← Back to Search

Bulking Agent

Bulking Agent vs Sling for Stress 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

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

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 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.

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

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

0 / 8Eligibility criteria met

Find a Location

Who is running the clinical trial?

Kaiser PermanenteOTHER

551 Previous Clinical Trials

27,690,602 Total Patients Enrolled

10 Trials studying Urinary Incontinence

4,067 Patients Enrolled for Urinary Incontinence

RTI InternationalOTHER

195 Previous Clinical Trials

816,825 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

2,014 Previous Clinical Trials

2,696,476 Total Patients Enrolled

13 Trials studying Urinary Incontinence

3,004 Patients Enrolled for Urinary Incontinence

~239 spots leftby Jun 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.