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Transvaginal Botulinum Toxin A Chemodenervation for Overactive Bladder

NCT05463822 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2022-07-19

No results posted yet for this study

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.

Conditions

  • Overactive Bladder
  • Bladder, Overactive
  • Urge Incontinence
  • Urgency Urinary
  • Urinary Frequency/Urgency

Interventions

DRUG

Transvaginal botulinum toxin A (BTA) injection

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.

Sponsors & Collaborators

  • Society for Urodynamics & Female Urology Foundation

    collaborator UNKNOWN

  • Stanford University

    lead OTHER

Principal Investigators

  • Amy D. Dobberfuhl, M.D. · Stanford University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-06-20
Primary Completion
2021-09-27
Completion
2021-09-27
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05463822 on ClinicalTrials.gov