Transvaginal botulinum toxin A (BTA) injection for Bladder Pain Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Urology Clinic (Stanford University), 1000 Welch Road, Suite 100, Palo Alto, CA
Bladder Pain Syndrome+5 More
Transvaginal botulinum toxin A (BTA) injection - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Bladder Pain Syndrome
  • Interstitial Cystitis

Treatment Effectiveness

Study Objectives

1 Primary · 4 Secondary · Reporting Duration: Baseline through week 12

Baseline through week 12
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)]
Change from baseline in Patient Global Impression of Change (PGIC) scale
Change from baseline in Short Form 12-item Survey (SF12)

Trial Safety

Trial Design

1 Treatment Group

Transvaginal Botulinum Toxin A (BTA) injection
1 of 1
Experimental Treatment

12 Total Participants · 1 Treatment Group

Primary Treatment: Transvaginal botulinum toxin A (BTA) injection · No Placebo Group · Phase < 1

Transvaginal Botulinum Toxin A (BTA) injection
Drug
Experimental Group · 1 Intervention: Transvaginal botulinum toxin A (BTA) injection · Intervention Types: Drug
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

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline through week 12
Closest Location: Urology Clinic (Stanford University), 1000 Welch Road, Suite 100 · Palo Alto, CA
Photo of california 1Photo of california 2Photo of california 3
2021First Recorded Clinical Trial
1 TrialsResearching Bladder Pain Syndrome
1 CompletedClinical Trials

Who is running the clinical trial?

McCormick and Gabilan Faculty Fellowship AwardUNKNOWN
Stanford UniversityLead Sponsor
2,130 Previous Clinical Trials
35,668,898 Total Patients Enrolled
1 Trials studying Bladder Pain Syndrome
40 Patients Enrolled for Bladder Pain Syndrome
Amy D. Dobberfuhl, M.D.Principal InvestigatorStanford University
1 Previous Clinical Trials
15 Total Patients Enrolled

Eligibility Criteria

Age 18+ · Female Participants · 2 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
The patient is female and is considering BTA chemodenervation for the treatment of refractory IC/BPS.
You are female and have IC/BPS.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.