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Bulking Agent
Solyx Single-incision Sling for Urinary Incontinence (BASIS Trial)
N/A
Waitlist Available
Led By Marie Gantz, MD
Research Sponsored by NICHD Pelvic Floor Disorders Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
* Women \>21 years
* Bothersome SUI (PFDI-20 Q:#17 of somewhat, moderately or quite a bit) or stress predominant MUI (PFDI-20 Q:#16 \< Q:#17)50 for \> 3 months with well-controlled UUI on stable medication treatment through baseline and follow-up.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 3 to 12 months post-intervention.
Awards & highlights
Summary
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" improved 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).
Who is the study for?
This trial is for women who have stress urinary incontinence (SUI) or mixed urinary incontinence with a stress component, and haven't found relief from conservative treatments. Specific eligibility criteria are not provided, but typically participants must meet certain health standards and agree to follow the study procedures.
What is being tested?
The trial is testing two different treatments for SUI: Bulkamid Transurethral Bulking Agent injections versus the Solyx Single-incision Sling procedure. It's designed to see which one is more effective at improving symptoms after 12 months.
What are the potential side effects?
Potential side effects are not detailed here, but generally, bulking agents can cause temporary discomfort or urinary issues, while slings may lead to pain at the incision site, problems urinating, or infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from 3 months to 36 months post-intervention.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 3 months to 36 months post-intervention.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Subjective success measured by Patient Global Impression-Improvement [PGI-I] (>2) for TBA vs. SIS at 12 months.
Secondary study objectives
Blood Loss
Change in Incontinence Questionnaire-Urinary Incontinence Short Form [ICIQ-SF] score
Condition improvement measured by Patient Global Impression of Severity [PGI-S] for TBA vs. SIS
+18 moreTrial Design
2Treatment groups
Active Control
Group I: Solyx Single-incision SlingActive Control1 Intervention
Solyx Single-incision Sling
Group II: Bulkamid Transurethral Bulking AgentActive Control1 Intervention
Bulkamid Transurethral Bulking Agent
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Who is running the clinical trial?
Kaiser PermanenteOTHER
551 Previous Clinical Trials
27,689,868 Total Patients Enrolled
10 Trials studying Urinary Incontinence
4,067 Patients Enrolled for Urinary Incontinence
RTI InternationalOTHER
195 Previous Clinical Trials
816,921 Total Patients Enrolled
4 Trials studying Urinary Incontinence
1,232 Patients Enrolled for Urinary Incontinence
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
2,009 Previous Clinical Trials
2,696,701 Total Patients Enrolled
13 Trials studying Urinary Incontinence
3,004 Patients Enrolled for Urinary Incontinence
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