A Randomized Trial of an App-Based Therapeutic for Lower Urinary Tract Symptoms
Abstract
BACKGROUND
Male lower urinary tract symptoms (LUTS) increase with age and negatively impact quality of life. Conservative treatment with physiotherapeutic approaches and changes in lifestyle are often neglected. App-based therapeutics may have some benefits for patients with LUTS.
METHODS
In this prospective, two-center, single-blinded trial, men with LUTS were randomly assigned 1:1 to either an intervention group with access to an app-based therapeutic in addition to their usual medical care or a control group receiving only their usual medical care. The primary end point was symptom improvement (change from baseline to week 12) as measured by the International Prostate Symptom Score (IPSS; range 0 to 35, with higher scores indicating more severe symptoms; minimal clinically important difference of 3). Secondary end points included symptom improvement, as measured by the Overactive Bladder Questionnaire - Short Form part 1 (OAB-q-SF symptom bother, six items; range 6 to 36, transformed to a scale from 0 to 100, with higher scores indicating more severe symptoms), and health-related quality of life (HRQOL), as measured with the OAB-q-SF part 2 (13 items; range 13 to 78, transformed to a scale from 0 to 100 with higher scores indicating better HRQOL).
RESULTS
A total of 237 patients were randomly assigned, with seven participants subsequently dropping out. The mean age (± standard deviation [SD]) was 58.4 (12.3) years; 46.4% had benign prostatic enlargement alone, 22.4% had…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 237 participants or records.
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