Research report: Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial

A single 12-week course of therapy delivered through a smartphone app produced substantial and durable improvements in urinary incontinence among women, according to a 48-week follow-up of a randomised controlled trial conducted across Germany. Women who used the certified digital therapeutic, which combines pelvic floor exercises, bladder training, cognitive behavioural strategies and lifestyle guidance, reported sustained reductions in symptom severity and gains in quality of life that persisted throughout follow-up, with the evidence most reliable through 36 weeks after the start of treatment. The findings, published in eClinicalMedicine, extend the evidence base for app-based conservative care for a condition that affects an estimated 25 to 45 percent of adult women worldwide.

The intervention tested was Kranus Mictera, a digital health application certified by the Federal Institute for Drugs and Medical Devices in Germany, a regulatory pathway that requires demonstrated clinical benefit through randomised trials.

In the intervention group, symptom severity scores fell by a mean of 4.09 points at 12 weeks and remained stable across follow-up, ranging from 3.88 to 4.07 points below baseline. Quality-of-life scores rose by a mean of 18.85 points at 12 weeks and stayed within a range of 16.79 to 18.97 points above baseline. The control group, once it began therapy after its 12-week wait, showed comparable improvements, with symptom reductions of 3.23 to 4.20 points and quality-of-life gains of 14.69 to 18.42 points. All of these estimates exceeded the predefined minimal clinically important difference thresholds, with confidence interval lower bounds above those thresholds.

Responder analyses reinforced the durability picture. Using multiple imputation under a missing-at-random assumption, between roughly 72 and 79 percent of participants maintained a clinically meaningful response on at least one of the two outcomes across follow-up. On the symptom severity measure, responder rates in the intervention group ranged from 73.3 to 77.3 percent across post-intervention timepoints, while control group rates ranged from 76.1 to 77.0 percent. On quality of life, intervention group rates ranged from 71.9 to 78.5 percent. No statistically significant between-group differences in responder rates appeared at any time-aligned post-intervention timepoint.

At 12 weeks after starting, the adjusted mean difference in symptom severity between the immediate and delayed groups was small and not statistically significant, while a modest quality-of-life difference favouring the immediate group was observed but attenuated and lost significance at later timepoints. The authors stress that no non-inferiority margin was prespecified and the trial was not powered for this comparison, so the estimates describe what was observed and cannot establish that delayed initiation preserves effectiveness. Notably, the waiting group’s severity distribution was essentially unchanged during the delay, and the authors emphasise that waiting times for care should still be minimised.

Two exploratory findings attracted particular attention. First, analyses of objective backend usage data from 179 participants found no correlation between app usage intensity and clinical improvement at any timepoint, a pattern the authors interpret as suggesting a possible threshold effect in which initiating behaviour change matters more than practice intensity. If confirmed prospectively, this could reduce patient burden and lower barriers to adoption. Second, about two-thirds of participants with available data at the late visits, 65.8 percent at week 36 and 64.6 percent at week 48, reported continuing pelvic floor exercises independently without app support, suggesting a transition to self-management. New continence-related treatments were rarely initiated during follow-up, supporting the idea that the sustained effects were not driven by additional therapies.

Important limitations temper the conclusions. Data availability declined progressively, from 95.9 percent of participants at week 12 to 34.0 percent at week 48, and at the final calendar timepoint only 27 of 96 intervention group and 39 of 98 control group participants provided observed data, making the 48-week estimate single-arm, exploratory and hypothesis-generating. The authors report that loss to follow-up was largely unrelated to baseline severity, quality of life or early treatment response, and sensitivity analyses using complete-case and mixed-model approaches yielded consistent results, but informative dropout cannot be excluded. The trial also lacked an active comparator such as supervised in-person physiotherapy, collected no objective measures such as pad weights at follow-up, and recruited a cohort that was predominantly born in Germany and required smartphone ownership, limiting generalisability. The funder, Kranus Health GmbH, sponsored the trial, provided the app and employed four of the authors.

Within those constraints, the study offers the longest reported follow-up, according to its authors, of a nationally certified multimodal digital therapeutic for urinary incontinence spanning all subtypes, and the first to examine delayed versus immediate access and objective usage-response relationships in this setting. The improvements observed, symptom reductions of roughly 3.7 to 4.1 points sustained through 36 weeks, align with previous long-term digital intervention studies reporting sustained gains of 2.2 to 4.0 points at follow-ups of four months to two years. The authors caution that whether digital therapeutics can reduce progression to surgery remains an open question requiring prospective trials with surgical referral as a prespecified endpoint, and that future research should identify predictors of response, compare different delay durations, evaluate cost-effectiveness and validate the findings in more diverse populations. For now, the results support app-based multimodal therapy as a promising conservative option whose privacy and scalability may help address the stigma that keeps fewer than half of affected women from seeking professional care.

Subject of Research: Long-term follow-up of a randomised trial of app-based multimodal therapy for female urinary incontinence

Article Title: Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial

Article References: Frey, L., Haferkamp, A., Lehmacher, W., Duwe, G., Börner, J. H., Brocker, K. A., Ratz, L., Moldovan, D., Krieger, J. E., Miller, K., Wiemer, L., & Papp, C. P. (2026). Long-term effectiveness of app-based therapy for female urinary incontinence: 48-week follow-up of a randomised controlled trial. eClinicalMedicine, 101, Article 104298. https://doi.org/10.1016/j.eclinm.2026.104298

Image Credits: AI Generated

DOI: 10.1016/j.eclinm.2026.104298

Keywords: urinary incontinence, digital therapeutics, randomised controlled trial, pelvic floor training, women's health, mobile health app, ICIQ-UI-SF, quality of life, Germany, self-management, bladder training, clinical follow-up