CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 20 enrolled
Drug / intervention
Cystoscopic injection of Botox into the urinary bladderdrug
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/NCT01421719
NCT01421719Phase 4Completed

Onabotulinum Toxin Type A (BTX-A) For Treatment of Neurogenic Overactive Bladder Due to Parkinson's Disease: Safety and Efficacy

Stanford University·interventional·Posted Aug 23, 2011·Updated Mar 10, 2017

In Brief

A Phase 4 clinical trial evaluating Cystoscopic injection of Botox into the urinary bladder for Parkinson's Disease and 3 related conditions. Completed, enrolled 20 participants across 1 site.

Detailed Summary

The basic nerve deficit of Parkinson's disease (PD) leads to lower urinary tract symptoms of frequency, urgency and urge urinary incontinence. Lower urinary tract symptoms tend to occur at more advanced stages of PD. In the over-65 year old age group, where 1% of men suffer from this disease, they are also prone to development of benign prostatic hyperplasia (BPH) and consequent associated lower urinary tract dysfunction. Similarly the over 65-year age group develop spontaneous overactive bladder up to a prevalence of 30% of both men and women. The urologic disorder is exceedingly devastating in reducing the quality of life in these individuals due to the lower urinary tract symptoms and ultimate urinary incontinence in a high proportion of patients. While attempts at pharmacologic treatment are partially satisfactory many patients are intolerant of oral drugs. Botulinum-A neurotoxin (BTX-A) has been shown in pilot trials to be quite effective in reducing overactive bladder symptoms and is specifically beneficial for a wide-variety of neurogenic bladder causes of over activity . The treatment procedure of injecting the detrusor muscle of the bladder with BTX-A is quite simple, does not impose significant risks to the patient, and can be performed as an office urologic procedure. This pilot clinical trial intends to demonstrate the safety and efficacy of low-dose Botox-A injections into the bladder to improve urinary symptoms in 20 patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsAllergan

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedAug 23, 2011
Enrollment StartFeb 1, 2009
Primary CompletionMay 1, 2011
Study CompletionJul 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 14.9 years ago

Interventions

Cystoscopic injection of Botox into the urinary bladderdrug

100 U of Botox A injected transurethrally into the urinary bladder muscle and submucosa.