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

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.

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).

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.

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.).