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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
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