Trial reportFrontiers in digital health2026
A randomized, unblinded, controlled clinical study to assess the mobile digital health application INKA in the management of therapy refractory overactive bladder and mixed incontinence.
Trial report in Frontiers in digital health, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
0 citing papers in PubMed.
No citing paper in PubMed yet.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Background: This exploratory, two-arm, randomized, unblinded, controlled, multicentre study assessed the health benefits of the INKA app, a MDR class I CE-marked digital therapy companion for patients with overactive bladder (OAB) and mixed incontinence (MI). INKA offers self-guided educational, behavioural, and motivational content, along with physiotherapy modules and supports daily self-management, in accordance with current clinical guidelines. Methods: 251 patients under first-line stable pharmacological treatment were recruited at 35 study sites in Germany and randomized to receive access to the INKA app or standard of care alone (the control group). Self-assessed OAB related endpoints were investigated at baseline, after 4 and after 12 weeks. The end-of-study visit was conducted on site. Results: Among 111 evaluable patients (43 INKA, 68 control), baseline characteristics were comparable (mean age 52.7 years, SD 14.6; 27% male, 73% female). 55% of INKA users engaged with the app on a daily basis. At 12 weeks, the INKA group showed a mean reduction of -1.02 (SD 3.36) micturitions per 24 h compared to +0.08 (SD 2.97) in the control group. Significant and clinically meaningful improvements were observed in female INKA users and those with heightened symptom severity. A significant mean increase in urine volume per micturition was noted in the INKA group (+15.75 mL, SD 49.74) vs. the control group (-8.84 mL, SD 52.14), in "OAB wet" and in the female subgroup. The ICIQ-OAB questionnaire results indicated favourable outcomes for all groups, with all INKA patients and the female subgroup showing clinically relevant symptom relief. Additionally, greater improvement on the ICIQ-OABqol questionnaire was reported for the INKA group (-12.5, SD 20.17) vs. the control group (-7.89, SD 20.15). No INKA-related adverse events or device deficiencies were reported. Conclusion: This proof-of-concept study highlights the potential of the INKA mobile app to reduce micturition frequency and increase the micturition volume in therapy refractory OAB patients, both recognized as key factors of OAB symptom burden. A forthcoming trial will evaluate an optimized and more user-friendly version of the app with patients with a higher symptom severity at baseline. Clinical Trial Registration: German Clinical Trials Register (DRKS ID 00029329).
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.