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Botulin-A Toxin Instillations and Overactive Bladder

NCT00583219 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2014-04-21

Study results available
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Summary

The primary objective of this pilot study is to evaluate the safety and efficacy of direct instillations of Botulinum-A toxin/DMSO into the bladder via a catheter system as a means of treating women with symptoms of overactive bladder and secondary urinary incontinence. In doing so, we will focus on estimating the percentage of women who experience an improvement in their urinary incontinence symptoms at one month and three months following this novel instillation technique.

Conditions

Interventions

DRUG

Botulinum-A toxin

A simple bladder catheterization in the office with a standard urinary catheter and instill the Botulinum-A toxin/DMSO solution.

DRUG

Dimethyl sulfoxide (DMSO)

Subjects received 50 cc of DMSO in an aqueous solution for intravesical instillation with botulinum-A toxin. Each cc contained 0.54 gm DMSO.

Sponsors & Collaborators

Principal Investigators

  • Steven Petrou, MD · Mayo Clinic

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-05-31
Completion
2008-05-31

Countries

  • United States

Study Locations

More Related Trials

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 NCT00583219 on ClinicalTrials.gov