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Comparative Study Suburothelial and Trigonal Botulinum Toxin A Injection in Treatment of Interstitial Cystitis

NCT03076762 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-04-07

No results posted yet for this study

Summary

There is no consensus of the therapeutic efficacy and safety between suburothelial injection and trigonal injection of botulinum toxin A (BoNT-A) in treatment of interstitial cystitis/bladder pain syndrome (IC/BPS) It is unmet to clarify which injection method is superior in clinical efficacy and patient safety. This study was designed in a randomized, double-blind trial to test the therapeutic effects and adverse events between intravesical BoNTA injection into suburothelium and trigone. The results of this study might provide clinical evidence for a better therapeutic regimen of BoNT-A in the treatment of IC/PBS.

Conditions

  • Bladder Pain Syndrome

Interventions

DRUG

intravesical onabotulinumtoxinA injection

Each vial of onabotulinumtoxinA will be diluted with 10 ml of normal saline, resulting in 10U onabotulinumtoxinA per 1.0 ml. Patients assigned for suburothelial BoNT-A injections received 20 injections in the bladder body whereas those assigned trigonal injections will receive 10 sites injections at the trigonal area (5 injections behind interureteric ridge and 5 inside the trigone).

Sponsors & Collaborators

  • Buddhist Tzu Chi General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2017-08-31
Completion
2017-08-31
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 NCT03076762 on ClinicalTrials.gov