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Bladder Instillations Versus Onabotulinumtoxin A for Treatment of Interstitial Cystitis/Bladder Pain Syndrome
Phase 2
Waitlist Available
Research Sponsored by Walter Reed National Military Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Awards & highlights
No Placebo-Only Group
Summary
This trial compares two treatments for chronic bladder pain: a mixture of heparin and a numbing medicine put directly into the bladder, and Botox injections into the bladder muscle. The goal is to find out which treatment works better for people with interstitial cystitis or bladder pain syndrome, conditions that cause ongoing bladder pain and discomfort. Another treatment being studied is Prolotherapy, which involves injecting solutions like dextrose to reduce pain and promote tissue growth.
Eligible Conditions
- Interstitial Cystitis
- Painful Bladder Syndrome
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 4-6 weeks, 8-10 weeks, 6-9 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Change in 12-item Short Form Survey (SF-12) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Change in Female Sexual Distress Scale-Revised (FSDS-R) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
Change in Female Sexual Function Index (FSFI) score between bladder instillation and intradetrusor onabotulinumtoxinA injection groups
+6 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Active Control
Group I: Heparin & Alkalinized Lidocaine Bladder InstillationActive Control1 Intervention
Six weekly bladder instillations, each instillation consisting of 40,000 IU Heparin, 200mg lidocaine, 2ml 8.4% sodium bicarbonate, sterile water for a total volume 50 milliliters (mL).
Group II: Intradetrusor Onabotulinumtoxin A InjectionActive Control1 Intervention
100 units onabotulinumtoxinA reconstituted in 10mL of injectable saline, injected in 20 sites with 0.5mL per injection along the posterior wall of the bladder above the trigone.
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Who is running the clinical trial?
Walter Reed National Military Medical CenterLead Sponsor
143 Previous Clinical Trials
33,346 Total Patients Enrolled
1 Trials studying Interstitial Cystitis
29 Patients Enrolled for Interstitial Cystitis