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Neurotoxin

Botulinum Toxin A for Bladder Pain Syndrome (T3STOPBPS Trial)

Phase < 1

Waitlist Available

Led By Amy D. Dobberfuhl, M.D.

Research Sponsored by Stanford University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Females with IC/BPS

Be older than 18 years old

Must not have

Patients who are unable to undergo a transvaginal intervention as a result of anatomic barriers or discomfort will be excluded from enrollment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 12

Awards & highlights

No Placebo-Only Group

Summary

This trial is for a new potential treatment for IC/BPS.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include discomfort at the injection site, possible allergic reactions, and typical risks associated with botulinum toxins like muscle weakness or trouble breathing if spread occurs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline through week 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline through week 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through week 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Change from baseline in American Urological Association Symptom Score (AUASS)

Change from baseline in International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms (ICIQ FLUTS)

Change from baseline in O'Leary Sant (OLS) Symptom Score [Interstitial Cystitis Symptom Index (ICSI) / Interstitial Cystitis Problem Index (ICPI)]

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Transvaginal botulinum toxin A (BTA) injection

2019

Completed Early Phase 1

~20

0 / 2Eligibility criteria met