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 type | Observational |
|---|---|
| Ages | 18 Years to 99 Years |
| Sex | Women only |
| Enrollment | 159 (estimated) |
| Sponsor | Walter Reed National Military Medical Center Federal |
| Locations | 1 site (Bethesda, Maryland) |
| Status | Recruiting |
| Started | November 1, 2024 |
| Main results expected | June 30, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | December 11, 2024 |
| Trial ID | NCT06729151 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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PRP injection for female sexual function
This trial tests whether a patient’s own PRP injection into the front vaginal wall can improve sexual function in women with sexual dysfunction.
-
Aerobic Exercise and Massage for Painful Bladder Syndrome in Women
This study tests whether adding aerobic exercise and connective tissue massage to patient education helps reduce bladder pain and improve symptoms for women with bladder pain syndrome.
-
Does the anesthetic method during endometrial sampling affect sexual function a month later?
This study tests whether sedo-analgesia or local anesthesia during endometrial sampling influences female sexual function one month after the procedure.
-
Neovasculgen for interstitial cystitis with Hunner's lesions
This study will test whether Neovasculgen can reduce bladder scarring and prevent bladder shrinkage in women with interstitial cystitis and Hunner's lesions.
-
At-home dorsal genital nerve stimulation for female sexual dysfunction
This pilot will test whether regular at-home dorsal genital nerve stimulation or use of a smart vibrator can help premenopausal and postmenopausal women with female sexual dysfunction improve arousal symptoms.
-
Evaluating a catheter-free method for bladder medication delivery
This study is testing a new way to deliver bladder medication without a catheter to see if it’s more comfortable and safer for people with conditions like interstitial cystitis and recurrent urinary tract infections.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.