UnknownEarly Phase 1

Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

United States5 participantsStarted 2022-04-04

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Change from baseline in Patient Global Impression of Change (PGIC) scale

Timeframe: Baseline through week 12

Trial details

NCT IDNCT05485207

SponsorStanford University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

View on ClinicalTrials.gov More Interstitial Cystitis trials