Date of Award

2015

Degree Type

Selective Evidence-Based Medicine Review

Degree Name

Master of Science in Health Sciences - Physician Assistant

Department

Physician Assistant Studies

Department Chair

John Cavenagh, MBA, PhD, PA-C

Abstract

OBJECTIVE: The objective of this selective EBM review is to determine whether or not treatment with onabotulinumtoxinA improves the quality of life in patients with urinary incontinence not adequately controlled with anticholinergics.

STUDY DESIGN: Review of three English language, randomized controlled trials published in 2013.

DATA SOURCES: Randomized, double-blind, controlled clinical trials comparing onabotulinumtoxinA intradetrusor injections with saline placebo. All articles were found using PubMed.

OUTCOMES MEASURED: Each of the three trials assessed the patient’s quality of life after treatment with onabotulinumtoxinA using the following assessment tools: Incontinence Quality of Life Questionnaire (I-QOL), Modified Overactive Bladder Patient Satisfaction with Treatment Questionnaire (OAB-PSTQ), King’s Health Questionnaire (KHQ), Patient Global Assessment (PGA), and Treatment Benefit Scale.

RESULTS: Both the Chancellor et al. and the Sussman et al. studies found a statistically significant improvement in the change from baseline in the I-QOL and OAB-PSTQ for the patients who received onabotulinumtoxinA compared to placebo (p value < 0.001). Nitti et al. demonstrated an improvement range of 19.6 to 23.9 ± SD change from baseline in the I-QOL score for the onabotulinumtoxinA treatment group. 60.8% of the experimental group in Nitti et al. reported a positive treatment response after onabotulinumtoxinA while only 29.2% of placebo patients reported this response (p value < 0.001). Sussman et al established an inverse correlation between I-QOL total scores and UI frequency with a Pearson’s correlation coefficient of -0.508 at week 12 establishing that decreased frequency in urinary incontinence events are associated with improved quality of life.

CONCLUSIONS: Based on the three trials, onabotulinumtoxinA does improve quality of life in patients with urinary incontinence not adequately controlled with anticholinergics by improving patient satisfaction with treatment, urinary incontinence symptoms, and healthcare related quality of life.

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