[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Uromedica\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":71},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":28,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100381567","adjustable-continence-therapy-act-for-the-treatment-of-female-sui-100381567",false,"NCT04248283","Adjustable Continence Therapy (ACT) for the Treatment of Female SUI","A Clinical Investigation of the Adjustable Continence Therapy (ACT) for Female Stress Urinary Incontinence Due to Intrinsic Sphincter Deficiency","Inclusion Criteria:\n\n1. Female at least 22 years old\n2. Diagnosed with stress urinary incontinence with primary Intrinsic Sphincter Deficiency\n3. Provocative pad weight of greater than 11.0 grams\n4. Candidate for surgical intervention\n5. Negative urinalysis\n6. Normal cystourethroscopy\n7. Failed at least 6 months of previous treatment(s) for stress urinary incontinence (e.g., exercise regimen, electrical stimulation, surgical procedures, etc). Note: patients may have failed prior anti-incontinence procedures for SUI (e.g., suspension, sling, or urethral bulking agent)\n8. Willing and able to sign informed consent and comply with trial follow-up requirements\n\nExclusion Criteria:\n\n1. Pregnant or lactating\n2. Life expectancy of less than 5 years\n3. Has uncontrolled diabetes as evidenced by HbA1c over 6.5% and fasting plasma glucose over 130 mg\u002FdL\n4. Has auto-immune disease\n5. Undergoing radiation therapy\n6. Active urinary tract infection\n7. Detrusor instability refractory to medication\n8. Reduced bladder compliance as defined by a cystometrogram\n9. Significant residual volume (greater than 100 ml) after voiding in which detrusor contraction is weak, when the bladder volume is greater than or equal to 250 ml\n10. Has, had, or is suspected of having bladder cancer\n11. History of bladder stones\n12. Urethral stricture evidenced during cystourethroscopy\n13. Has a neurogenic bladder that is atonic or has detrusor sphincter dyssynergia\n14. Has a diathesis, hemophilia, or a bleeding disorder\n15. Has a rectocele, cystocele, urethrocele, enterocele, or pelvic prolapse of grade 3 or higher\n16. Had prior pelvic radiotherapy\n17. Had a prior artificial urinary sphincter implanted\n18. Has a neurogenic condition known to affect bladder\u002Fsphincter function","FEMALE","22 Years",{"count":19,"type":20},167,"ESTIMATED","INTERVENTIONAL",[23],"NA","A prospective, single arm, non-randomized, multicenter, prospective case-series trial. The purpose of this trial is to demonstrate the safety and effectiveness of using the Adjustable Continence Therapy (ACT) to provide a clinically relevant improvement in stress urinary incontinence.",[26,27],"Urinary Incontinence","Urinary Incontinence,Stress",[26,29,30,31,32],"Urination Disorders","Urination Involuntary","Urologic Diseases","Lower Urinary Tract Symptoms","RECRUITING","2026-06-15",{"date":36,"type":37},"2026-06-17","ACTUAL",{"date":39,"type":37},"2021-01-26",{"date":41,"type":20},"2032-05-31",{"name":43,"class":44},"Uromedica","INDUSTRY",5,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":53,"sex":54,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":21,"phases":58,"briefSummary":59,"conditions":60,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100344663","proact-post-approval-study-100344663","NCT03767595","ProACT Post-Approval Study","Post Approval Study of the ProACT™ Adjustable Continence Therapy for Men","Inclusion Criteria:\n\n1. Subject is a male of at least 50 years of age.\n2. Subject demonstrates stress urinary incontinence.\n3. Subject has undergone a radical prostatectomy, transurethral resection of the prostate, or other prostate surgery.\n4. Subject is willing and able to undergo surgical implantation of ProACT devices.\n5. Subject is willing and able to comply with study-required\n\n   follow-up activities, including annual telephonic follow -up interviews, for a period of 5 years from their date of initial implantation. This includes compliance even after possible explant of ProACT devices and\u002For possible implantation of subsequent therapies.\n6. Subject is willing and able to sign the approved informed consent.\n7. Subject has two positive 24-hour pad weight tests (greater than or equal to 8 gram pad weight increase demonstrated in two 24-hour pad weight tests).\n8. Subject has a negative urine culture.\n9. Subject has no known urogenital malignancy, other than previously treated prostate cancer.\n10. Subject meets ONE of the following criteria:\n\n    1. Baseline Prostate-Specific Antigen (PSA) of less than or equal to 2.5ng\u002FmL;\n    2. Baseline PSA \\> 2.5ng\u002FmL and less than or equal to 10 ng\u002FmL AND free PSA greater than or equal to 25% of total PSA;\n11. Physician determines subject to be a suitable surgical candidate.\n\nExclusion Criteria:\n\n1. Subject has an existing urethral stricture, a history of any urethral strictures, or has ever had a urethrotomy.\n2. Subject has undergone prostate surgery or any anti-incontinence surgery within the last 12 months.\n3. Subject has an artificial urinary sphincter or any components of a previously implanted artificial urinary sphincter in vivo.\n4. Subject has undergone radiation therapy in the prostatic area within the last 12 months.\n5. Subject has untreated or unsuccessfully treated detrusor instability or over-activity.\n6. Subject has an atonic bladder.\n7. Subject had, presently has, or is suspected of having bladder cancer.\n8. Subject has untreated or unsuccessfully treated bladder stones.\n9. Subject has detrusor sphincter dyssynergia.\n10. Subject has known hemophilia or a bleeding disorder.\n11. Subject has a known severe contrast solution allergy (e.g., anaphylaxis, cardiac, or respiratory arrest).\n12. Subject has insulin-dependent diabetes that is uncontrolled or not controllable, as indicated by an A1c test result of = 6.5%.",true,"MALE","50 Years",{"count":57,"type":20},145,[23],"The ProACT Post Approval Study is a 5-year prospective, open-label, multi-center study designed to evaluate the long-term incidence of urethral stricture and device erosion after ProACT implantation. In addition, the study will evaluate whether treatment with ProACT affects clinical outcomes after subsequent SUI therapies.",[61],"Stress Urinary Incontinence","2024-11-25",{"date":64,"type":37},"2024-11-29",{"date":66,"type":37},"2019-02-19",{"date":68,"type":20},"2030-09-01",{"name":43,"class":44},6,""]