Who is sponsoring NCT03076762?

NCT03076762 is sponsored by Buddhist Tzu Chi General Hospital.

What condition does NCT03076762 study?

NCT03076762 studies Bladder Pain Syndrome.

What drugs are being tested in NCT03076762?

Interventions: intravesical onabotulinumtoxinA injection.

What is the status of NCT03076762?

NCT03076762 is currently UNKNOWN.

Last reviewed 2017-04-06 · How we verify

Comparative Study of the Efficacy and Safety Between Suburothelial and Trigonal Intravesical Botulinum Toxin A Injection in Treatment of Interstitial Cystitis Refractory to Conventional Treatment - A Prospective, Randomized, Clinical Trial

NCT03076762 Phase 2 UNKNOWN

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.

Details

Lead sponsor	Buddhist Tzu Chi General Hospital
Phase	Phase 2
Status	UNKNOWN
Enrolment	60
Start date	2015-03
Completion	2017-08

Conditions

Bladder Pain Syndrome

Interventions

intravesical onabotulinumtoxinA injection

Primary outcomes

Reduction of bladder pain visual analog scale (VAS) — baseline to 8 weeks
Evaluation of the change of VAS from baseline to 8 weeks

Countries

Taiwan