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Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome
NCT06729151 · View on ClinicalTrials.gov ↗
Study Summary
Interstitial cystitis/bladder pain syndrome (IC/BPS) is estimated to affect 3.3 to 7.9 million women aged 18 years and older in the United States. The American Urological Association (AUA) defines IC/BPS as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary bladder, associated with lower urinary tract symptoms of more than six weeks duration, in the absence of infection or other identifiable causes". IC/BPS significantly impacts quality of life, with the individual domains of sexual function, anxiety and depression, sleep quality and work productivity being specifically affected. Significant sexual dysfunction in women with IC/BPS has been consistently demonstrated across multiple international studies, with a prevalence ranging from 68% to 91%. In fact, among all patients with lower urinary tract symptoms, patients with a diagnosis of IC/BPS had the highest levels of impaired sexual function, mostly due to dyspareunia. Recommended treatments for IC/BPS include dietary and behavioral modifications, oral medications, bladder instillations, bladder hydrodistension, intradetrusor injection of onabotulinumtoxinA and major surgery. Scant research exists on how treating IC/BPS affects sexual function. We are conducting a prospective cohort study to assess for improvement in sexual function following intravesical onabotulinumtoxinA injection versus conservative management for IC/BPS. The study will consist of three groups: intradetrusor onabotulinumtoxinA injection, conservative management and age-matched, healthy controls. All patients aged 18 years and older presenting to the Walter Reed National Military Medical Center (WRNMMC) Urogynecology clinic who are given a diagnosis of IC/BPS and have an O'Leary Sant index questionnaire scoring 13 or greater will be eligible for the study. The primary study outcome is change in the pre- and 12-week post-treatment Female Sexual Function Index (FSFI). The secondary outcomes will include c
Conditions Studied
Interventions
- DRUG Onabotulinum toxin A
- BEHAVIORAL Conservative management (dietary and behavioral)
Study Locations (1)
Maryland
- Walter Reed National Military Medical Center — Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 159 participants |
| Start Date | 2024-11-01 |
| Est. Completion | 2026-12-31 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06729151
The ClinicalTrials.gov registry entry for NCT06729151 describes a study currently listed as recruiting. It is categorized as an unspecified phase, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 159 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Walter Reed National Military Medical Center, which has 73 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Bladder Pain Syndrome appearing as the primary indexed condition, and to 2 interventions — of which Onabotulinum toxin A is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06729151 reports 1 study location spanning 1 distinct geographic area — top geographies include Maryland. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06729151 about?
NCT06729151 is a clinical study titled "Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome". Interstitial cystitis/bladder pain syndrome (IC/BPS) is estimated to affect 3.3 to 7.9 million women aged 18 years and older in the United States. The American Urological Association (AUA) defines IC/BPS as "an unpleasant sensation (pain, pressure, discomfort) perceived to be related to the urinary ...
What is the current status of trial NCT06729151?
This trial is currently recruiting. The enrollment target is 159 participants. The study started on 2024-11-01. Estimated completion is 2026-12-31.
What conditions does trial NCT06729151 study?
This clinical trial studies the following conditions: Bladder Pain Syndrome, Female Sexual Dysfunction. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06729151?
The interventions under investigation include: Onabotulinum toxin A (DRUG), Conservative management (dietary and behavioral) (BEHAVIORAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06729151?
This trial is sponsored by Walter Reed National Military Medical Center, which has 73 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06729151 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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