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Botulinum Toxin Urethral Sphincter Injection for Dysfunctional Voiding

NCT01733290 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2017-03-08

No results posted yet for this study

Summary

This study is designed and aimed at determine the clinical efficacy of BoNT-A on patients with dysfunctional voiding. The results of this study can provide further information for patient selection and therapeutic duration.

Conditions

  • Dysfunctional Voiding

Interventions

DRUG

Botulinum toxin A

A total of 100 units of BoNT-A will be injected deeply into the external sphincter at the 3, 6, 9 and 12 o'clock positions in approximate equal aliquot.

DRUG

Normal saline instillation

Normal saline instillation

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    lead OTHER

Principal Investigators

  • Hann-Chorng Kuo, M.D. · Department of Urology, Buddhist Tzu Chi General Hospital and Tzu Chi University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2017-02-28
Completion
2017-02-28

Countries

  • Taiwan

Study Locations

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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 NCT01733290 on ClinicalTrials.gov