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NCT06729151 · ClinicalTrials.gov registry record

Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome

A clinical trial of Bladder Pain Syndrome and Female Sexual Dysfunction, sponsored by Walter Reed National Military Medical Center.

Recruiting
Registry status
159
Enrollment target
1
Study location

NCT06729151: Recruiting study of Bladder Pain Syndrome and Female Sexual Dysfunction, sponsored by Walter Reed National Military Medical Center.

NCT06729151 is a study of Bladder Pain Syndrome and Female Sexual Dysfunction that is actively recruiting participants, run by Walter Reed National Military Medical Center. The registered enrollment target is 159 participants, roughly in line with the 158-participant average among 13 other Bladder Pain Syndrome trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06729151, a study of Bladder Pain Syndrome and Female Sexual Dysfunction, is actively recruiting participants, sponsored by Walter Reed National Military Medical Center.

RECRUITING
Registry status
159 participants
Enrollment target
1
Study location

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

Primary Outcome

19-question survey encompassing several domains of sexual function in females

Conditions Studied

Bladder Pain Syndrome Female Sexual Dysfunction

Interventions

  • DRUG Onabotulinum toxin A
  • BEHAVIORAL Conservative management (dietary and behavioral)

Study Locations (1)

Maryland

  • Walter Reed National Military Medical Center - Bethesda

Trial Details

FieldValue
Enrollment Target 159 participants
Start Date 2024-11-01
Est. Completion 2026-12-31
Walter Reed National Military Medical Center

48 total trials

What NCT06729151 shows while recruiting

NCT06729151 is an observational study that tracks outcomes without assigning an intervention. The registered 159 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 158-participant average among 13 other Bladder Pain Syndrome trials with a reported enrollment target.

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.

NCT06729151 reports a single indexed study location in Maryland.

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.

What interventions are being tested in trial NCT06729151?

The interventions under investigation include: Onabotulinum toxin A (DRUG), Conservative management (dietary and behavioral) (BEHAVIORAL).

Who is sponsoring clinical trial NCT06729151?

This trial is sponsored by Walter Reed National Military Medical Center, which has 48 total clinical trials registered on ClinicalTrials.gov.

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.

Learn More About Clinical Trials

Similar trials for Bladder Pain Syndrome

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06729151's enrollment target sits among peer trials

159 4th of 13 higher than 10 of 13 other Bladder Pain Syndrome trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Bladder Pain Syndrome trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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More recruiting context for NCT06729151

Source: ClinicalTrials.gov NCT06729151, the US trial registry maintained by the National Library of Medicine. NCT06729151 (mid enrollment · single site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.