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Neurotoxin

Transvaginal botulinum toxin A (BTA) injection for Overactive Bladder (FETOC 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention
Awards & highlights

Summary

Overactive bladder (OAB) is a highly prevalent disease process that, when refractory to oral medication therapy, can be effectively managed with injection of botulinum toxin A (BTA) into the detrusor muscle of the bladder. However, the traditional procedure requires a cystoscope inserted into the bladder which can be painful and is associated with a risk of urinary tract infection. The purpose of this study is to determine if transvaginal injection of BTA into the detrusor muscle of the bladder wall is feasible to perform, and efficacious for the treatment of refractory overactive bladder.

Eligible Conditions
  • Overactive Bladder
  • Urge Incontinence
  • Urinary Incontinence
  • Urinary Frequency/Urgency

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline injection visit (week 0) and then at 6 weeks and 12 weeks following intervention for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Response to the Treatment Benefit Scale (TBS) Questionnaire
Secondary outcome measures
Change in International Consultation on Incontinence Questionnaire - short form
Urinary Bladder
Change in Voiding Diary Symptoms - number of mean daily micturition episodes
+1 more
Other outcome measures
Assessment of post void residual
Tolerability of the Procedure using the Procedural Pain Questionnaire

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

Find a Location

Who is running the clinical trial?

Society for Urodynamics & Female Urology FoundationUNKNOWN
Stanford UniversityLead Sponsor
2,448 Previous Clinical Trials
17,492,379 Total Patients Enrolled
Amy D. Dobberfuhl, M.D.Principal InvestigatorStanford University
1 Previous Clinical Trials
5 Total Patients Enrolled
~2 spots leftby Sep 2025
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