Botulinum Toxin A for Bladder Pain Syndrome

(T3STOPBPS Trial)

Overseen By Amy D. Dobberfuhl, M.D.

Age: 18+

Sex: Female

Trial Phase: Phase < 1

Sponsor: Stanford University

Disqualifiers: Pregnancy, Breastfeeding, Others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

5 Participants Needed

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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 50 unit T3 BTA injection at baseline, with follow-up assessments at 6 and 12 weeks

12 weeks

3 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with potential dose escalation to 100 units if needed

12 weeks

1 visit (in-person)

Open-label extension (optional)

Participants may receive repeat BTA injection if less than 50% improvement in symptoms is reported

3 to 12 months

Treatment Details

Interventions

• Transvaginal Botulinum Toxin A

Trial Overview The 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

Group I: Transvaginal Botulinum Toxin A (BTA) injection Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Stanford University

Lead Sponsor

Trials

2,527

Recruited

17,430,000+

McCormick and Gabilan Faculty Fellowship Award

Collaborator

Trials

1

Recruited

5+