A Randomized Trial of an App-Based Therapeutic for Lower Urinary Tract Symptoms.

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 benign prostatic enlargement combined with overactive bladder, and 31.2% had overactive bladder alone. Compared with the control group, the intervention group showed significantly greater improvement in the primary end point (least- squares mean [LSM], -7.0 points; 95% confidence interval [CI], -8.1 to -5.9; P<0.001) and the secondary end points OAB-q-SF part 1 (symptom bother, LSM -18.; 95% CI, -22.2 to -15.0; P<0.001) and part 2 (health-related quality of life, LSM +17.2; 95% CI, 14.2 to 20.2; P<0.001). A total of 12 patients (10.7%) had at least one adverse event in the intervention group compared with five patients (4.0%) in the control group. There were five patients (4.5%) with serious adverse events (SAEs) in the intervention group and one patient (0.8%) with SAEs in the control group.

Conclusions: This randomized trial demonstrated significant symptom improvement measured by the IPSS for patients with LUTS using app-based therapeutics compared with usual care. Additional symptom scores and quality of life also significantly improved in patients with LUTS with the use of app-based therapeutics. (Funded by Kranus Health GmbH; German Clinical Trials Registry number, DRKS00030935.).