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).
Women ≥ 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
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.
Parallel
Solyx Single-incision Sling
DeviceMinimally invasive mesh device placed to treat stress urinary incontinence.
Bulkamid Transurethral Bulking Agent
DeviceMinimally invasive bulking agent injections used to bulk up the tissue surrounding the urethra to treat stress urinary incontinence. Up to 2 treatments within 12 months are allowed
Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months.
The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence.
Rates of retreatment
Rates of additional, non-protocol treatments (including other medications, therapies, or medical procedures) for stress urinary incontinence within 12 months after the initial TBA vs. SIS including success rates after 1 vs 2 TBA injections.
Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score
The International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) consists of 3 scorable questions measuring frequency of leakage, volume of leakage, and associated bother with leakage, for a range of scores from 0 (no leakage or bother) to 21 (worst leakage, most bothersome). A fourth question asks which type(s) of leakage are occurring. The ICIQ-SF score is collected at baseline and each follow-up time point up to 36 months according to treatment assignment and as treated.
Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS
The PGI-I is used to compare condition improvement, defined as (1) = very much better, (2) = much better, (3) = a little better, (4) = no change, (5) = a little worse, (6) much worse, (7) very much worse. Determine the comparative effectiveness (as defined by "much" or "very much" improved on PGI-I) of transurethral bulking agent \[for 1 or 2 injections in 12 months\] vs. single-incision sling 12 months after treatment intervention in women with predominant stress urinary incontinence. PGI-I at each follow up time point up to 36 months according to treatment assignment and as treated.
Condition improvement measured by Patient Global Symptom Control [PGSC] for TBA vs. SIS
The Patient Global Symptom Control (PGSC) is a patient-reported measure of perceived agreement that symptoms are under control, as assessed on a scale of 1 (Disagree Strongly) to 5 (Agree Strongly). Included here are participants who had reported disagreements as indicated by a rating of 1 (Disagree Strongly) or 2 (Disagree) PGSC is collected at baseline and each follow up time point up to 36 months according to treatment assignment and as treated.
Click on the lead sponsor to view all of their trials.
NICHD Pelvic Floor Disorders Network
Lead sponsor
Duke University
Collaborator
Kaiser Permanente
Collaborator
University of Chicago
Collaborator
University of Pennsylvania
Collaborator
University of Texas Southwestern Medical Center
Collaborator
Women and Infants Hospital of Rhode Island
Collaborator
RTI International
Collaborator
University of California, San Diego
Collaborator
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Collaborator
