Botulinum Toxin A for Bladder Pain Syndrome
(T3STOPBPS Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Interstitial cystitis / bladder pain syndrome (IC/BPS) is a debilitating condition that affects millions of women in the United States. Women suffer from recurring pelvic pain, bladder pressure, painful bladder, urinary frequency (needing to go often) and urgency (feeling a strong need to go). Women are five times more likely to suffer from IC/BPS than men. IC/BPS is a common cause of painful bladder after excluding urinary tract infection. About one-third of women resort to opioids, thus contributing to the current opioid crisis. Sadly, there are no durable treatments and the majority of therapies are not FDA-approved for IC/BPS.
Who Is on the Research Team?
Amy D. Dobberfuhl, M.D.
Principal Investigator
Stanford University
Are You a Good Fit for This Trial?
This trial is for women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who are considering botulinum toxin A injections due to lack of relief from other treatments. Women who can't have transvaginal procedures, are pregnant or breastfeeding, participating in conflicting studies, or allergic to BTA or lidocaine cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a 50 unit T3 BTA injection at baseline, with follow-up assessments at 6 and 12 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment, with potential dose escalation to 100 units if needed
Open-label extension (optional)
Participants may receive repeat BTA injection if less than 50% improvement in symptoms is reported
What Are the Treatments Tested in This Trial?
Interventions
- Transvaginal Botulinum Toxin A
Find a Clinic Near You
Who Is Running the Clinical Trial?
Stanford University
Lead Sponsor
McCormick and Gabilan Faculty Fellowship Award
Collaborator