Botulinum Toxin A for Bladder Pain Syndrome
(T3STOPBPS Trial)

Recruiting in Palo Alto (17 mi)

Overseen byAmy D. Dobberfuhl, M.D.

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: Stanford University

No Placebo Group

Trial Summary

What is the purpose of this trial?

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.

Research Team

Amy D. Dobberfuhl, M.D.

Principal Investigator

Stanford University

Eligibility Criteria

This trial is for women with Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS) who are considering botulinum toxin A injections due to lack of relief from other treatments. Women who can't have transvaginal procedures, are pregnant or breastfeeding, participating in conflicting studies, or allergic to BTA or lidocaine cannot join.

Inclusion Criteria

I am considering BTA treatment for my severe bladder pain syndrome.

I am a woman with interstitial cystitis/bladder pain syndrome.

Exclusion Criteria

You are currently participating in another study that has similar goals or symptoms.

You are allergic to BTA injection therapy or lidocaine.

I am able to undergo transvaginal procedures without anatomical issues or discomfort.

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Treatment Details

Interventions

Transvaginal Botulinum Toxin A (Neurotoxin)

Trial OverviewThe study tests the effectiveness of transvaginal botulinum toxin A injections in alleviating symptoms of IC/BPS such as pelvic pain and frequent urge to urinate. The goal is to find a durable treatment option beyond current therapies.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Transvaginal Botulinum Toxin A (BTA) injectionExperimental Treatment1 Intervention

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.