CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 194 enrolled
Drug / intervention
Kranus Micteradevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06389838
NCT06389838N/ACompleted

Prospektiv Randomisierte Studie Zur Multimodalen Selbstbehandlung Von Frauen Mit Inkontinenzbeschwerden Mit Einer Digitalen Gesundheitsanwendung

Kranus Health GmbH·interventional·Posted Apr 29, 2024·Updated Apr 28, 2026

In Brief

A clinical study evaluating Kranus Mictera for Urinary Incontinence,Stress and 4 related conditions. Completed, enrolled 194 participants across 1 site.

Detailed Summary

This study, titled "Prospective Randomized Study on Multimodal Self-Treatment for Women with Incontinence Symptoms Using a Digital Health Application," abbreviated as DINKS, aims to investigate the efficacy of a digital health application in treating incontinence in women. The study involves a single-center, single blinded, randomized, controlled trial with two arms: one receiving digital therapy intervention and the other serving as a control group with standard of care. The primary objective is to reduce the frequency of incontinence episodes over a 12-week intervention period, with secondary goals including improvements in disease symptoms, quality of life, and patient activation. The study plans to recruit 198 female participants and assess various endpoints related to incontinence severity, quality of life, and treatment outcomes.

Study Details

Timeline

N/ACompletedFinished
20252026
First PostedApr 29, 2024
Enrollment StartApr 30, 2024
Primary CompletionDec 6, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.2 years ago

Interventions

Kranus Micteradevice

An app-based digital therapy program aimed at multimodal self-treatment for incontinence. The app is certified class I medical device (MDR).