Clinical trial NCT00461292: Safety and Efficacy Study of Botulinum Toxin Type A for the Treatment of Neurogenic Overactive Bladder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Overactive Bladder
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-04-17
Enrollment: 275
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and effectiveness of botulinum toxin type A in treating overactive bladder in spinal cord injury or multiple sclerosis patients


Eligibility criteria: Inclusion Criteria:

* Urinary incontinence as a result of neurogenic overactive bladder due to spinal cord injury or multiple sclerosis
* Inadequate response to anticholinergic medication used to treat overactive bladder

Exclusion Criteria:

* History or evidence of pelvic or urologic abnormality
* Previous or current diagnosis of bladder or prostate cancer
* Urinary tract infection at time of enrollment

Primary outcomes:
measure: Change From Baseline in Number of Weekly Episodes of Urinary Incontinence
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change From Baseline in Maximum Cystometric Capacity (MCC)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Maximum Detrusor Pressure (MDP)
timeFrame: Baseline, Week 6
measure: Change From Baseline in Total Score on Incontinence Quality of Life (I-QOL) Questionnaire
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Middlebury
country: United States
state: Connecticut
city: Rio de Janeiro
country: Brazil
city: Victoria
country: Canada
state: British Columbia
city: Salouel
country: France
city: Milan
country: Italy
city: Amsterdam
country: Netherlands
city: Porto
country: Portugal
city: Singapore
country: Singapore
city: Pretoria
country: South Africa
city: Tenerife
country: Spain
city: Hualien
country: Taiwan
city: Scunthorpe
country: United Kingdom
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Cuervo J, Castejon N, Khalaf KM, Waweru C, Globe D, Patrick DL. Development of the Incontinence Utility Index: estimating population-based utilities associated with urinary problems from the Incontinence Quality of Life Questionnaire and Neurogenic Module. Health Qual Life Outcomes. 2014 Oct 8;12:147. doi: 10.1186/s12955-014-0147-7.
citation: Sussman D, Patel V, Del Popolo G, Lam W, Globe D, Pommerville P. Treatment satisfaction and improvement in health-related quality of life with onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity. Neurourol Urodyn. 2013 Mar;32(3):242-9. doi: 10.1002/nau.22293. Epub 2012 Sep 10.
citation: Cruz F, Herschorn S, Aliotta P, Brin M, Thompson C, Lam W, Daniell G, Heesakkers J, Haag-Molkenteller C. Efficacy and safety of onabotulinumtoxinA in patients with urinary incontinence due to neurogenic detrusor overactivity: a randomised, double-blind, placebo-controlled trial. Eur Urol. 2011 Oct;60(4):742-50. doi: 10.1016/j.eururo.2011.07.002. Epub 2011 Jul 13.