Actively Recruiting
Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome
Led by Walter Reed National Military Medical Center · Updated on 2024-12-11
159
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research is focused on women aged 18 years and older diagnosed with interstitial cystitis/bladder pain syndrome (IC/BPS), a condition that causes bladder-related pain and urinary symptoms lasting more than six weeks without infection or other causes. The study aims to assess how sexual function changes after treatment with either intradetrusor onabotulinumtoxinA injection or conservative management, compared to healthy controls without IC/BPS. Sexual dysfunction is common in women with IC/BPS, often linked to pain during intercourse, and this study seeks to fill a gap in understanding treatment effects on sexual health. Participants are divided into three groups: healthy controls who complete questionnaires once, IC/BPS patients who choose conservative management involving dietary and behavioral changes, and IC/BPS patients who opt for bladder Botox injections. Both treatment groups complete questionnaires before treatment and again 12 weeks afterward to measure changes. The Botox is given through cystoscopic injection following standard clinical procedures, while the conservative group follows recommended non-drug therapies. During the study, participants complete various assessments including the Female Sexual Function Index, O'Leary Sant index, patient impressions of improvement and severity, and pain and bladder symptom scales. Researchers also monitor adverse events like urinary tract infections and urinary retention for 12 weeks after treatment starts. The study will track the changes in sexual function and other symptoms over this period, with healthy controls providing baseline comparisons. Recruitment aims for about 55 participants per group to allow for some dropouts and ensure reliable results.
CONDITIONS
Brief Title
Effect of Intradetrusor onabotulinumtoxinA Injection Versus Conservative Management on Female Sexual Function in Patients With Bladder Pain Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants complete questionnaires before treatment and again 12 weeks after treatment or conservative management to assess symptoms and sexual function.
2 visits (pre-treatment and 12 weeks post-treatment)
Trial Site Locations
Total: 1 location
1
Walter Reed National Military Medical Center
Bethesda, Maryland, United States, 20816
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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