Ignite Creation Date:
2024-05-05 @ 5:33 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00479596
Status:
UNKNOWN
Last Update Posted:
2007-05-30
First Post:
2007-05-25
Brief Title:
This is a Prospective Randomized Double-Blind Study Comparing Intravesical Injection of Botox to Placebo
Sponsor:
Urological Sciences Research Foundation
Organization:
Urological Sciences Research Foundation
Study Overview
Official Title:
Safety and Efficacy Study of Intradetrusor Injections of Botox for the Treatment of Urinary Incontinence Secondary to Benign Prostatic Obstruction BTX0621
Status:
UNKNOWN
Status Verified Date:
2007-01
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BTX0621
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None