Clinical trial Recruiting at 1 site Observational Ages 18 to 99 Women only

Comparing Botox injections to conservative management for female sexual function in bladder pain syndrome

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

Run by Walter Reed National Military Medical Center · NCT06729151 · Data updated 2026-11-12

This study tests whether Botox injections can improve sexual function in women with bladder pain syndrome better than standard treatment options.

Quick facts

Study typeObservational
Ages18 Years to 99 Years
SexWomen only
Enrollment159 (estimated)
SponsorWalter Reed National Military Medical Center
Federal
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedNovember 1, 2024
Main results expectedJune 30, 2026
Study endsDecember 31, 2026
Registry record updatedDecember 11, 2024
Trial IDNCT06729151 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are women aged 18 and older with a diagnosis of bladder pain syndrome and an O'Leary Sant score of 13 or greater.

Probably not a fit

Patients with contraindications for bladder Botox, neurogenic bladder, or other urinary tract diseases may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study investigates the effects of intradetrusor onabotulinumtoxinA injections compared to conservative management on female sexual function in patients diagnosed with bladder pain syndrome. The study focuses on women aged 18 and older who experience significant bladder pain and associated sexual dysfunction. Participants will be evaluated based on their O'Leary Sant scores to determine eligibility, and the study aims to assess the impact of these interventions on quality of life and sexual health. The research is conducted at the Walter Reed National Military Medical Center.

Why it matters

Potential benefit: If successful, this study could improve sexual function and overall quality of life for women suffering from bladder pain syndrome.

How similar studies have gone: Previous studies have shown significant sexual dysfunction in women with bladder pain syndrome, indicating that this approach may yield beneficial insights, although the specific comparison of Botox to conservative management is less commonly explored.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* Female 18 years of age and older
* For bladder pain syndrome participants: O'Leary Sant score 13 or greater
* For healthy controls: O'Leary Sant score 12 or less
* DEERS eligible (care provided by military health care system)

Exclusion Criteria:

* Contraindications for bladder Botox
* Current use of alternative treatment for bladder pain syndrome
* Neurogenic bladder
* Other urinary tract disease
* Pelvic organ prolapse stage 3 or greater
* Pregnancy or breastfeeding
* Non-English speakers

Where it's running

  • Walter Reed National Military Medical Center
    Bethesda, Maryland, United States
    Recruiting

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.