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ACTIVE NOT RECRUITING
NCT05485207
EARLY_PHASE1

Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

Sponsor: Stanford University

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

5

Start Date

2022-04-04

Completion Date

2025-02-28

Last Updated

2024-04-19

Healthy Volunteers

No

Interventions

DRUG

Transvaginal botulinum toxin A (BTA) injection

Botulinum toxin A (Botox® 100 units) will be injected into the detrusor muscle of the bladder by inserting a needle through the anterior vaginal wall.

Locations (1)

Urology Clinic (Stanford University), 1000 Welch Road, Suite 100

Palo Alto, California, United States