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โ† Trials
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Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence

RecruitingNAAges 21 Years - anyFemaleNICHD Pelvic Floor Disorders Network
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In plain words

What the trial is, and whether it could suit you

This is a multicentered, double-blind, randomized controlled, surgical trial of 358 women with inadequate symptom relief of stress urinary incontinence (SUI) or stress predominant mixed urinary incontinence (MUI) after conservative care. The Primary Aim is to determine the comparative effectiveness (as defined by "much" or "very much" better on PGI-I) of transurethral bulking agent (TBA) \[for 1 or 2 injections in 12 months\] vs. single-incision sling (SIS) 12 months after treatment intervention in women with predominant stress urinary incontinence (SUI).

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women โ‰ฅ 21 years * For \> 3 months, bothersome SUI (response of somewhat, moderately, or quite a bit) without UUI or stress-predominant MUI. For those with equal bother of UUI and SUI, clinician determination that SUI is more severe/significant than UUI is required. * A positive cough stress test on standardized non-invasive testing or urodynamic SUI within the past 18 months. * Normal PVR \< 150 mL * Candidate for either study procedure as determined by treating surgeon * Available for up to 3 years. * Agrees to randomization. Exclusion Criteria: * Anterior/apical vaginal prolapse beyond the hymen (\>0 on POPQ) * Urge-predominant mixed UI despite stable therapy * Advanced UUI/OAB 3rd line therapy treatment within 1 year of enrollment. * Planned hysterectomy, urethral or anterior/apical surgeries s requiring general anesthesia at the time of SUI treatment, during the last 6 months, or planned within the next 12 months. * Malignancy or history of radiation of the pelvis * Pregnant, post-partum, breast feeding or plans for pregnancy within 1 year * Incomplete emptying (PVR \> 150mL) * Prior anti-incontinence procedure * Neurogenic bladder * Unwilling to continue current UUI treatment until completion of primary outcome at 12 months * Prior adverse reaction to synthetic mesh or urethral bulking material * Chronic bladder or pelvic pain conditions (e.g., Interstitial cystitis, painful bladder syndrome, fibromyalgia, chronic pelvic pain, etc.) * Active treatment for SUI with a pessary. For those using a pessary or other SUI support device, a 3-week washout period should occur prior to assessing baseline measures.
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What it tests

  • Solyx Single-incision Sling
  • Bulkamid Transurethral Bulking Agent
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Where

7 sites
University of California at San Diego
La Jolla, United States
Kaiser Permanente -- San Diego
San Diego, United States
University of Chicago
Chicago, United States
Duke University, Duke Division of Urogynecology and Reconstructive Pelvic Surgery
Durham, United States
University of Pennsylvania
Philadelphia, United States
Brown/ Women and Infants Hospital of Rhode Island, Division of Urogynecology and Reconstructive Pelvic Surgery
Providence, United States
University of Texas Southwestern Medical Center
Dallas, United States
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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