CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 90 enrolled
Drug / intervention
BoNT-A (10 injection) +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01657409
NCT01657409Phase 2Completed

Comparison of the Therapeutic Effects of Different Injection Number of the Same Dose of Botulinum Toxin A on Overactive Bladder Syndrome

Buddhist Tzu Chi General Hospital·interventional·Posted Aug 6, 2012·Updated Feb 15, 2017

In Brief

A Phase 2 clinical trial evaluating BoNT-A (10 injection), BoNT-A (20 injection), and 1 other intervention for Overactive Bladder. Completed, enrolled 90 participants across 1 site.

Detailed Summary

Overactive bladder (OAB) is a symptom syndrome characterized by urgency frequency with or without urge urinary incontinence (UUI) that may affect the patients' quality of life. Current medical treatments are usually unsuccessful in completely eradicating urgency sensation. Intra-detrusor injection of botulinum toxin A (BoNT-A) modulates the release of neurotransmitters from sensory nerve endings and effectively modulates the inflammatory process mediated by nociceptive afferent nerve dysfunction. Satisfactory clinical results were achieved with intravesical BoNT-A injection, which increased bladder capacity and decreased urgency sensation in patients with neurogenic or idiopathic detrusor overactivity (NDO, IDO). Excellent results were achieved with injection of either 100 U or 200 U of BoNT-A. Episodes of frequency, urgency, and UUI were reduced, maximal cystometric capacity increased, maximal detrusor pressure (Pdet) decreased, and the quality of life index also improved significantly. However, post void residual (PVR) volume increased significantly and some patients required clean intermittent catheterization (CIC) to evacuate the PVR. Dose-related adverse events (AE) increased with increasing dose of BoNT-A. Therefore, adjustments of the BoNT-A dose and sites of injection might minimize the de novo AE and help to maintain success rates.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan
Collaborators--

Timeline

Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 6, 2012
Enrollment StartAug 1, 2012
Primary CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 13.9 years ago

Interventions

BoNT-A (10 injection)drug

BoNT-A 100 U 10 injections

BoNT-A (20 injection)drug

BoNT-A 100 U 20 injections

BoNT-A (40 injection)drug

BoNT-A 100 U 40 injections