Randomized Trial for Botox Urinary Incontinence

NCT00178191 | Completed Results DMC

• 2 other identifiers: 104661R21AG025490-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

• Episodes/Day

  number of incontinence episodes/day

  9 months

Study Arms (3)

200 units Botox

EXPERIMENTAL

200 units Botulinum-A toxin

Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: Pad weight

300 units Botox

EXPERIMENTAL

300 units Botulinum-A toxin

Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: Pad weight

Placebo

PLACEBO COMPARATOR

Placebo

Other: Bladder diary; Other: Questionnaires; Procedure: Urodynamics; Other: Pad weight

Interventions

Bladder diary OTHER

3-day bladder diary

200 units Botox; 300 units Botox; Placebo

Questionnaires OTHER

Incontinence Quality of Life questionnaires

200 units Botox; 300 units Botox; Placebo

Urodynamics PROCEDURE

Urodynamics

200 units Botox; 300 units Botox; Placebo

Pad weight OTHER

Pad weight

200 units Botox; 300 units Botox; Placebo

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• National Institutes of Health (NIH): collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

University of Rochester

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Urinary Incontinence

Interventions

Surveys and Questionnaires; Urodynamics

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Urinary Tract Physiological Phenomena; Reproductive and Urinary Physiological Phenomena

Limitations and Caveats

Please see published manuscripts for additional details

Results Point of Contact

• Title: Michael Flynn
• Organization: University of Rochester

Michaelk_flynn@urmc.rochester.edu

585-273-3232

Study Officials

• Michael K Flynn, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: September 12, 2005
• First Posted: September 15, 2005
• Study Start: June 1, 2005
• Primary Completion: July 1, 2008
• Study Completion: July 1, 2008
• Last Updated: October 3, 2011
• Results First Posted: August 3, 2009

Record last verified: 2011-09

Locations

US (1)