Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

Recruiting

Trial ID: NCT05485207

Purpose

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.

Official Title

T3STOPBPS: Open Label Clinical Trial of Transvaginal Trigone Treatment (T3) With Botulinum Toxin A (BTA) for Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS)

Stanford Investigator(s)

Amy D. Dobberfuhl, MD, MS
Amy D. Dobberfuhl, MD, MS

Assistant Professor of Urology

Eligibility


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

Intervention(s):

drug: Transvaginal botulinum toxin A (BTA) injection

Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Amy D. Dobberfuhl, M.D.
650-723-3391