This is a Prospective, Randomized, Double-Blind Study Comparing Intravesical Injection of Botox® to Placebo. (BTX0621)
Recruitment status was Recruiting
The current study will investigate the comparative efficacy, safety and patient satisfaction of intradetrusor injections BOTOX® injections (200U) versus placebo (saline) injections in the treatment of OAB secondary to benign prostatic obstruction (BPO).
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Safety and Efficacy Study of Intradetrusor Injections of Botox® for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction (BTX0621)|
- Safety and efficacy of BOTOX to placebo (saline) in the treatment of OAB secondary to BPO. [ Time Frame: 6 months post injection ]
- Patient satisfaction to intradetrussor injection of Botox versus placebo. [ Time Frame: 6 months post injection ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||May 2007|
Overactive bladder is a common problem that follows chronic prostatic bladder outlet obstruction and is part of the benign prostatic hyperplasia syndrome (BPH) in men. Unfortunately, it does not often resolve after treatment (TURP, etc) of the obstruction from enlarged prostate gland. Patients with obstructive BPH typically commence treatment with alpha-blockers or anticholinergic agents; the former being used to treat enlarged prostate medically, and the latter to treat overactive bladder symptoms. However, as mentioned, anticholinergics cause many intolerable side effects leading to discontinuation in many patients. Furthermore this class of drug is still considered a relative contraindication in this population by some clinicians. Therefore other modalities need to be studied in these men.
Based on numerous studies in overactive bladder (OAB), we hypothesize that these patients will experience significant improvement (particularly if their symptoms of urgency and frequency) without significant side effects from intradetrusor injections of BOTOX® even though they have were refractory to systemic anticholinergics.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00479596
|Contact: Leonard S Marks, M.D.||(310) firstname.lastname@example.org|
|Contact: Malu Macairan, M.D.||(310) email@example.com|
|United States, California|
|Urological Sciences Research Foundation||Recruiting|
|Culver City, California, United States, 90232|
|Contact: Malu Macairan, M.D. 310-838-6347 firstname.lastname@example.org|
|Contact: Anthony Cancio (310) 838-6347 email@example.com|
|Principal Investigator: Leonard S Marks, M.D.|
|Principal Investigator:||Leonard S Marks, M.D.||Urological Sciences Research Foundation|