Comparing Botox injections to conservative management for female sexual function in bladder pain syndrome
Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome
Walter Reed National Military Medical Center · NCT06729151
This study tests whether Botox injections can improve sexual function in women with bladder pain syndrome better than standard treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 159 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | Walter Reed National Military Medical Center (fed) |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT06729151 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with contraindications for bladder Botox, neurogenic bladder, or other urinary tract diseases may not benefit from this study.
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 performed: 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.
Eligibility criteria
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 this trial is running
Bethesda, Maryland
- Walter Reed National Military Medical Center — Bethesda, Maryland, United States (RECRUITING)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Bladder Pain Syndrome, Female Sexual Dysfunction