drugset / Trial / NCT05485207

Transvaginal Botulinum Toxin A for Interstitial Cystitis / Bladder Pain Syndrome

NCT05485207

NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2022-04-04
Primary completion
2025-02-28
Completion
2025-02-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 50 iu Other
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu Other

Indications