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RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application

NCT06389838 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 194

Last updated 2026-04-28

Study results available
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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.

Conditions

  • Urinary Incontinence,Stress
  • Urinary Incontinence, Urge
  • Urinary Incontinence
  • Overactive Bladder Syndrome
  • Female Urinary Stress Incontinence

Interventions

DEVICE

Kranus Mictera

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

Sponsors & Collaborators

  • Johannes Gutenberg University Mainz

    collaborator OTHER

  • Kranus Health GmbH

    lead INDUSTRY

Principal Investigators

  • Axel Haferkamp, PhD · Director of the Clinic of Urology, University of Mainz , Germyny

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-30
Primary Completion
2024-12-06
Completion
2024-12-06

Countries

  • Germany

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06389838 on ClinicalTrials.gov