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Intravesical Botulinum Toxin A Injections in Treatment of Interstitial Cystitis Refractory to Conventional Treatment

NCT01969773 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-02-17

No results posted yet for this study

Summary

This study was designed in a multicenter, randomized, double-blind, placebo controlled trial to test the actual therapeutic effects of intravesical BoNTA injection. The results of this study might provide clinical evidence for a better therapeutic regimen in the treatment of IC/PBS.

Conditions

  • Interstitial Cystitis

Interventions

DRUG

Botulinum toxin A

Patients will be randomly assigned to receive intravesical injection of 100U of BoNT-A (BOTOX, Allergan, Irvine, CA, USA)

DRUG

Normal saline instillation

Patients will be randomly assigned to receive intravesical injection of injection with normal saline.

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
QUADRUPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2012-12-31
Primary Completion
2014-12-31
Completion
2014-12-31
FDA Drug
Yes

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 NCT01969773 on ClinicalTrials.gov