Randomized Trial for Botox Urinary Incontinence - Full Text View

Sponsor:	University of Rochester
Collaborator:	National Institutes of Health (NIH)
Information provided by:	University of Rochester
ClinicalTrials.gov Identifier:	NCT00178191

Purpose

The purpose of this study is to determine how effective Botox is in reducing the amount of urine leaked and which dose of Botox is more effective and safe in those who have urinary urge incontinence.

Condition	Intervention
Urinary Incontinence	Other: Bladder diary Other: Questionnaires Procedure: Urodynamics Other: Pad weight

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Randomized Trial of Botox for Severe Urge Incontinence

Resource links provided by NLM:

MedlinePlus related topics: Botox Urinary Incontinence Urine and Urination

U.S. FDA Resources

Further study details as provided by University of Rochester:

Primary Outcome Measures:

Episodes/Day [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	June 2005
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
200 units Botox: Experimental 200 units Botulinum-A toxin	Other: Bladder diary 3-day bladder diary Other: Questionnaires Incontinence Quality of Life questionnaires Procedure: Urodynamics Urodynamics Other: Pad weight Pad weight
300 units Botox: Experimental 300 units Botulinum-A toxin	Other: Bladder diary 3-day bladder diary Other: Questionnaires Incontinence Quality of Life questionnaires Procedure: Urodynamics Urodynamics Other: Pad weight Pad weight
Placebo: Placebo Comparator Placebo	Other: Bladder diary 3-day bladder diary Other: Questionnaires Incontinence Quality of Life questionnaires Procedure: Urodynamics Urodynamics Other: Pad weight Pad weight

Detailed Description:

The prevalence of urinary incontinence in the US ranges from 3-14% with epidemiologic estimates ranging widely.1 Most urinary incontinence can be categorized into stress urinary incontinence (SUI) or UUI with UUI remaining more common and debilitating than SUI.2 A major cause of UUI is overactive bladder or detrusor instability (DI), and while DI is very common, its etiology remains unknown. DI is often successfully managed with behavioral therapy, physical therapy, medications and surgery with the most effective therapy being anticholinergic medication.2 However, side effects including dry mouth, and constipation often lead to discontinuation of these drugs. In addition, many patients fail anticholinergic medication and have persistent urinary leakage. Women who fail these treatments have limited options.

Eligibility

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria: Subjects must have ALL of the following:

Completed a routine evaluation of incontinence (urodynamics, bladder diaries, and pad weights) through the urogynecology clinic at SMH within 3 months of the screening visit
Symptoms of urge incontinence associated with leakage on bladder diary
24-hour pad weight >100 cc's (volume requiring multiple daily diaper changes)
Absence of a bladder infection or other condition that could explain urinary leakage
Absence of stress incontinence or a cough leak point pressure > 100 cm H2O on cystometry (this correlates with mild stress incontinence)
Failed anticholinergic therapy
Willingness and ability to perform intermittent clean catheterization (due to the risk of prolonged urinary retention from Botox)
The ability and willingness to return for surveillance evaluations
A negative urine pregnancy test if at risk for pregnancy
Competent to give signed consent and complete all of the study measures

Exclusion Criteria:

Children (< 21 years old), pregnant women and prisoners
History of carcinoma of the bladder
Absence of a measurable detrusor contraction on a pressure flow micturition study
A foreign body in the bladder or other correctable etiology for the UUI
Prior documented resistance to Botox
Gross fecal incontinence (due to confounding effects on pad weights and counts)
Known allergy to lidocaine or related compounds (used for local analgesia)
Known allergy to or inability to take both Bactrim DS or Ciprofloxacin (used for urinary tract infection prophylaxis)
Current use of an aminoglycoside or preparing for general anesthesia within 1 week (risk of synergetic effects
Known neurologic conditions such as Parkinson's disease, myasthenia gravis, multiple sclerosis, autonomic dysfunction, Lambert-Eaton syndrome, Amyotrophic Lateral Sclerosis or other neurologic disorder that may impact urinary function or the effect of Botox.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00178191

Locations

United States, New York
University of Rochester
Rochester, New York, United States, 14642

Sponsors and Collaborators

University of Rochester

National Institutes of Health (NIH)

Investigators

Principal Investigator:

Michael K Flynn, MD

University of Rochester

More Information

No publications provided

Responsible Party:	University of Rochester ( Michael K. Flynn, MD )
Study ID Numbers:	10466
Study First Received:	September 12, 2005
Results First Received:	June 12, 2009
Last Updated:	July 31, 2009
ClinicalTrials.gov Identifier:	NCT00178191 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Signs and Symptoms
Urological Manifestations
Urologic Diseases
Urination Disorders
Urinary Incontinence

ClinicalTrials.gov processed this record on February 08, 2010