\n\nThe primary aim is to determine whether a larger definitive trial is feasible by assessing recruitment, consent, retention, treatment adherence, data completeness, intervention delivery, blinding credibility, safety, and participant acceptability.\n\nThirty-six participants will be randomly allocated to receive electroacupuncture, PTNS, or sham electroacupuncture over a 12-week treatment period. Outcome assessments will be completed at baseline, 6 weeks, 12 weeks, 6 months, and 12 months.\n\nThe findings will inform the design of a future definitive randomised controlled trial and contribute to the evidence base for non-pharmacological treatment options for overactive bladder.",[27,28,29],"Over Active Bladder","Urinary Incontinence (UI)","Nocturia",[31,32,33,34],"Electric-Acupuncture","Acupuncture","PTNS","Neuromodulation","NOT_YET_RECRUITING","2026-06-13",{"date":38,"type":39},"2026-06-16","ACTUAL",{"date":41,"type":21},"2026-07-01",{"date":43,"type":21},"2027-07-30",{"name":45,"class":46},"Chelsea and Westminster NHS Foundation Trust","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":54,"sex":17,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":22,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":71},"100446229","a-pilot-study-to-evaluate-purewick-for-nocturia-100446229","NCT05090722","A Pilot Study to Evaluate PureWick for Nocturia","Inclusion Criteria:\n\n* Women aged 50 years or older.\n* Experiences 2 or more voids per night as assessed on a 3-day bladder diary.\n\nExclusion Criteria:\n\n* Compromised skin integrity in the perineal area (e.g., ulcers, open wounds, etc.).\n* Neurological impairment or psychiatric disorder preventing proper understanding of consent.\n* Unable to operate the PureWick system.\n* Unable to complete required questionnaires and diaries.\n* Investigator deems subject as unsuitable for enrollment.",true,"50 Years",{"count":57,"type":21},40,[24],"This is a single-center prospective pilot study of PureWick used as a management for nocturia and reduction of nighttime falls associated with going to the bathroom. Subjects are followed up to 3 months after the intervention. As a pilot study, it is expected that a 3-month follow-up will adequately capture urinary and sleep outcomes data and any adverse events related or unrelated to the study device.",[29],"RECRUITING","2026-06-11",{"date":64,"type":39},"2026-06-15",{"date":66,"type":39},"2021-12-16",{"date":68,"type":21},"2027-10",{"name":70,"class":46},"Northwell Health",2,{"id":73,"slug":74,"hasResults":11,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":17,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":4,"studyType":22,"phases":83,"briefSummary":84,"conditions":85,"keywords":87,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":47},"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":82,"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.",[86,29],"Overactive Bladder (OAB)",[88,89,90],"transcutaneous tibial nerve stimulation","overactive bladder","nocturia","2026-06-03",{"date":93,"type":39},"2026-06-09",{"date":95,"type":21},"2026-06-10",{"date":97,"type":21},"2027-06-10",{"name":99,"class":46},"Qilu Hospital of Shandong University",{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":105,"acronym":4,"eligibilityCriteria":106,"healthyVolunteers":54,"sex":107,"minAge":108,"maxAge":4,"enrollmentInfo":109,"targetDuration":4,"studyType":22,"phases":111,"briefSummary":112,"conditions":113,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":47},"100638172","moxibustion-for-nocturia-100638172","NCT07598227","Moxibustion for Nocturia","Evaluation of the Efficacy and Safety of Acupoint Moxibustion for Nocturia: A Pilot Study","Inclusion Criteria:\n\n* Patients aged 40 years or older.\n* Experiencing two or more nocturia episodes per night.\n\nExclusion Criteria\n\n* Active urinary tract infection (UTI).\n* Poorly controlled diabetes mellitus (defined as HbA1c \\> 6.5%).\n* Presence of a neurogenic bladder caused by conditions such as multiple sclerosis, Parkinson's disease, stroke, spinal cord injury, or nerve damage resulting from major pelvic surgery.\n* Severe congestive heart failure (New York Heart Association \\[NYHA\\] functional class \\> II).\n* Use of other Traditional Chinese Medicine (TCM) therapies for nocturia symptoms within the past month (30 days).\n* Pregnant women.","ALL","40 Years",{"count":110,"type":21},100,[24],"Nocturia, the interruption of sleep due to nighttime voiding, severely compromises quality of life, emotional health, and overall well-being when occurring twice or more per night. Given that some patients experience inadequate responses to conventional Western therapies or harbor concerns about the long-term side effects of pharmaceuticals, many are turning to Traditional Chinese Medicine (TCM) for alternative solutions. This study utilized a randomized clinical trial design to investigate the efficacy and safety of acupoint moxibustion for nocturia.",[29,114,115,116],"Acupoint","Moxibustion","Traditional Chinese Medicine","2026-05-17",{"date":119,"type":39},"2026-05-20",{"date":121,"type":39},"2025-01-01",{"date":123,"type":21},"2026-12-31",{"name":125,"class":46},"Buddhist Tzu Chi General Hospital",{"id":127,"slug":128,"hasResults":11,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":4,"eligibilityCriteria":132,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":133,"targetDuration":4,"studyType":22,"phases":135,"briefSummary":136,"conditions":137,"keywords":145,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":159},"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":134,"type":21},20,[24],"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.",[138,139,140,141,29,142,143,144],"Urinary Incontinence","Urinary Incontinence, Urge","Fecal Incontinence","Fecal Incontinence With Fecal Urgency","Urinary Frequency More Than Once at Night","Bowel Disorders Functional","Incontinence, Nighttime Urinary",[138,140,146,147,148],"Urge incontinence","Neurostimulation","Dorsal Genital Nerve","2026-02-16",{"date":151,"type":39},"2026-02-18",{"date":153,"type":39},"2024-01-12",{"date":155,"type":21},"2027-01-01",{"name":157,"class":158},"InnoCon Medical","INDUSTRY",3,{"id":161,"slug":162,"hasResults":11,"nctId":163,"briefTitle":164,"officialTitle":165,"acronym":166,"eligibilityCriteria":167,"healthyVolunteers":11,"sex":17,"minAge":168,"maxAge":4,"enrollmentInfo":169,"targetDuration":4,"studyType":22,"phases":171,"briefSummary":172,"conditions":173,"keywords":177,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":178,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":187},"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","22 Years",{"count":170,"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).",[86,174,175,29,176],"Urinary Urgency","Urinary Urge Incontinence (UUI)","Urinary Frequency",[86],"2025-10-24",{"date":180,"type":39},"2025-10-27",{"date":182,"type":39},"2025-03-17",{"date":184,"type":21},"2028-07",{"name":186,"class":46},"Medstar Health Research Institute",10,{"id":189,"slug":190,"hasResults":11,"nctId":191,"briefTitle":192,"officialTitle":193,"acronym":4,"eligibilityCriteria":194,"healthyVolunteers":11,"sex":195,"minAge":18,"maxAge":4,"enrollmentInfo":196,"targetDuration":4,"studyType":22,"phases":197,"briefSummary":198,"conditions":199,"keywords":201,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":202,"lastUpdatePostDateStruct":203,"startDateStruct":205,"completionDateStruct":207,"leadSponsor":209,"locationsCount":47},"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":134,"type":21},[24],"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.",[138,200,29,142,139,144],"Urge Incontinence",[138,146,147,148,29],"2025-09-30",{"date":204,"type":39},"2025-10-01",{"date":206,"type":39},"2023-10-12",{"date":208,"type":21},"2026-06-12",{"name":157,"class":158},{"id":211,"slug":212,"hasResults":11,"nctId":213,"briefTitle":214,"officialTitle":215,"acronym":216,"eligibilityCriteria":217,"healthyVolunteers":11,"sex":107,"minAge":218,"maxAge":4,"enrollmentInfo":219,"targetDuration":4,"studyType":22,"phases":221,"briefSummary":222,"conditions":223,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":225,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":71},"100524542","multi-center-trial-to-improve-nocturia-and-sleep-in-older-adults-100524542","NCT06110091","Multi-center Trial to Improve Nocturia and Sleep in Older Adults","Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT)","MINT","Inclusion Criteria:\n\n* Age ≥ 60 years\n* Average of ≥ 2 episodes per night of nocturia on the International Consultation on Incontinence Questionnaire-Overactive Bladder Module (ICIQ-OAB) questionnaire\n* Insomnia Severity Index \\> 7\n* Able to attend weekly study visits\n\nExclusion Criteria:\n\n* Prior cognitive behavioral therapy for insomnia\n* Presence of bipolar disorder\n* Significant cognitive impairment as measured by a score \\\u003C 20 on the Mini-Mental State Exam\n* Sleep disturbance better explained by another sleep disorder such as restless legs syndrome, narcolepsy, insufficient sleep syndrome, or circadian rhythm sleep-wake disorders\n* Untreated sleep-disordered breathing (respiratory event index ≥ 15 plus • Epworth Sleepiness Scale \\> 10 or respiratory event index \\> 30. Note that participants with treated sleep-disordered breathing will not be excluded)\n* Current urinary tract infection or hematuria\n* Unstable doses or recent changes in bladder medication\n* New or recently discontinued insomnia medication within past month\n* Previous or current intensive behavioral therapy for insomnia or urinary symptoms,\n* Unstable health conditions expected to result in death or hospitalization within 3 months, as assessed by overall study PIs or Site PI.\n* Unstable medical conditions that could contribute to nocturia or insomnia such as poorly controlled heart failure as evidenced on physical examination, poorly controlled diabetes mellitus with either hemoglobin A1c of ≥ 9.0, or chronic kidney disease (stage 4 or 5) or a potential to initiate dialysis in 3 months\n* Unstable psychiatric conditions (e.g., psychosis, active alcohol\u002Fsubstance abuse based on history and medical records)\n* Unstable housing situation\n* Evidence of significant urinary retention as measured by a residual bladder volume of ≥ 200 mL by bladder ultrasound with 15 minutes of voiding\n* Genitourinary cancer undergoing active treatment\n* Pelvic or colon surgery within 6 months of enrollment or onabotulinum toxin therapy for urinary symptoms within 6 months of enrollment","60 Years",{"count":220,"type":21},192,[24],"The Multi-center Trial to Improve Nocturia and Sleep in Older Adults (MINT) study is a randomized trial to determine and assess the efficacy of integrated treatment of coexisting nocturia and insomnia, as well as explore the effects of this treatment on quality of life.",[29,224],"Insomnia","2025-09-29",{"date":202,"type":39},{"date":228,"type":39},"2023-12-05",{"date":230,"type":21},"2028-08",{"name":232,"class":233},"Atlanta VA Medical Center","FED",{"id":235,"slug":236,"hasResults":11,"nctId":237,"briefTitle":238,"officialTitle":239,"acronym":240,"eligibilityCriteria":241,"healthyVolunteers":11,"sex":107,"minAge":18,"maxAge":4,"enrollmentInfo":242,"targetDuration":4,"studyType":244,"phases":4,"briefSummary":245,"conditions":246,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":250,"lastUpdatePostDateStruct":251,"startDateStruct":253,"completionDateStruct":255,"leadSponsor":257,"locationsCount":47},"100462334","lymphoedema-and-nocturianocturnal-polyuria-after-pelvic-lnd-for-urogenital-cancer-100462334","NCT05300308","Lymphoedema and Nocturia\u002FNocturnal Polyuria After Pelvic LND for Urogenital Cancer","Lymphoedema and Nocturia\u002F Nocturnal Polyuria After Pelvic Lymph Node Dissection (LND): Prospective Observational Study","UroLymph","Inclusion Criteria:\n\n* Non-metastatic urogenital cancer (i.e. prostate cancer or bladder cancer)\n* Planned transperitoneal pelvic lymph node dissection or salvage lymph node dissection\n* Salvage lymph node dissection\n* Before inclusion, written informed consent must be given according to ICH\u002FGCP, and national\u002Flocal regulations.\n\nExclusion Criteria:\n\n* Radiological evidence of metastatic disease based on pelvic CT\u002FMRI and bone scan\n* Clinical signs of chronic venous insufficiency (CEAP C3-C6)\n* History of lymph node dissection\u002F radiotherapy at the level of the pelvis or groin",{"count":243,"type":21},150,"OBSERVATIONAL","After the treatment of urogenital cancer, a person may develop lymphoedema of the leg(s) and\u002F or midline region. Clinical symptoms include abnormal tissue swelling, sensation of limb heaviness, erythema, pain, and impaired limb function. Lymphoedema can have a negative impact on quality of life (QoL) and the impact of lymphoedema on the cancer treatment decision making process is underestimated. A limited number of studies have evaluated the incidence rate of midline and leg lymphoedema after surgery for urogenital cancers and have investigated the prognostic variables. In addition, to the researchers knowledge, no evidence exists regarding which (combination of) clinical measuring methods are most sensitive to detect early lymphoedema at the lower limbs after the treatment of urogenital cancer. Therefore, in this prospective observational study, the epidemiology (i.e. incidence\u002F prevalence rate and prognostic variables) and the detection methods of lower limb lymphoedema after pelvic lymph node dissection for urogenital cancer will be investigated.\n\nAdditionally, the epidemiology of nocturia and nocturnal polyuria will be studied (since this information is also missing in literature).",[247,248,29,249],"Urogenital Cancer","Lower Limb Lymphedema","Nocturnal Polyuria","2025-07-08",{"date":252,"type":39},"2025-07-11",{"date":254,"type":39},"2022-01-21",{"date":256,"type":21},"2026-11",{"name":258,"class":46},"Universitaire Ziekenhuizen KU Leuven",{"id":260,"slug":261,"hasResults":11,"nctId":262,"briefTitle":263,"officialTitle":264,"acronym":4,"eligibilityCriteria":265,"healthyVolunteers":11,"sex":107,"minAge":18,"maxAge":4,"enrollmentInfo":266,"targetDuration":4,"studyType":22,"phases":268,"briefSummary":269,"conditions":270,"keywords":272,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":273,"lastUpdatePostDateStruct":274,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":159},"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":267,"type":21},180,[24],"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.",[138,139,29,142,271,144,140,141],"Urinary",[138,140,146,147,148],"2025-03-26",{"date":275,"type":39},"2025-03-27",{"date":277,"type":39},"2025-03-20",{"date":279,"type":21},"2028-03-20",{"name":157,"class":158},{"id":282,"slug":283,"hasResults":11,"nctId":284,"briefTitle":285,"officialTitle":286,"acronym":4,"eligibilityCriteria":287,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":288,"targetDuration":4,"studyType":244,"phases":4,"briefSummary":290,"conditions":291,"keywords":4,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":297,"leadSponsor":299,"locationsCount":47},"100582709","examination-of-the-effect-of-nocturia-on-pelvic-floor-symptoms-sleep-parameters-and-quality-of-life-in-women-with-urinary-incontinence-100582709","NCT06866834","Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Sleep Parameters and Quality of Life in Women with Urinary Incontinence","Examination of the Effect of Nocturia on Pelvic Floor Symptoms, Chronotype, Sleepiness, Sleep Quality, Fatigue and Quality of Life in Women with Urinary Incontinence","Inclusion Criteria:\n\nInclusion Criteria for the Group with Nocturia:\n\n* Being 18 years of age or older\n* Being female\n* Have been diagnosed with urinary incontinence\n* Wake up during the main sleep period to relieve the need to urinate, with the intention of returning to sleep or falling asleep again after each urination\n\nInclusion Criteria for the Group without Nocturia:\n\n* Being 18 years of age or older\n* Being female\n* Have been diagnosed with urinary incontinence\n\nExclusion Criteria:\n\nExclusion Criteria for the Group with Nocturia:\n\n* Diagnosis of a sleep disorder\n* Diagnosis of any neurological disease\n* Chronic kidney disease\n* Diagnosis of diabetes\n* Use of sleep medications\n* Use of antidepressants\n* Use of diuretic medications\n* Use of any medication for urinary incontinence\n* Hormone replacement therapy\n* Pregnancy or having given birth within the last six months\n* Having had a urinary tract infection in the last three months\n* Presence of prolapse greater than stage 2\n* History of orthopedic trauma to the pelvic region\n* Pelvic surgery within the last six months\n* History of cancer\n\nExclusion Criteria for the Group without Nocturia:\n\n* Waking up during the main sleep period to relieve the need to urinate, with the intention of returning to sleep or falling asleep again after each urination\n* Diagnosis of a sleep disorder\n* Diagnosis of any neurological disease\n* Chronic kidney disease\n* Diagnosis of diabetes\n* Use of sleep medications\n* Use of antidepressants\n* Use of diuretic medications\n* Use of any medication for urinary incontinence\n* Hormone replacement therapy\n* Pregnancy or having given birth within the last six months\n* Having had a urinary tract infection in the last three months\n* Presence of prolapse greater than stage 2\n* History of orthopedic trauma to the pelvic region\n* Pelvic surgery within the last six months\n* History of cancer",{"count":289,"type":21},102,"Urinary incontinence (UI), a common issue, is the involuntary leakage of urine that negatively affects individuals socially, physically, and psychologically, leading to a decreased quality of life. Nocturia, which is often seen alongside UI, has similar adverse effects. Nocturia refers to the number of urinations during the main sleep period, and it should be accompanied by the intention to fall back asleep after waking up. Nocturia can arise from factors such as sleep disorders and circadian rhythm disturbances. The circadian rhythm regulates the body's biological functions, and this rhythm varies from person to person, creating chronotypes. There is a strong relationship between sleep and nocturia because nocturia leads to deep sleep loss, an increased risk of metabolic diseases, decreased sleep quality and sleep efficiency, and an increase in the number of awakenings after sleep onset. It is necessary to distinguish whether nocturia, which has a comprehensive impact, affects pelvic floor symptoms, chronotype, sleep quality, fatigue, sleepiness, and quality of life in women with UI. Therefore, the aim of this study is to examine the effect of nocturia on pelvic floor symptoms, chronotype, sleepiness, sleep quality, fatigue, and quality of life in women with UI.",[292,28,29],"Women","2025-03-04",{"date":295,"type":39},"2025-03-10",{"date":121,"type":39},{"date":298,"type":21},"2025-06-01",{"name":300,"class":46},"Gulhane School of Medicine",{"id":302,"slug":303,"hasResults":11,"nctId":304,"briefTitle":305,"officialTitle":305,"acronym":306,"eligibilityCriteria":307,"healthyVolunteers":11,"sex":17,"minAge":218,"maxAge":308,"enrollmentInfo":309,"targetDuration":4,"studyType":22,"phases":311,"briefSummary":312,"conditions":313,"keywords":315,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"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":310,"type":21},60,[24],"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.",[314,139,29],"Overactive Bladder Syndrome",[316,317,318,319,320,29],"Overactive bladder syndrome","Transcutaneous sacral nerve stimulation","Falls","Urinary urgency","Urinary frequency","2024-09-26",{"date":323,"type":39},"2024-09-27",{"date":325,"type":21},"2024-10",{"date":327,"type":21},"2026-03",{"name":329,"class":46},"Louisiana State University Health Sciences Center Shreveport",{"id":331,"slug":332,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":337,"targetDuration":4,"studyType":22,"phases":338,"briefSummary":340,"conditions":341,"keywords":346,"overallStatus":61,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":71},"100385978","phase-4-post-procedural-pain-associated-with-5-versus-20-intravesical-injections-of-onabotulinumtoxin-a-100385978","NCT04305743","Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A","Post-procedural Pain Associated With 5 Versus 20 Intravesical Injections of Onabotulinumtoxin A for Treatment of Overactive Bladder: a Multi-center Randomized Controlled Trial","Inclusion Criteria:\n\n* Women \\>=18 years of age with diagnosis of urinary urgency, urinary frequency, urgency urinary incontinence, overactive bladder.\n* Procedure scheduled in either the outpatient clinic or the operating room to be performed without use of sedation, general, or neuraxial anesthesia.\n\nExclusion Criteria:\n\n* Male gender.\n* Women \\\u003C18 years of age.\n* Non-English speaking.\n* Pregnancy (patient will self-report pregnancy).\n* Participant has symptoms of overactive bladder due to any known neurological reason (e.g. spinal cord injury, multiple sclerosis, cerebrovascular accident, Alzheimer's disease, Parkinson's disease, etc.)\n* Participant uses clean intermittent catheterization or indwelling catheter to manage urinary incontinence.\n* Participant has a history or current diagnosis of bladder cancer or other urothelial malignancy.\n* Participant has a known allergy or sensitivity to any botulinum toxin preparation.\n* Participant has any medical condition that may put her at increased risk with exposure to onabotulinumtoxin A, including diagnosed myasthenia gravis, Eaton-Lambert syndrome, or amyotrophic lateral sclerosis.\n* Participant is scheduled for administration of onabotulinumtoxin A with use of sedation, general, or neuraxial anesthesia.",{"count":310,"type":21},[339],"PHASE4","Currently, in clinical practice there has been no standardization in the number of injections a single dose of intradetrusor onabotulinumtoxin A is administered in. Given the increasing use of this treatment modality, the aim of this study is to compare outcomes for patients given a 100 unit dose of onabotulinumtoxin A split into 5 as compared to 20 injections for the treatment of overactive bladder or urgency urinary incontinence refractory to medical treatment.",[342,343,344,345,142,29],"Urinary Bladder, Overactive","Incontinence, Urge","Incontinence, Urinary","Urinary Urge Incontinence",[89,347,348,349,350],"urgency urinary incontinence","onabotulinumtoxin","bladder","botox","2020-11-03",{"date":353,"type":39},"2020-11-05",{"date":355,"type":39},"2019-10-09",{"date":357,"type":21},"2021-06-01",{"name":359,"class":46},"University of South Florida"]