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Neurotoxin

Botulinum Toxin A for Bladder Pain Syndrome (T3STOPBPS Trial)

Q: What is the current size of enrollment for this medical investigation?

<p>Affirmative. Per the info available on clinicaltrials.gov, recruitment is ongoing for this particular trial which was initially posted in April of 2022 and last updated in August of that year. A total of 12 volunteers will be enrolled from a single location.</p>

Q: Is there still availability for individuals to partake in this experiment?

<p>Affirmative. The facts on clinicaltrials.gov indicate that this research is actively recruiting volunteers, and it was originally listed on April 4th 2022 with a recent update occurring August 1st 2022. This trial requires 12 individuals to be enrolled from one medical centre.</p>

Phase < 1

Recruiting

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline through week 12

Awards & highlights

T3STOPBPS Trial 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.Check my eligibility

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.See study design

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.

T3STOPBPS Trial 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.

T3STOPBPS Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

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

T3STOPBPS 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

McCormick and Gabilan Faculty Fellowship AwardUNKNOWN

Stanford UniversityLead Sponsor

2,393 Previous Clinical Trials

17,341,180 Total Patients Enrolled

1 Trials studying Interstitial Cystitis

40 Patients Enrolled for Interstitial Cystitis

Amy D. Dobberfuhl, M.D.Principal InvestigatorStanford University

1 Previous Clinical Trials

15 Total Patients Enrolled

Media Library

Transvaginal Botulinum Toxin A (Neurotoxin) Clinical Trial Eligibility Overview. Trial Name: NCT05485207 — Phase < 1

Interstitial Cystitis Research Study Groups: Transvaginal Botulinum Toxin A (BTA) injection

Interstitial Cystitis Clinical Trial 2023: Transvaginal Botulinum Toxin A Highlights & Side Effects. Trial Name: NCT05485207 — Phase < 1

Transvaginal Botulinum Toxin A (Neurotoxin) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05485207 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current size of enrollment for this medical investigation?

"Affirmative. Per the info available on clinicaltrials.gov, recruitment is ongoing for this particular trial which was initially posted in April of 2022 and last updated in August of that year. A total of 12 volunteers will be enrolled from a single location."

Answered by AI

Is there still availability for individuals to partake in this experiment?

"Affirmative. The facts on clinicaltrials.gov indicate that this research is actively recruiting volunteers, and it was originally listed on April 4th 2022 with a recent update occurring August 1st 2022. This trial requires 12 individuals to be enrolled from one medical centre."

Answered by AI