drugset / Trial / NCT03076762

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

NCT03076762 ↗

Phase 2 Unknown 60 enrolled Buddhist Tzu Chi General Hospital
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2015-03
Primary completion
2017-08
Completion
2017-08

Outcome

Missed primary endpoint

paper Thirteen (65.0%) patients in bladder body group and 10 (52.6%) patients in trigone group had decrease of VAS more than 2 points after treatment (P = 0.43). PMID 29331031 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 100 iu Intravenous

Indications