Refractory Urge Incontinence and Botox Injections

Phase 3TerminatedNCT00373789

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)87 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Urinary Incontinence Detrusor Overactivity Urinary Urgency Urge Urinary Incontinence

Interventions

Botulinum Toxin A, bladder detrusor muscle injectionDRUG

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.

Vehicle saline as placeboDRUG

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

Eligibility

Sex: FEMALEMin age: 21 Years

Medical Language ↔ Plain English

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

Locations (8)

University of Alabama

Birmingham, Alabama, United States

USCD Medical Center

La Jolla, California, United States

Kaiser Permanente

San Diego, California, United States

Loyola University

Maywood, Illinois, United States

Outcomes

Primary Outcomes

Time to recurrence of detrusor overactivity incontinence symptoms

To allow sufficient time for the onset of action of botulinum toxin A, the earliest outcome measurement was 60 days after injection. Failure was defined as a patient global impression of improvement (PGI-I) score of 4 or greater, the commencement of any new treatment at any time after the first injection or increased intensity of previously established treatment for DOI.

Time frame: 6 months

Secondary Outcomes

Change in incontinence episode frequency by bladder diary

based on the 3-day bladder diary completed pre-intervention and at 4 weeks post injection. A successful within-subject outcome will be defined as \>75% reduction in the frequency of urge incontinence episodes compared to the baseline frequency.

Time frame: At 12 mos after first injection., but no less than 1 mo after second injection

Incontinence-related and health-related quality of life

measured by the Urinary Distress Inventory subscale of the PFDI/PFIQ, the PISQ, and SF-36 administered at 4 weeks after the initial injection and either prior to any re-treatment or at the completion of study participation, whichever is earlier.

Time frame: At 12 mos after first injection, but no less than 1 mo after second injection.

Voiding dysfunction requiring catheterization

Time frame: throughout 12-month study

Data from ClinicalTrials.gov

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