← Back to Search

Bulking Agent

Bulking Agent vs Sling for Stress Urinary Incontinence (BASIS Trial)

N/A
Recruiting
Led By Emily Lukacz, 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
Normal voiding function as demonstrated by PVR less than 150 mL
Be older than 18 years old
Must not have
Anterior/apical vaginal prolapse beyond the hymen (greater than 0 on POPQ)
Urge-predominant mixed UI by UDI-6 despite stable therapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from 3 to 12 months post-intervention.
Awards & highlights
No Placebo-Only Group

Summary

"This trial involves 358 women with stress urinary incontinence who did not find relief with conservative treatments. The goal is to compare the effectiveness of two different treatments, transurethral bulking agent

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 below
Select...
I can empty my bladder properly.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
My vaginal prolapse extends beyond the hymen.
Select...
I have strong, sudden urges to urinate despite treatment.
Select...
I am scheduled for surgery on my uterus, urethra, or pelvic area.
Select...
I have had cancer or radiation treatment in my pelvic area.
Select...
I have had surgery to control urinary leakage.
Select...
I have a condition where my bladder doesn't function properly due to nerve damage.
Select...
I am currently using a pessary for stress urinary incontinence.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from 3 months to 36 months post-intervention.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from 3 months to 36 months post-intervention. for reporting.

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 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial 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

Find a Location

Who is running the clinical trial?

Kaiser PermanenteOTHER
552 Previous Clinical Trials
27,731,264 Total Patients Enrolled
10 Trials studying Urinary Incontinence
4,067 Patients Enrolled for Urinary Incontinence
RTI InternationalOTHER
196 Previous Clinical Trials
844,188 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
2,055 Previous Clinical Trials
2,731,528 Total Patients Enrolled
13 Trials studying Urinary Incontinence
3,004 Patients Enrolled for Urinary Incontinence
~239 spots leftby Aug 2027
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top