NCT06480227 · NICHD Pelvic Floor Disorders Network
Trial of Transurethral Bulking Agent Injection Versus Single-Incision Sling for Stress Urinary Incontinence
(BASIS)
What this study is about
This is a multicentered, where neither patients nor doctors know which treatment is given, randomly assigned 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.
View original scientific description
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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.
Where
- La Jolla, California
- San Diego, California
- Chicago, Illinois
- Durham, North Carolina
- Philadelphia, Pennsylvania
- Providence, Rhode Island
- Dallas, Texas
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jun 8, 2026 · Source of record for eligibility and locations