Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

• Status: Recruiting
• Trial end date: 2024-09-01
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Collaborator: McCormick and Gabilan Faculty Fellowship Award
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A

Criteria

Inclusion Criteria:

• Females with IC/BPS

• Females who are considering intradetrusor BTA chemodenervation for the treatment of refractory IC/BPS

Exclusion Criteria:

• Involvement in other studies with potentially overlapping indications or symptoms

• Patients who are unable to undergo a transvaginal intervention as a result of anatomic barriers or discomfort will be excluded from enrollment

• patients known to be pregnant or breastfeeding

• Known allergy to BTA injection therapy or lidocaine