Refractory Urge Incontinence and Botox Injections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-06-30

Study Completion Date

2007-12-31

Brief Summary

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The purpose of this study is to see whether Botox A (injected into the bladder muscle) can improve symptoms of urge incontinence that has not improved with usual medical treatments.

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Detailed Description

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Women who suffer with urge incontinence may not get relief with usual medical treatment (such as medications or behavioral techniques). We plan to enroll women with refractory urge incontinence in centers across the US. Study participants will undergo cystoscopy (telescope look into the bladder) and injection of either Botox A or placebo. If symptoms are not adequately relieved, subjects participants will receive a second injection that is Botox A. Participants are interviewed monthly by study personnel to determine symptoms and health status.

Conditions

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Urinary Incontinence Detrusor Overactivity Urinary Urgency Urge Urinary Incontinence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Botox A

up to two injections of 200 Units of intra-detrusor Botulinum Toxin A , which must be separated by at least eight weeks and no more than 52 weeks

Group Type EXPERIMENTAL

Botulinum Toxin A, bladder detrusor muscle injection

Intervention Type DRUG

200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.

Placebo

up to two injections of inactive injection (carrier saline), which must be separated by at least eight weeks and no more than 52 weeks

Group Type PLACEBO_COMPARATOR

Vehicle saline as placebo

Intervention Type DRUG

A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices

Interventions

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Botulinum Toxin A, bladder detrusor muscle injection

200 U provided as a total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices.

Intervention Type DRUG

Vehicle saline as placebo

A total of 6 cc of the masked substance into approximately 15 to 20 different detrusor muscle sites under direct visualization. Injections will be spread out to equally cover the entire dome of the bladder, but spare the bladder trigone and ureteral orifices

Intervention Type DRUG

Other Intervention Names

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Botox

Eligibility Criteria

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Inclusion Criteria

* Adult women
* Detrusor overactivity incontinence confirmed by urodynamic testing
* Symptoms refractory to standard first- and second-line treatments
* 6 or more urge incontinence episodes on 3-day bladder diary
* Normal neurological examination

Exclusion Criteria

* Urinary retention
* Allergy to Botox (Botulinum Toxin A)
* Previous bladder treatment with Botox (Botulinum Toxin A) in the past year
* Pregnancy or planning pregnancy within next year
* Neurologic disease with impaired neurotransmission

Minimum Eligible Age

21 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No