[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"stress-urinary-incontinence-sui\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:stress-urinary-incontinence-sui":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,22,0,[8,46,87,116,140,168,190,212,237,272,296,318,341,363,388,412,434,460,483,515,535,565],{"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":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100583227","phase-3-pivotal-study-of-voro-urologic-scaffold-100583227",false,"NCT06873581","Pivotal Study of Voro Urologic Scaffold","A Pivotal Study of Voro Urologic Scaffold for the Treatment of Post Prostatectomy Stress Urinary Incontinence (ARID II)","ARID II","Inclusion Criteria:\n\n1. Male \\>= 45 years of age of any race and ethnic group\n2. Diagnosed with prostate cancer and scheduled for radical prostatectomy\n3. Gleason Grade Group 4 or lower\n4. Prostate size less than 80 grams, as measured by Magnetic Resonance Imaging (MRI)\n5. Able and willing to provide written consent to participate in the study\n6. Able and willing to comply with study follow-up visits and procedures\n7. Willing to forego any other procedures for stress urinary incontinence (SUI) during the study\n\nExclusion Criteria:\n\n1. Malignant tumors with known bladder neck or urethral sphincter invasion or metastatic disease confirmed via baseline assessments (example \\[e.g.,\\] Multiparametric magnetic resonance imaging \\[mpMRI\\], bone scan)\n2. History of urinary incontinence, including stress or urge urinary incontinence\n3. Demonstration of SUI, such as positive 1 hour pad weight test or participant reported incontinence episodes\n4. Currently treated with medications to treat overactive bladder (OAB)\n5. Post void residual \\>200 milliliter (ml) or \\> 25 percentage (%) total volume(= voided volume + residual volume)\n6. Presence of urethral stricture or bladder neck contracture\n7. History of urethral stricture\n8. Current or chronic urinary tract infection\n9. Prior urologic outlet surgical or minimally invasive procedure (e.g., Transurethral resection of the prostate \\[TURP\\], Holmium laser enucleation of the prostate \\[HoLEP,\\] Rezum, etc.).\n10. Prior pelvic radiation or anticipated need for radiation after radical prostatectomy\n11. History of neurogenic lower urinary tract dysfunction\n12. History or current need for intermittent urinary catheterization\n13. Body mass index \\>40\n14. History of cancer (excluding prostate cancer meeting the inclusion criteria) which is not considered in complete 5 year remission (excluding squamous and basal cell skin carcinoma)\n15. History of bladder malignancy\n16. Diagnosed or suspected primary neurologic conditions known to affect voiding function\n17. History of clinically significant congestive heart failure (i.e., New York Heart Association \\[NYHA\\] Class III and IV)\n18. Current uncontrolled diabetes (i.e., hemoglobin A1c \\[glycated hemoglobin or glycosylated hemoglobin\\] \\>=7.5%)\n19. Current overactive bladder defined as a score of \\> 8 on the Overactive Bladder Questionnaire (OAB-8) administered at the baseline visit\n20. History of immunosuppressive conditions or on medications which modulate the immune system\n21. Any significant medical history that would pose an unreasonable risk or make the participant unsuitable for the study per investigator discretion\n22. Participant with planned concomitant surgery\n23. Anterior fascial sparing radical prostatectomy\n24. Retzius sparing radical prostatectomy\n25. Participant currently participating in other investigational studies unless approved by the Sponsor in writing\n26. Participant is, in the investigator's judgement, part of a vulnerable population, including but not limited to:\n\n    1. Prisoners\n    2. Individuals pending incarceration\n    3. Individuals experiencing any cognitive or psychiatric condition that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires\n27. Planned adjuvant radiation therapy","MALE","45 Years",{"count":20,"type":21},266,"ESTIMATED","INTERVENTIONAL",[24],"PHASE3","The objective of this study is to compare safety and effectiveness of the Voro Urologic Scaffold in adult men undergoing robotic assisted radical prostatectomy as compared to control arm.\n\nThe study is a multi-center, single blind, randomized, controlled trial. Up to 266 participants will be treated at up to 30 centers in the United States. The study will consist of a Baseline visit, implantation during robotic assisted radical prostatectomy (RARP), catheter removal, 6 weeks, 6 months, 12 months, 18 months, and 24 months.",[27,28],"Radical Prostatectomy","Stress Urinary Incontinence (SUI)",[30,27,31,15,32],"SUI","Voro Urologic Scaffold","Post-prostatectomy incontinence","RECRUITING","2026-06-21",{"date":36,"type":37},"2026-06-23","ACTUAL",{"date":39,"type":37},"2025-04-18",{"date":41,"type":21},"2028-04-30",{"name":43,"class":44},"Levee Medical, Inc.","INDUSTRY",19,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":50,"acronym":4,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":58,"conditions":59,"keywords":62,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":86},"100641229","phase-4-suzetrigine-for-opioid-sparing-postoperative-analgesia-following-transvaginal-pelvic-reconstructive-surgery-100641229","NCT07600697","Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery","Inclusion Criteria:\n\n* Age ≥ 18 years.\n* Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.\n* Able to provide written informed consent.\n\nExclusion Criteria:\n\n* Chronic opioid use.\n* Liver failure.\n* End-stage renal disease (ESRD).\n* Chronic pain syndromes, including:\n\nFibromyalgia Interstitial cystitis Chronic pelvic pain\n\n* Contraindication to acetaminophen or ibuprofen.\n* Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.","FEMALE","18 Years",{"count":55,"type":21},120,[57],"PHASE4","Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.",[60,28,61],"Pelvic Organ Prolapse (POP)","Postoperative Pain",[63,64,65,66,67,68,69,70,71,72,73,74],"Suzetrigine","NaV1.8 Inhibitor","Non-opioid analgesic","pelvic reconstructive surgery","transvaginal surgery","postoperative pain","opioid-sparing analgesia","multimodal pain management","pelvic organ prolapse","randomized clinical trial","stepped-wedge design","phase 4 trial","NOT_YET_RECRUITING","2026-05-29",{"date":78,"type":37},"2026-06-02",{"date":80,"type":21},"2026-07-01",{"date":82,"type":21},"2028-07-01",{"name":84,"class":85},"University of California, Los Angeles","OTHER",1,{"id":88,"slug":89,"hasResults":11,"nctId":90,"briefTitle":91,"officialTitle":92,"acronym":4,"eligibilityCriteria":93,"healthyVolunteers":94,"sex":52,"minAge":53,"maxAge":95,"enrollmentInfo":96,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":99,"conditions":100,"keywords":101,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100638913","differences-in-pelvic-floor-motion-level-among-chinese-women-and-construction-of-an-assessment-system-100638913","NCT07608146","Differences in Pelvic Floor Motion Level Among Chinese Women and Construction of an Assessment System","Differences in Pelvic Floor Movement Levels Based on Population Characteristics and the Construction of an Assessment System","Inclusion Criteria:\n\n* Female, aged between 18 and 60 years old\n* Signed the informed consent form\n* Healthy group demonstrated no pelvic floor dysfunction\n* SUI group had stress urinary incontinence symptom\n\nExclusion Criteria:\n\n* Participants with cognitive behavioral disorders, mental illnesses, or those who are unable to cooperate\n* Participants who cannot demonstrate correct pelvic floor muscle contraction\n* Participants who were within 1 year postpartum\n* Participants who were post hysterectomy\n* Participants who had pain during internal exam or refused to have internal exam\n* SUI group who had pelvic organ prolapse symptoms or whose POP-Q lowest level reached or exceeded the hymenal ring\n* SUI group had urgency urinary incontinence symptoms\n* SUI group had chronic constipation symptoms",true,"60 Years",{"count":97,"type":21},2000,"OBSERVATIONAL","The purpose of this study is to integrate millimeter-wave radar technology to investigate the dynamic movement characteristics of the pelvic floor muscles in patients with different Body Mass Index (BMI) and stress urinary incontinence. Based on this, a large database of pelvic floor movement parameters for Chinese women will be constructed, and a multi-subgroup standard atlas of pelvic floor muscle movement will be established to promote the standardized application of this technology in obstetrics and gynecology clinical assessments. This study also aims to explore the clinical value of pelvic floor movement assessment within the pelvic floor evaluation system, providing directions and insights for establishing a systematic evaluation system and standardizing the diagnosis and treatment of pelvic floor disorders.",[28],[102,103,104,105],"Stress urinary incontinence","Pelvic floor muscle strength","Non-invasive technology","Pelvic floor dysfunction","2026-05-24",{"date":108,"type":37},"2026-05-27",{"date":110,"type":21},"2026-05-30",{"date":112,"type":21},"2027-08-31",{"name":114,"class":85},"Peking Union Medical College Hospital",20,{"id":117,"slug":118,"hasResults":11,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":11,"sex":52,"minAge":123,"maxAge":124,"enrollmentInfo":125,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":127,"conditions":128,"keywords":129,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":131,"lastUpdatePostDateStruct":132,"startDateStruct":134,"completionDateStruct":136,"leadSponsor":138,"locationsCount":86},"100640259","development-and-validation-of-a-risk-prediction-model-for-de-novo-stress-urinary-incontinence-after-pelvic-floor-reconstruction-surgery-100640259","NCT07601282","Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery","Development and Validation of a Risk Prediction Model for De Novo Stress Urinary Incontinence After Pelvic Floor Reconstruction Surgery: A Case-Control Study","Inclusion Criteria:\n\n1. Patients with pelvic organ prolapse quantification (POP-Q) stage II or higher;\n2. Patients who require surgical treatment for pelvic organ prolapse;\n3. Patients with no evidence of urinary incontinence before surgery.\n\nExclusion Criteria:\n\n1. Patients confirmed to have urinary incontinence before surgery;\n2. Patients with urinary or reproductive system infections;\n3. Patients with a history of prior surgery for urinary incontinence;\n4. Patients who have undergone previous mesh repair surgery for pelvic organ prolapse;\n5. Patients with a history of psychiatric disorders, hearing impairment, or communication difficulties;\n6. Patients receiving hormone replacement therapy;\n7. Patients with neurodegenerative diseases such as stroke or multiple sclerosis, or neurological conditions such as spinal cord injury.","20 Years","90 Years",{"count":126,"type":21},382,"This observational study aims to develop a predictive model for the occurrence of new-onset stress urinary incontinence (SUI) after pelvic organ prolapse (POP) repair surgery in women. The primary questions it seeks to answer are:\n\nWhich risk factors and anatomical characteristics predispose women to new-onset stress urinary incontinence following pelvic organ prolapse repair surgery?\n\nFemale POP patients without any preoperative symptoms of urinary incontinence will receive telephone follow-ups at 3, 6, and 12 months after undergoing standard surgical treatment.",[60,28],[130],"Case-Control Study","2026-05-16",{"date":133,"type":37},"2026-05-22",{"date":135,"type":37},"2024-12-01",{"date":137,"type":21},"2026-12-31",{"name":139,"class":85},"Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine",{"id":141,"slug":142,"hasResults":11,"nctId":143,"briefTitle":144,"officialTitle":145,"acronym":146,"eligibilityCriteria":147,"healthyVolunteers":11,"sex":52,"minAge":148,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":151,"briefSummary":153,"conditions":154,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":167},"100584176","augmenting-urinary-reflex-activity-study-4-including-extended-indications-100584176","NCT06885931","Augmenting Urinary Reflex Activity Study 4 (Including eXtended Indications)","Exploratory Safety and Feasibility Study of Personalized Adaptive Pudendal Neuromodulation for Mixed Urinary Incontinence and Extended Indications Using an Implanted (Picostim IITM) System","AURA-4X","Inclusion Criteria:\n\n* Female. NB: the definition of female refers to sex at birth.\n* Adult: aged ≥ 22 years (at the time of informed consent signature).\n* Patient self-reports both stress and urge episodes (clinician-opinion on history taking).\n* Patient has failed to respond to or could not tolerate conservative treatment as determined by the treating health care provider.\n* Duration of urinary incontinence symptom ≥ 6 months prior to the screening baseline visit date.\n* Able and willing to voluntarily sign informed consent form.\n* Able to participate in all testing and follow-up clinic visits associated with study protocol.\n* Patient is mobile and able to use a toilet.\n* In the opinion of the Investigator, the patient is capable of independently using the system components (after training).\n\nExclusion Criteria:\n\n* Patient is pregnant, breastfeeding, or plans to become pregnant at any time in the future.\n* Patient is unwilling or unable to use contraception during sexual intercourse for the duration of the study.\n* In the event that patient becomes pregnant during or after the study, they are not prepared to inactivate device for the whole period of the pregnancy.\n* Any significant medical condition that, in the opinion of the Investigator, is likely to interfere with study procedures, device operation, or likely to confound evaluation of study endpoints.\n* History of major psychiatric or personality disorder.\n* Any neurological condition that in the opinion of the investigator may interfere with normal bladder function (e.g., stroke, multiple sclerosis, Parkinson's disease, clinically significant peripheral neuropathy, or complete spinal cord injury).\n* Uncontrolled type I or type II diabetes (as defined by their routine care clinician or HBA1C ≥ 7.0).\n* History of cancer within 5 years prior to enrolment, except for a cancer that was determined to be free of systemic cancer risk, such as basal cell carcinoma.\n* Patient is taking antiplatelet and\u002For anticoagulant drugs including warfarin or newer alternatives (e.g., rivaroxaban, apixaban, dabigatran, edoxaban) which cannot be paused prior to surgery, or has a bleeding disorder that cannot be corrected prior to surgery.\n* Any clinical reason that, in the opinion of the Investigator, may compromise patient's safety during the study.\n* Currently participating in another interventional study. This excepts purely observational studies, e.g., registries.\n* Patient participation in vigorous physical activities where these cannot be restricted for a period of 6 weeks post-implantation.\n* Patient unwilling to stop any future participation in scuba diving below 10m. BMI ≥ 40kg\u002Fm2 or waist circumference \\> 127cm\n* Documented history of allergic response to titanium, zirconia, polyurethane, epoxy, or silicone.\n* Skin, orthopedic or neurological anatomical limitations at the site of implant that could prevent successful placement of an electrode or IPG. This includes active perineal sepsis or perianal sepsis (e.g., anal fistula and pilonidal sinus).\n* Knowledge of planned MRIs, diathermy, medical microwave exposure, high output ultrasonic exposure, or medical RF energy exposure.\n* Implantable neurostimulator or antennae, pacemaker or defibrillator in-situ (anywhere in body).\n\nExclusion Criteria (Urological):\n\n* Known diagnosis of interstitial cystitis or bladder pain syndrome as defined by either AUA or EAU guidelines. Diagnosis of any other chronic pelvic or regional pain syndrome\n* Documented bladder emptying syndrome including neurogenic bladder.\n* Known abnormal post void residual (\\> 100 ml).\n* Any prolapse (symptomatic or asymptomatic) currently at or below the hymenal level Known urinary tract mechanical obstruction such as urethral stricture and\u002For bladder neck contracture.\n* Current symptomatic urinary tract infection (UTI) or more than 3 culture-proven UTIs in past year.\n* Current diagnosis of vesicoureteral reflux\n* Current diagnosis of bladder stones\n* History of bladder tumour (benign or malignant) -Suspected or proven pudendal nerve entrapment syndrome. In patients with co- existent chronic pelvic pain and urinary incontinence symptoms, Nantes criteria will be used for screening. Patients meeting essential criteria will be excluded from the study.\n* Suspected or proven severe pudendal nerve damage at discretion of clinician with or without specialist investigations\n* Any previous experience of pudendal nerve stimulation using an implanted lead.\n* Previous failure of SNM therapy (based on implantation; failed test phase is not an exclusion)\n* Major previous urethral or bladder surgery (excisional or reconstructive) at discretion of investigator\n* SUI surgery e.g. urethral slings, tapes, and bulking agents colposuspension within last 2 years; \\> 2 years at discretion of investigator\n* Prolapse surgery e.g. colposuspension \u002F colporrhaphy within last 12 months with current confirmation via pelvic exam of no recurrence \\> or = to Stage 2 pelvic organ prolapse\n* Previous use of bladder botox injections within last 6 months","22 Years",{"count":150,"type":21},86,[152],"NA","Exploratory safety and feasibility study of personalized adaptive pudendal neuromodulation for mixed urinary incontinence and extended indications using an implanted (Picostim™ II) system.",[155,28,156,157],"Mixed Urinary Incontinence","Chronic Pelvic Pain","Urge Urinary Incontinence","2026-05-13",{"date":160,"type":37},"2026-05-15",{"date":162,"type":37},"2025-06-24",{"date":164,"type":21},"2030-01",{"name":166,"class":44},"Amber Therapeutics Ltd",7,{"id":169,"slug":170,"hasResults":11,"nctId":171,"briefTitle":172,"officialTitle":173,"acronym":30,"eligibilityCriteria":174,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":175,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":177,"conditions":178,"keywords":179,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":181,"lastUpdatePostDateStruct":182,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":86},"100635530","baseline-knowledge-of-stress-urinary-incontinence-among-urogynecology-patients-100635530","NCT07553884","Baseline Knowledge of Stress Urinary Incontinence Among Urogynecology Patients","Knowledge, Awareness, and Understanding of Stress Urinary Incontinence in Patients Attending a Urogynecology Clinic","Inclusion Criteria:\n\n* Participants are patients referred to Sunnybrook Health Sciences Centre Urogynecology Clinics with the condition of SUI.\n* ≥ 18 years old\n* Female\n* Able to provide informed consent and communicate in English\n\nExclusion Criteria:\n\n* Under the age of 18 years\n* Urge-predominant mixed urinary incontinence or pure urinary urge incontinence\n* Inability to respond to research questionnaires in English\n* Unable to provide informed consent",{"count":176,"type":21},90,"The goal of this prospective study is to assess whether a standardized educational flyer (pamphlet) improves knowledge about stress urinary incontinence (SUI) in adult females attending a urogynecology clinic. It will also explore how participant characteristics relate to treatment preferences.\n\nThe main questions it aims to answer are:\n\nDoes reading a standardized SUI patient information flyer improve participants' knowledge of SUI? How do patient characteristics influence treatment preferences for SUI?\n\nParticipants will:\n\nComplete a self-administered questionnaire assessing knowledge of SUI, including its definition, pathophysiology, risk factors, natural history, and treatment options (this questionnaire is not part of standard care).\n\nReview a standardized SUI educational flyer during their clinic visit. Complete the same questionnaire again after reading the pamphlet to assess any change in knowledge.\n\nQuestionnaire scores before and after reading the flyer will be compared. Secondary outcomes include participant characteristics and reported treatment preferences.",[28],[180],"prospective cohort","2026-04-20",{"date":183,"type":37},"2026-04-28",{"date":185,"type":21},"2026-04-30",{"date":187,"type":21},"2026-07-31",{"name":189,"class":85},"Sunnybrook Health Sciences Centre",{"id":191,"slug":192,"hasResults":11,"nctId":193,"briefTitle":194,"officialTitle":194,"acronym":4,"eligibilityCriteria":195,"healthyVolunteers":11,"sex":52,"minAge":196,"maxAge":197,"enrollmentInfo":198,"targetDuration":4,"studyType":22,"phases":200,"briefSummary":201,"conditions":202,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":203,"lastUpdatePostDateStruct":204,"startDateStruct":206,"completionDateStruct":208,"leadSponsor":210,"locationsCount":4},"100635264","the-effect-of-periurethral-injection-of-platelet-rich-plasma-versus-mid-urethral-sling-in-treatment-of-stress-urinary-incontinence--a-randomized-clinical-trial-100635264","NCT07550426","The Effect of Periurethral Injection of Platelet Rich Plasma Versus Mid-urethral Sling in Treatment of Stress Urinary Incontinence : a Randomized Clinical Trial","Inclusion Criteria:\n\n* stress urinary incontinence identified by urodynamic study\n* patient agreement to undergo surgical treatment\n\nExclusion Criteria:\n\n* previous GUS operation\n* evidence of detrusor overactivity urinary system\n* presence of pelvic organ prolapse\n* malignancies of genitourinary system\n* history of hemorrhagic disorders , on anti platelet treatment , uncontrolled diabetes mellitus .","26 Years","66 Years",{"count":199,"type":21},42,[152],"this study used to compare efficacy between platelet rich plasma periurethral injection versus mid urethral sling ( trans obturator tape ) in treatment of stress urinary incontinence",[28],"2026-04-18",{"date":205,"type":37},"2026-04-24",{"date":207,"type":21},"2026-04-15",{"date":209,"type":21},"2027-12-30",{"name":211,"class":85},"Ain Shams University",{"id":213,"slug":214,"hasResults":11,"nctId":215,"briefTitle":216,"officialTitle":217,"acronym":218,"eligibilityCriteria":219,"healthyVolunteers":11,"sex":17,"minAge":148,"maxAge":4,"enrollmentInfo":220,"targetDuration":4,"studyType":22,"phases":222,"briefSummary":223,"conditions":224,"keywords":225,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":230,"completionDateStruct":232,"leadSponsor":234,"locationsCount":236},"100590540","a-study-to-assess-the-safety-and-effectiveness-of-the-uroactive-artificial-urinary-sphincter-aus-100590540","NCT06968741","A Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter (AUS)","Study to Assess the Safety and Effectiveness of the UrOActive® Artificial Urinary sPHincter In the treAtment of Stress Urinary Incontinence in Men","SOPHIA2","Key Inclusion Criteria:\n\n* Male subjects aged ≥ 22 years old\n* Able to read, comprehend and willing to sign an informed consent form\n* Primary diagnosis of stress urinary incontinence for at least 6 months, as assessed by the investigator\n* Appropriate surgical candidate with no medical or mental condition that would interfere with study procedures or confound study outcomes as assessed by the investigator\n\nKey Exclusion Criteria:\n\n* Currently enrolled or plans to enroll in another investigational device or clinical drug trial or has completed an investigational study (for urinary incontinence) in the past 3 months prior to informed consent\n* Poor candidate for surgical procedures and\u002For anesthesia, as determined by investigator\n* Currently implanted with an Active Implantable Medical Device (AIMD)\n* Symptoms or diagnosis of urge incontinence or mixed incontinence (MI) with a predominant urgency component, as assessed by the investigator",{"count":221,"type":21},140,[152],"Prospective, multicenter, single-arm study",[28],[102,226],"Artificial urinary sphincters","2026-03-26",{"date":229,"type":37},"2026-03-27",{"date":231,"type":37},"2025-05-19",{"date":233,"type":21},"2031-12",{"name":235,"class":44},"UroMems SAS",21,{"id":238,"slug":239,"hasResults":11,"nctId":240,"briefTitle":241,"officialTitle":242,"acronym":243,"eligibilityCriteria":244,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":245,"enrollmentInfo":246,"targetDuration":4,"studyType":22,"phases":248,"briefSummary":249,"conditions":250,"keywords":256,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":263,"lastUpdatePostDateStruct":264,"startDateStruct":266,"completionDateStruct":268,"leadSponsor":270,"locationsCount":86},"100598777","dynamic-neuromuscular-stabilization-vs-pelvic-floor-muscle-training-in-women-with-stress-urinary-incontinence-100598777","NCT07075900","Dynamic Neuromuscular Stabilization vs Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence","Comparison of Effects of Dynamic Neuromuscular Stabilization Training and Pelvic Floor Muscle Training in Women With Stress Urinary Incontinence: A Randomized Controlled Trial","DYNA-SUI","Inclusion Criteria:\n\n* Female participants aged between 18 and 65 years\n* Diagnosed with stress urinary incontinence or stress-dominant mixed urinary incontinence by a specialist physician\n* Having the ability to voluntarily contract the pelvic floor muscles\n* Literate in Turkish\n* Willing and voluntarily consenting to participate in the study\n\nExclusion Criteria:\n\n* Pregnancy\n* Presence of urgency-predominant urinary incontinence symptoms or fecal incontinence\n* Inability to understand or cooperate with assessment procedures\n* Presence of any neurological or rheumatological disease\n* Severe cardiac or pulmonary disease\n* Uncontrolled diabetes mellitus or hypertension\n* Chronic liver and\u002For kidney failure\n* Advanced pelvic organ prolapse (greater than grade 2)\n* History of abdominal or pelvic surgery (including cesarean section) within the past year\n* History of spinal surgery\n* Current urinary tract infection\n* History of pelvic radiation therapy\n* Presence of spinal deformity\n* History of acute low back pain within the past 4-6 weeks\n* Receiving pelvic floor muscle training within the past three months","65 Years",{"count":247,"type":21},51,[152],"This randomized controlled trial aims to compare the pre- and post-treatment effects of Dynamic Neuromuscular Stabilization (DNS) training and Pelvic Floor Muscle Training (PFMT) on pelvic floor muscle function, pelvic floor morphometry, urinary symptoms, quality of life, sexual function, and physical activity levels in women with stress urinary incontinence (SUI).\n\nParticipants diagnosed with SUI by a specialist physician will be randomly assigned to one of three groups: DNS, PFMT, or a control group. Both DNS and PFMT interventions will be delivered as 12-week home exercise programs, performed five days a week and at least three times per day. To support adherence, participants will use an exercise diary. In addition, participants in the DNS and PFMT groups will attend the clinic twice a week for supervised sessions led by a physiotherapist.\n\nThe control group will receive a brochure containing lifestyle and bladder health recommendations but will not engage in any structured exercise program.",[28,251,252,253,254,255],"Dynamic Neuromuscular Stabilization","Pelvic Floor Muscle Training","Muscle Morphology","Urinary Symptoms","Quality of Life",[257,258,259,260,261,262],"stress urinary incontinence","dynamic neuromuscular stabilization","pelvic floor muscle training","physical activity","quality of life","muscle morphology","2026-03-24",{"date":265,"type":37},"2026-03-25",{"date":267,"type":37},"2025-07-16",{"date":269,"type":21},"2026-12-30",{"name":271,"class":85},"Izmir Katip Celebi University",{"id":273,"slug":274,"hasResults":11,"nctId":275,"briefTitle":276,"officialTitle":277,"acronym":278,"eligibilityCriteria":279,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":280,"targetDuration":4,"studyType":22,"phases":282,"briefSummary":283,"conditions":284,"keywords":285,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":288,"lastUpdatePostDateStruct":289,"startDateStruct":290,"completionDateStruct":292,"leadSponsor":294,"locationsCount":86},"100564011","the-impact-of-breathing-training-on-ppsui-a-randomized-controlled-trial-100564011","NCT06623617","The Impact of Breathing Training on PPSUI: A Randomized Controlled Trial","The Effect of Breathing Training on Postpartum Stress Urinary Incontinence : A Randomized Controlled Trial","PPSUI","Inclusion Criteria:\n\n1. Age: ≥18years\n2. 6 weeks to 6 months postpartum\n3. Diagnosed with postpartum stress urinary incontinence (PPSUI) by a pelvic floor rehabilitation specialist\n\nExclusion Criteria:\n\n1. Diabetes mellitus\n2. Body mass index (BMI) \\>30 kg\u002Fm²\n3. Cardiopulmonary or renal dysfunction\n4. Neurological disorders\n5. Pelvic organ prolapse exceeding stage II\n6. History of lumbopelvic surgery\n7. Lumbopelvic pain\n8. Concurrent treatments that may interfere with study outcomes\n9. Professional athletes\n10. Current pregnancy\n\nWithdrawal Criteria:\n\n1. Failure to complete follow-up assessments\n2. Loss of contact with participants\n\nTermination Criteria:\n\n1. Immediate discontinuation if participants experience dizziness, chest tightness, palpitations, or dyspnea during training\n2. Inability to continue intervention due to health issues (e.g., severe complications)\n3. Pregnancy occurring during the intervention period\n4. Non-compliance with prescribed breathing exercises\n5. Participant-initiated withdrawal from the study",{"count":281,"type":21},58,[152],"\\*\\*Clinical Trial\\*\\* This clinical trial aims to investigate the clinical therapeutic effects of breathing training on postpartum stress urinary incontinence (PPSUI).\n\nParticipants will:\n\nAll participants will receive standard postpartum care and recovery guidance, including routine examinations, health counseling, basic postpartum recovery recommendations, and educational information.\n\nControl Group: Participants will receive conventional pelvic floor rehabilitation therapy, which may include one or a combination of the following: magnetic stimulation therapy, electromyographic biofeedback therapy, and manual therapy. The specific treatment methods and frequency will be determined based on individual patient conditions.\n\nIntervention Group: In addition to the same pelvic floor rehabilitation therapy as the control group, participants will receive breathing training. Before each session, participants will empty their bladder. The breathing training will be conducted under researcher supervision and guidance, with each session lasting 20 minutes, administered once daily, three times per week for 6 weeks. Participants are encouraged to perform the training in the hospital under researcher supervision. Those unable to attend in-person sessions may conduct home-based training after mastering the technique and must report their training status to researchers afterward. Researchers will monitor weekly training completion and provide timely reminders to ensure adherence. If dizziness or difficulty breathing occurs during training, participants must immediately discontinue the session.",[28],[286,287],"Postpartum Stress Urinary Incontinence","Breathing training","2026-03-23",{"date":229,"type":37},{"date":291,"type":37},"2025-05-01",{"date":293,"type":21},"2026-05-01",{"name":295,"class":85},"Jie Li",{"id":297,"slug":298,"hasResults":11,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":22,"phases":306,"briefSummary":307,"conditions":308,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":309,"lastUpdatePostDateStruct":310,"startDateStruct":312,"completionDateStruct":314,"leadSponsor":316,"locationsCount":4},"100628814","efficacy-and-safety-of-intravaginal-ems-treatments-in-women-with-exclusive-or-predominant-stress-urinary-incontinence-100628814","NCT07466537","Efficacy and Safety of Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence","Efficacy and Safety of 6 Intravaginal EMS Treatments in Women With Exclusive or Predominant Stress Urinary Incontinence","STONE","Inclusion Criteria:\n\n* Women with minimum age of 18 years .\n* Documented clinical diagnosis of exclusive or predominant stress urinary incontinence.\n* Willingness to comply with study procedures and follow-up visits.\n* Signed informed consent to participate in the study.\n* BMI \\\u003C\u002F= 30.\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\n* Impaired immune system due to immunosuppressive diseases such as AIDS and HIV 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 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 treatment study\n* Active urinary tract or vaginal infection\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\n* Untreated symptomatic urinary tract infection\n* Unevaluated hematuria\n* Not available for follow-up in 6 months\n* Participation in other research trials that could influence results of this study",{"count":305,"type":21},15,[152],"The investigator wants to evaluate the efficacy of a specific intravaginal Electrical Muscle Stimulation (EMS), in the treatment of exclusive or predominant stress urinary incontinence (SUI) symptoms in women. The investigator's aim is to determine the device's impact (the device is VTone) on reducing urinary incontinence episodes and on improving women's quality of life.",[28],"2026-03-11",{"date":311,"type":37},"2026-03-13",{"date":313,"type":21},"2026-03-30",{"date":315,"type":21},"2027-03-01",{"name":317,"class":85},"IRCCS San Raffaele",{"id":319,"slug":320,"hasResults":11,"nctId":321,"briefTitle":322,"officialTitle":323,"acronym":4,"eligibilityCriteria":324,"healthyVolunteers":11,"sex":52,"minAge":325,"maxAge":4,"enrollmentInfo":326,"targetDuration":4,"studyType":22,"phases":328,"briefSummary":329,"conditions":330,"keywords":331,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":332,"lastUpdatePostDateStruct":333,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":86},"100626845","stress-urinary-incontinence-for-female-patients-cgm-muit-2301-100626845","NCT07440927","Stress Urinary Incontinence for Female Patients (CGM MUIT-2301)","A Multi-center, Prospective, Randomized, Double-blind, Sham Device Controlled Clinical Trial to Compare and Evaluate the Efficacy and Safety of the Use an Investigational Device (Model Name CGM MUIT-2301) and Sham Device (Model Name CGM MUIT-2301C) for Female Patients With Stress Urinary Incontinence","Inclusion Criteria:\n\n* Patients with urine leakage of ≥1 g on the standardized pad test\n\nExclusion Criteria:\n\n* Patients with mixed urinary incontinence with predominant urgency urinary incontinence\n* Patients with stress urinary incontinence\n* Patients with overflow urinary incontinence","19 Years",{"count":327,"type":21},96,[152],"This study is a multicenter, prospective, randomized, double-blind, sham-controlled clinical trial conducted in female patients with stress urinary incontinence.",[28],[28],"2026-02-25",{"date":334,"type":37},"2026-02-27",{"date":336,"type":37},"2024-12-13",{"date":338,"type":21},"2026-09-30",{"name":340,"class":44},"Ceragem Clinical Inc.",{"id":342,"slug":343,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":348,"enrollmentInfo":349,"targetDuration":4,"studyType":22,"phases":351,"briefSummary":352,"conditions":353,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":355,"lastUpdatePostDateStruct":356,"startDateStruct":358,"completionDateStruct":360,"leadSponsor":361,"locationsCount":86},"100593654","dynamic-neuromuscular-stabilization-exercises-in-women-with-urinary-incontinence-100593654","NCT07009249","Dynamic Neuromuscular Stabilization Exercises in Women With Urinary Incontinence","Effects of Dynamic Neuromuscular Stabilization Exercises on Urinary Symptoms and Pelvic Floor Muscle Functions in Women With Stress Urinary Incontinence: A Single-Blind Non-Inferiority Clinical Study","Inclusion Criteria:\n\n* Female gender,\n* Voluntary participation in the study,\n* Aged between 18 and 62 years,\n* Ability to read and write in Turkish,\n* No mental disorders that would impair cooperation or comprehension,\n* Complaint of stress urinary incontinence (SUI) or stress-predominant mixed urinary incontinence.\n\nExclusion Criteria:\n\n* Prior history of pelvic floor muscle training,\n* Presence of any neurological disorder,\n* Pelvic organ prolapse stage II or higher,\n* Presence of fecal incontinence,\n* Pregnancy,\n* Lower extremity conditions that may affect pelvic alignment (e.g., leg length discrepancy, total hip arthroplasty),\n* Active lower urinary tract infection,\n* Presence of respiratory disorders such as chronic obstructive pulmonary disease or asthma,\n* History of hysterectomy.","62 Years",{"count":350,"type":21},62,[152],"Stress urinary incontinence (SUI) is defined by the International Continence Society as the complaint of involuntary leakage of urine during physical exertion, including sports activities, or during sneezing or coughing. In continent women, an automatic response-namely, a reflex pelvic floor muscle (PFM) contraction, also known as pre-contraction-occurs either prior to or during physical exertion. Although there is strong evidence supporting the effectiveness of pelvic floor muscle training (PFMT) in the treatment of SUI, there has been a growing interest in exploring alternative exercise-based interventions.\n\nDynamic Neuromuscular Stabilization (DNS) is a manual and rehabilitative approach developed by Professor Pavel Kolar. It is grounded in the scientific principles of developmental kinesiology and aims to optimize the function of the movement system. Currently, DNS is successfully employed in the rehabilitation of various neurological, musculoskeletal, pediatric, and sports-related injuries. DNS incorporates the subconscious and synergistic activation of the deep core muscles responsible for intra-abdominal pressure (IAP) regulation and spinal stability-namely, the diaphragm, transversus abdominis, multifidus, and pelvic floor muscles-as well as the global musculature.\n\nConsidering the potential mechanisms of DNS, we hypothesize that DNS exercises, through IAP regulation directed toward the pelvic cavity and contributing to stabilization, could serve as an effective and innovative approach for women with SUI.\n\nThe hypotheses of this study are as follows:\n\nH1.1: DNS is as effective as PFMT in reducing urinary symptoms in women with SUI.\n\nH1.2: DNS is as effective as PFMT in improving PFM function in women with SUI.",[28,251,252,254,354],"Biofeedback Training","2026-02-12",{"date":357,"type":37},"2026-02-17",{"date":359,"type":37},"2025-05-21",{"date":293,"type":21},{"name":362,"class":85},"Izmir University of Economics",{"id":364,"slug":365,"hasResults":11,"nctId":366,"briefTitle":367,"officialTitle":368,"acronym":369,"eligibilityCriteria":370,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":371,"enrollmentInfo":372,"targetDuration":4,"studyType":22,"phases":374,"briefSummary":375,"conditions":376,"keywords":377,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":379,"lastUpdatePostDateStruct":380,"startDateStruct":382,"completionDateStruct":384,"leadSponsor":386,"locationsCount":86},"100615246","mesh-free-versus-mesh-based-surgery-for-female-stress-urinary-incontinence-a-prospective-comparison-of-pubo-urethral-ligament-plication-and-transobturator-tape-100615246","NCT07290114","Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape","Mesh-Free Versus Mesh-Based Surgery for Female Stress Urinary Incontinence: A Prospective Comparison of Pubo-Urethral Ligament Plication and Transobturator Tape With Short-Term Patient-Centered Outcomes","PLP-TOT","Inclusion Criteria:\n\nFemale patients aged 18-80 years\n\nClinical diagnosis of stress urinary incontinence\n\nFailure of conservative management (pelvic floor exercises or medical therapy)\n\nDesire to undergo surgical treatment (PLP or TOT)\n\nAbility to provide informed consent\n\nWillingness to attend postoperative follow-up visits\n\nExclusion Criteria:\n\n* Mixed urinary incontinence with predominant urge symptoms\n\nActive urinary tract infection\n\nPelvic organ prolapse ≥ stage II\n\nPrevious anti-incontinence surgery\n\nNeurological diseases affecting bladder function\n\nPregnancy or planning pregnancy during follow-up\n\nUncontrolled diabetes, bleeding disorders, or contraindications to surgery\n\nUse of medications affecting bladder function (e.g., anticholinergics)\n\nInability to provide informed consent","80 Years",{"count":373,"type":21},147,[152],"This prospective clinical study aims to compare the short-term effectiveness, safety, and patient-reported outcomes of two surgical techniques used for the treatment of female stress urinary incontinence (SUI): Pubo-Urethral Ligament Plication (PLP), a mesh-free native tissue repair method, and the Transobturator Tape (TOT) procedure, a commonly used mesh-based mid-urethral sling technique. The study evaluates continence improvement, perioperative and postoperative complications, operative time, hospital stay, postoperative pain, and patient satisfaction. The goal is to provide evidence on whether a mesh-free surgical option such as PLP can offer comparable outcomes to mesh-based TOT, particularly for patients seeking alternatives to synthetic materials.",[28],[378],"Stress Urinary Incontinence, Pubo-Urethral Ligament Plication, PLP, Transobturator Tape, TOT, Mesh-free surgery, Midurethral sling","2025-12-04",{"date":381,"type":37},"2025-12-18",{"date":383,"type":37},"2025-01-13",{"date":385,"type":21},"2026-09",{"name":387,"class":85},"Mehmet Incebıyik",{"id":389,"slug":390,"hasResults":11,"nctId":391,"briefTitle":392,"officialTitle":392,"acronym":4,"eligibilityCriteria":393,"healthyVolunteers":94,"sex":52,"minAge":123,"maxAge":394,"enrollmentInfo":395,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":397,"conditions":398,"keywords":399,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":403,"lastUpdatePostDateStruct":404,"startDateStruct":406,"completionDateStruct":408,"leadSponsor":410,"locationsCount":86},"100599194","the-effect-of-different-delivery-positions-on-pelvic-floor-function-100599194","NCT07081321","The Effect of Different Delivery Positions on Pelvic Floor Function.","Inclusion Criteria:\n\n1. Age 20-35 years old\n2. Singleton, cephalic position, full-term primipara;\n3. Cephalopelvic disproportion;\n4. Expected fetal weight\\\u003C 4000g;\n5. Intended vaginal delivery in our hospital;\n6. Voluntary participation of study subjects.\n\nExclusion Criteria:\n\n1. Pelvic floor organ prolapse beyond the hymen limbus;\n2. Combined with uncontrolled medical diseases and asthma, allergic rhinitis and constipation before pregnancy;\n3. Presence of contraindications to vaginal delivery","35 Years",{"count":396,"type":21},669,"This study is a cohort clinical study. Baseline data were collected from cases recruited at pregnancy, and the eligible subjects were grouped into 3 groups according to different delivery position including supine position group, upright position group, and lateral position group. Different delivery positions along with respectively timeand obstetric conditions were recorded at delivery. Pelvic floor function assessments were performed at postpartum.",[28],[400,401,402],"Stress Urinary inconticence","Dlivery position","Pelvic Floor muscle strength","2025-11-24",{"date":405,"type":37},"2025-11-25",{"date":407,"type":21},"2025-12-07",{"date":409,"type":21},"2027-12-01",{"name":411,"class":85},"Peking University People's Hospital",{"id":413,"slug":414,"hasResults":11,"nctId":415,"briefTitle":416,"officialTitle":417,"acronym":4,"eligibilityCriteria":418,"healthyVolunteers":11,"sex":52,"minAge":419,"maxAge":4,"enrollmentInfo":420,"targetDuration":4,"studyType":22,"phases":421,"briefSummary":422,"conditions":423,"keywords":424,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":432,"locationsCount":86},"100581845","chm-for-female-stress-urinary-incontinence-100581845","NCT06855602","CHM for Female Stress Urinary Incontinence","A Single Arm Pilot Study of the Chinese Herbal Medicine Formula (S-2196) for the Female Stress Urinary Incontinence (SUI)","Inclusion Criteria:\n\n* Females aged ≥55 years\n* Meet the ICUD diagnostic criteria of stress urinary incontinence\n* Measured urine leakage \\>10g in the 1-hour standard pad test\n* Understand and can follow written and verbal instructions in Chinese\n* Able to independently use and complete the electronic diary during the 1-week screening period\n* The subject is informed and voluntarily signs the informed consent form\n\nExclusion Criteria:\n\n* Patients with other types of urinary incontinence, such as neurogenic urinary incontinence, urge urinary incontinence, and overflow urinary incontinence.\n* Subjects with the following urogenital system diseases (vesicoureteral reflux, detrusor instability, congenital urethral abnormalities, urinary tract infection or hematuria indicated by routine urinalysis or urine culture, urogenital fistula, urethral diverticulum, bladder stones, urinary system tumors, abnormal vaginal bleeding, pelvic malignant tumors, uterine prolapse grade II or above).\n* History of SUI surgery or complex urethral surgery, including previous transvaginal tension-free mid-urethral sling, anterior wall prolapse repair, urethral injection therapy, etc.\n* Previous pelvic radiotherapy, radical surgery for pelvic malignant tumors, and pelvic floor surgery.\n* Currently receiving or needing to continue treatment related to urinary incontinence, including pelvic floor muscle training, physical therapy, pessary, and medication.\n* If using medications that affect urination during the screening period (including but not limited to thiazolidinediones, sodium-glucose cotransporter 2 inhibitors, anticholinergics, alpha- and beta-adrenergic receptor antagonists, alpha- and beta-adrenergic receptor agonists, diuretic antihypertensive drugs, antihistamines, M receptor antagonists, calcium channel blockers, angiotensin-converting enzyme inhibitors, hormonal drugs, neurotransmitter drugs, intestinal flora regulating drugs, etc.), and unable to maintain a stable dose during the study period; or if considering using the above medications during the study period but not using them during the screening period.\n* Presence of neurological disorders (including but not limited to central nervous system injury, motor neuron disease, neurodegenerative diseases), diabetes, connective tissue diseases, mental disorders, hypertension (defined as long-term monitored systolic blood pressure ≥140 mmHg or diastolic blood pressure ≥90 mmHg), severe cardiovascular and cerebrovascular diseases, severe liver or kidney diseases.\n* Combined with chronic cough diseases such as chronic obstructive pulmonary disease (COPD), gastrointestinal diseases affecting drug absorption, or other chronic diseases in an unstable state.\n* History of adverse reactions to traditional Chinese medicine, or G6PD deficiency.\n* Unable to complete exercises such as walking or climbing stairs.\n* Deemed unsuitable for participation in this study by the researchers due to psychological or physical reasons.","55 Years",{"count":305,"type":21},[152],"This single-arm, open-label pilot clinical trial will test the hypothesis that S-2196, a Chinese herbal medicine formula, will show efficacy and safety in alleviating the amount and frequency of urinary incontinence in female individuals with stress urinary incontinence. All participants (n=15) will receive 1 week of screening, 2 weeks of intervention, and 1 week of follow-up.",[28],[257,425],"female","2025-11-17",{"date":428,"type":37},"2025-11-20",{"date":430,"type":37},"2024-10-21",{"date":133,"type":21},{"name":433,"class":85},"Hong Kong Baptist University",{"id":435,"slug":436,"hasResults":11,"nctId":437,"briefTitle":438,"officialTitle":438,"acronym":4,"eligibilityCriteria":439,"healthyVolunteers":11,"sex":52,"minAge":4,"maxAge":4,"enrollmentInfo":440,"targetDuration":4,"studyType":22,"phases":442,"briefSummary":443,"conditions":444,"keywords":446,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":451,"lastUpdatePostDateStruct":452,"startDateStruct":454,"completionDateStruct":456,"leadSponsor":458,"locationsCount":4},"100607317","the-effectiveness-of-combined-pelvic-floor-muscle-training-and-vaginal-oestrogen-therapy-in-postmenopausal-women-with-stress-urinary-incontinence-100607317","NCT07186985","The Effectiveness of Combined Pelvic Floor Muscle Training and Vaginal Oestrogen Therapy in Postmenopausal Women With Stress Urinary Incontinence","Inclusion Criteria:\n\n* Patients diagnosed with stress urinary incontinence.\n* Women who have been naturally postmenopausal for at least 1 year or are postmenopausal due to bilateral oophorectomy (surgical removal of both ovaries).\n* Have had sexual intercourse to ensure feasibility of urogenital tract examination and assessment.\n* Patients who consent to participate in the study and comply with the treatment protocol, including performing pelvic floor muscle training (PFMT) and completing topical vaginal estrogen therapy.\n\nExclusion Criteria:\n\n* Patients with concomitant neurological disorders, urinary tract infections, prior pelvic radiotherapy, or congenital malformations of the lower urinary tract.\n* Genitourinary malformations or fistulas causing continuous urinary incontinence.\n* Genitourinary cancers or tumors of the urinary tract.\n* History of spinal cord injury or central nervous system injury affecting the centers that control urination.\n* Patients previously treated for stress urinary incontinence (SUI) (surgery, medications, exercises).\n* Patients with severe heart disease, coronary artery disease, or myocardial ischemia.\n* Patients with pelvic organ prolapse stage III or higher, unexplained vaginal bleeding, confirmed or suspected breast cancer, or vaginitis.\n* Presence of premalignant factors or suspected steroid-dependent cancers such as endometrial carcinoma.\n* History of or current hepatic tumors, or progressive liver or biliary disease.\n* Coagulation\u002Fthrombotic disorders, or a history of thromboembolism or stroke.\n* Severe hypertriglyceridemia.\n* Hypersensitivity to any component of vaginally administered estrogen products.\n* The patient or family members are unable to use a smartphone (Android or iOS) to participate in the monitoring program.\n* The patient does not agree to participate in the study.",{"count":441,"type":21},115,[152],"The objective of this clinical trial is to investigate whether the combination of pelvic floor muscle training (PFMT) and topical estrogen is more effective in treating stress urinary incontinence (SUI) in postmenopausal women compared to topical estrogen alone. The trial will also analyze factors related to the outcomes of the combined therapy. The key questions this trial aims to answer are:\n\n* Does the combination of PFMT and topical estrogen improve symptoms of stress urinary incontinence in postmenopausal women better than topical estrogen alone?\n* Which factors are associated with the effectiveness of the combined therapy?\n\nResearchers will compare the group receiving the combined therapy (pelvic floor muscle training plus topical estrogen) with the group receiving topical estrogen alone to determine whether adding PFMT to estrogen therapy provides additional treatment benefits for SUI in postmenopausal women.\n\nParticipants will:\n\n\\- Be randomly assigned to one of two groups:\n\nGroup 1: Undergo a pelvic floor muscle training (PFMT) program combined with topical estrogen therapy (e.g., vaginal cream\u002Fapplication,...).\n\nGroup 2: Receive topical estrogen therapy alone (e.g., vaginal cream\u002Fapplication,...).\n\n* Follow the assigned intervention protocol for a specified duration.\n* Attend regular clinic visits for clinical examinations, assessment of incontinence severity, and related measurements.\n* Monitor and record their incontinence symptoms and the frequency of urine leakage during daily activities.",[28,445],"Postmenopausal Women",[447,448,252,449,450],"stress urinary incontinence (SUI)","postmenopausal women","Vaginal Oestrogen","Pelvic floor rehabilitation","2025-09-18",{"date":453,"type":37},"2025-09-22",{"date":455,"type":21},"2025-11-01",{"date":457,"type":21},"2027-02-28",{"name":459,"class":85},"Hanoi Medical University",{"id":461,"slug":462,"hasResults":11,"nctId":463,"briefTitle":464,"officialTitle":465,"acronym":4,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":52,"minAge":467,"maxAge":18,"enrollmentInfo":468,"targetDuration":4,"studyType":22,"phases":470,"briefSummary":471,"conditions":472,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":474,"lastUpdatePostDateStruct":475,"startDateStruct":477,"completionDateStruct":479,"leadSponsor":481,"locationsCount":86},"100604107","effect-of-knack-pelvic-floor-contraction-on-sexual-dysfunction-100604107","NCT07145216","Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction","Effect of Knack Pelvic Floor Contraction on Sexual Dysfunction in Females With Stress Urinary Incontinence","Inclusion Criteria:\n\n1. Females with mild and moderate degrees of SUI according to Incontinence Severity Index score (mild: 1-2; and moderate: 3-4 scoring).\n2. Their ages will range from 25 to 45 years old.\n3. Their body mass index (BMI) will be less than 30 kg\u002Fm2.\n4. They are multiparous women.\n5. Females complain of sexual disorders related to SUI, identified by an FSFI score of less than 28.1\n6. They have a sedentary lifestyle.\n\nExclusion Criteria:\n\n1. Severe degree of SUI.\n2. Other types of urinary incontinence, such as urge urinary incontinence and mixed urinary incontinence.\n3. Other neurological diseases such as myasthenia gravis and Parkinsonism.\n4. History of pelvic fractures.\n5. Menopausal women.\n6. Females with pelvic organ prolapse (POP).","25 Years",{"count":469,"type":21},40,[152],"This study aims to investigate the effect of knack pelvic floor contraction on sexual dysfunction in females with stress urinary incontinence.",[28,473],"Sexual Dysfunction","2025-08-21",{"date":476,"type":37},"2025-08-28",{"date":478,"type":21},"2025-09-01",{"date":480,"type":21},"2026-01-30",{"name":482,"class":85},"Cairo University",{"id":484,"slug":485,"hasResults":11,"nctId":486,"briefTitle":487,"officialTitle":488,"acronym":489,"eligibilityCriteria":490,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":22,"phases":493,"briefSummary":494,"conditions":495,"keywords":496,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":506,"lastUpdatePostDateStruct":507,"startDateStruct":509,"completionDateStruct":511,"leadSponsor":513,"locationsCount":86},"100600874","managing-impact-related-leakage-during-exercise-using-intravaginal-support-100600874","NCT07103161","Managing Impact-related Leakage During Exercise Using Intravaginal Support","Does a Regular Tampon or Intravaginal Pessary Mitigate Urine Leakage While Running Among Females Who Experience Exercise-induced Urinary Incontinence?","MILES","Inclusion Criteria:\n\n* Age \\>18 years of age\n* Participate in any exercise or sport modality involving running or brisk walking\n* Experiences urine leakage during running or brisk walking\n* Speak and read English or French\n\nExclusion Criteria:\n\n* No urine leakage in the first laboratory assessment (baseline \u002F no intervention)\n* Currently pregnant or have been pregnant in the previous 6 months\n* Had or have had cardiac, pulmonary, metabolic and\u002For neurological conditions\n* History of incontinence surgery\n* Hysterectomy\n* Symptoms consistent with urgency incontinence only\n* Experience pain with tampon use or during gynecologic examinations",{"count":492,"type":21},30,[152],"The goal of this study is to evaluate the effectiveness of using a regular menstrual tampon or a Uresta pessary to reduce urine leakage associated with running-induced stress urinary incontinence (RI-SUI) in females aged 18 and older. Secondly, the study aims to assess whether either intervention mitigates transient changes in pelvic morphology that occur following a single running bout. Lastly, we aim to evaluate whether participants continue using either intervention during running over the 4-week period following their in-lab participation. The hypotheses are:\n\nHypothesis 1: Among females with RI-SUI, both a tampon and pessary used during a single running bout will reduce urinary leakage symptoms, with greater symptom reduction observed when using the pessary.\n\nHypothesis 2: Participants will report high satisfaction and perceived symptom improvement with both the tampon and pessary, with higher satisfaction and greater improvement reported for the pessary.\n\nHypothesis 3: Both the tampon and pessary will reduce pelvic floor strain incurred by the end of the run, as evidenced by less bladder neck descent, levator plate lengthening, and levator hiatus area increasing relative to that observed when no tampon or pessary is used.\n\nHypothesis 4: A greater proportion of participants will report continued use of the pessary compared to the tampon over the 4-week post-lab period, with higher frequency of use and fewer reported discontinuations.\n\nWe will perform within-subject comparisons against baseline values to determine the effect of each intervention on RI-SUI symptoms and pelvic organ support.\n\nParticipants will complete a baseline questionnaire to collect demographic information and assess incontinence severity. They will then attend three laboratory visits within a 10-day period. At each visit, bladder volume will be standardized to between 100 and 200mL, then the participant will undergo three-dimensional (3D) transperineal ultrasound imaging conducted in a standing position. Following imaging, participants will complete a treadmill protocol consisting of 25-minutes running at a moderately difficult pace (rated at 13 - 14 on the Borg Perceiver Rate of Exertion scale), followed by 5 minutes of running at a higher intensity pace. During the run, participants will be asked at 5 minute intervals whether they experienced any urine leakage and to report their perceived amount of leakage. The ultrasound image protocol will be repeated immediately after the run.\n\nParticipants will be allowed to keep the pessary and will be contacted 4-weeks after the final visit to evaluate whether or not they continued use of a tampon or the pessary, and, if so, we will ask them to report their satisfaction with the intervention(s) they used.",[28],[257,497,498,499,500,501,502,503,504,505],"conservative treatment","pelvic floor strain","pessary","bladder support device","urinary symptoms","tampon","urine leakage","urine leakage with exercise","urine leakage with running","2025-07-31",{"date":508,"type":37},"2025-08-05",{"date":510,"type":37},"2022-09-13",{"date":512,"type":21},"2026-03",{"name":514,"class":85},"University of Ottawa",{"id":516,"slug":517,"hasResults":11,"nctId":518,"briefTitle":519,"officialTitle":520,"acronym":521,"eligibilityCriteria":522,"healthyVolunteers":94,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":523,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":525,"conditions":526,"keywords":4,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":527,"lastUpdatePostDateStruct":528,"startDateStruct":530,"completionDateStruct":532,"leadSponsor":534,"locationsCount":4},"100584258","pfu-vs-uds-in-sui-100584258","NCT06886997","PFU vs. UDS in SUI","Pelvic Floor Ultrasound Versus Urodynamic Studies in Evaluating Women With Stress Urinary Incontinence","UDS - PFU","Inclusion Criteria:\n\n* Aged ≥ 18 years\n\nExclusion Criteria:\n\n* Medical history of neurological disorders, cognitive disorders, dementia, Alzheimer's disease, or uncontrolled DM.\n* Surgical history of continence or prolapse procedure.\n* Examination showing anterior or middle compartment decent with POP-Q staging greater than stage 1, or urogenital fistula.\n* Known lower urinary tract or genital tract anomalies or tumors.",{"count":524,"type":21},50,"The goal of this observational stury is to test the diagnostic accuracy of Pelvic Floor Ultrasound in evaluating women with stress urinary incontinence compared to the reference standard Urodynamic Studies. The main question it aims to answer is:\n\nIs Pelvic floor ultrasound as accurate as urodynamic studies in diagnosis of stress urinary incontinence?",[28],"2025-05-18",{"date":529,"type":37},"2025-05-20",{"date":531,"type":21},"2025-06-01",{"date":533,"type":21},"2025-12-01",{"name":211,"class":85},{"id":536,"slug":537,"hasResults":11,"nctId":538,"briefTitle":539,"officialTitle":540,"acronym":541,"eligibilityCriteria":542,"healthyVolunteers":94,"sex":52,"minAge":53,"maxAge":543,"enrollmentInfo":544,"targetDuration":4,"studyType":98,"phases":4,"briefSummary":546,"conditions":547,"keywords":553,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":559,"completionDateStruct":561,"leadSponsor":563,"locationsCount":86},"100587824","elastographic-assessment-of-suburethral-tissue-in-continent-and-incontinent-women-100587824","NCT06933407","Elastographic Assessment of Suburethral Tissue in Continent and Incontinent Women","This Study Investigates the Role of Strain Elastography in Assessing Paraurethral Tissue Elasticity in Continent and Incontinent Pre- and Postmenopausal Women. It Also Evaluates the Predictive Value of Strain Elastography Compared to Other Pelvic Imaging Modalities, Including Conventional Ultrasound Examinations, in Supporting Treatment Decision-making for Urinary Incontinence.","SE-inc1","Inclusion Criteria:\n\n* Clinical diagnosis of stress urinary incontinence (SUI) based on patient history, physical examination, and\u002For urodynamic assessment.\n\nExclusion Criteria:\n\n* Pelvic malignancy or history of pelvic radiation therapy\n* Urge urinary incontinence (UUI) or detrusor overactivity\n* Pelvic organ prolapse (POP) stage ≥ II (based on POP-Q classification)\n* Pregnancy or recent postpartum status (less than 6 months postpartum)\n* Neurological disorders affecting bladder function\n* Recurrent urinary tract infections (UTIs) or active lower urinary tract infection\n* Inability to undergo study procedures\n* Cognitive impairment or psychiatric conditions affecting informed consent or compliance","99 Years",{"count":545,"type":21},80,"Strain elastography (SE) will be utilized as a non-invasive imaging technique to evaluate tissue elasticity and biomechanical properties in women with stress urinary incontinence (SUI) and in continent controls. The primary aim is to determine whether SE can detect differences in paraurethral tissue stiffness between these groups. Given the established role of tissue elasticity in the pathophysiology of SUI, SE will be investigated as a potential diagnostic tool in urogynecological evaluations.\n\nThis prospective cohort study will be conducted at a tertiary referral center. All participants will undergo introital two-dimensional (2D) ultrasound in the midsagittal plane at rest. SE will be performed in three predefined suburethral regions of interest (ROIs):\n\n* internal urethral orifice (IUO) level\n* midurethra (MU) level\n* external urethral orifice (EUO) level\n\nThe adipose layer (AL) between the external urethral meatus and the pubic symphysis will serve as the reference tissue, representing the softest anatomical structure in the region.\n\nDescriptive and comparative statistical analyses will be conducted to assess differences in paraurethral tissue stiffness between the study groups.\n\nIt is hypothesized that SE will be able to detect differences in paraurethral tissue elasticity, with SUI being associated with increased tissue compliance. The study also aims to determine whether SE can reliably distinguish between varying degrees of tissue stiffness in women with SUI and continent controls.\n\nPathophysiological focus:\n\nThe study will explore key mechanisms underlying SUI, including:\n\n* Weakened bladder neck support\n* Impaired urethral stabilization due to increased tissue elasticity and collagen degradation\n* While conventional 2D ultrasound provides anatomical information, it does not directly evaluate tissue biomechanics. In contrast, SE enables real-time visualization of tissue elasticity, offering a promising adjunct to traditional urogynecological assessment methods.\n\nStandardization and Protocol\n\nThe study will follow a standardized protocol to ensure reproducibility and high-quality data. Key methodological elements include:\n\n* Minimal probe compression during introital ultrasound to avoid artifacts\n* Bladder emptying prior to examination to eliminate confounding effects\n* Carefully standardized ROI placement across all patients\n* Controlled image acquisition conditions to reduce variability\n\nFuture Directions\n\n* Future research based on this study will aim to:\n* Optimize SE protocols and refine ROI placement strategies\n* Establish clinical cutoff values for differentiating tissue stiffness in SUI vs. continent women\n* Assess the long-term effects of pelvic floor muscle training (PFMT) and vaginal estrogen therapy on paraurethral biomechanics\n* Facilitate the integration of SE into routine urogynecological practice to support early diagnosis and personalized treatment strategies for SUI",[548,549,550,551,552,28],"Urinary Incontinence","Urinary Incontinence, Stress","Urinary Incontinence (UI)","Urinary Bladder, Overactive","Incontinence, Overactive Bladder, Stress Urinary Incontinence",[548,554,555,556],"Bladder dysfunction","Urine leakage","Stress urinary incontinence (SUI)","2025-04-15",{"date":39,"type":37},{"date":560,"type":37},"2024-08-16",{"date":562,"type":21},"2030-01-01",{"name":564,"class":85},"Szeged University",{"id":566,"slug":567,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":571,"eligibilityCriteria":572,"healthyVolunteers":11,"sex":52,"minAge":53,"maxAge":4,"enrollmentInfo":573,"targetDuration":575,"studyType":98,"phases":4,"briefSummary":576,"conditions":577,"keywords":578,"overallStatus":75,"whyStopped":4,"lastUpdateSubmitDate":582,"lastUpdatePostDateStruct":583,"startDateStruct":585,"completionDateStruct":587,"leadSponsor":589,"locationsCount":4},"100567246","long-term-evaluation-of-the-i-stop-sling-in-stress-urinary-incontinence-treatment-100567246","NCT06665698","Long-term Evaluation of the I-STOP Sling in Stress Urinary Incontinence Treatment","Prospective Study to the Evaluate the Long-term Use of Synthetic I-STOP® Device for Treatment of Stress Urinary Incontinence in Women","VIGI-ISTOP","Inclusion Criteria:\n\n* Adult woman aged over 18 ;\n* Patient with SUI, having escaped \"conservative\" medical treatment, with indication for surgical treatment with implantation of an I-STOP® strip via trans-obturator or retropubic route as indicated in the instructions for use of the SUI implant ;\n* Patient affiliated to a social security scheme;\n* Patient capable of completing a self-questionnaire;\n* Patient able to understand the protocol and follow the visit schedule;\n* Patient having signed informed consent.\n\nExclusion Criteria:\n\n* Minor patient, pregnant or breastfeeding ;\n* Adult patient subject to a measure of legal protection, guardianship, curatorship or deprived of liberty by judicial or administrative decision ;\n* Patient presenting a contraindication to the use of the implant indicated in the instructions for use of the implant ;\n* Patient with a medical contraindication to surgery and\u002For anaesthesia.",{"count":574,"type":21},500,"10 Years","Evaluate quality of life and rate of reoperation after implantation of the I-STOP sling for stress urinary incontinence",[28],[579,580,581],"I-STOP","MUS","Sling","2024-10-28",{"date":584,"type":37},"2024-10-30",{"date":586,"type":21},"2024-11",{"date":588,"type":21},"2034-12",{"name":590,"class":44},"DILO Medical"]