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

NCT06389838 | Completed Results

• 3 other identifiers: DINKS01DRKS000337042024-512094-27
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Urinary Incontinence; Mobile Health; Digital therapeutics; Pelvic Floor exercises; bladder control; digital health; app based therapy; behavioral intervention; quality of life

Outcome Measures

Primary Outcomes (1)

• Incontinence Episodes

  Relative change (rel-CfB-IEF) of IEF from baseline to week 12 relative to baseline; desired reduction in mean relative IEF by 50%; IEF per 24 hours - averaged over 72 hours.

  12 weeks

Secondary Outcomes (13)

• International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)

  12 weeks

• Incontinence Quality-of-Life (I-QOL)

  12 weeks

• Patient Activation Measure-13 (PAM-13)

  12 weeks

• Patient Global Impression of Improvement (PGI-I)

  12 weeks

• Cured Patients

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care

Device: Kranus Mictera

Control

NO INTERVENTION

Participants will continue with their therapy treatment (standard of care) if they are on it for more that four weeks before inclusion. Beginning of new therapies during the study is not allowed.

Interventions

Kranus Mictera DEVICE

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

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 years or older.
• Diagnosis of urinary incontinence, including stress incontinence, urge incontinence, or mixed incontinence.
• Mastery of the German language.
• Access to the internet.
• Access to a tablet or smartphone (Android not older than version 7 and iPhone not older than iPhone 9).
• Ability to provide informed consent

You may not qualify if:

• Acute cystitis (N30.0)
• Bladder stones (N21.0)
• Recurrent, uncontrollable macrohematuria (R31)
• Newly diagnosed bladder carcinoma \< 3 months (C67)
• Inability to physically participate in the therapy program
• Active pregnancy
• Bladder botulinum toxin treatment within the last 6 months
• Patients unable to understand and independently sign the consent form
• Initiation of new medication or physical therapy for urinary symptoms within the last 4 weeks
• Severe psychiatric disorders hindering app usage
• Neurological disorders affecting the urinary tract
• Incontinence or tumor surgeries in the pelvic area
• Severe obesity (BMI \>35)
• Recurrent urinary tract infections (at least 2 within 6 months or 3 within a year)

Sponsors & Collaborators

• Kranus Health GmbH: lead
• Johannes Gutenberg University Mainz: collaborator

Study Sites (1)

Clinic of Urology

Mainz, Germany, 55131, Germany

Location

Related Publications (1)

• Haferkamp A, Frey L, Duwe G, Borner JH, Hunfeld C, Brocker KA, Troilo S, Lehmacher W, Papp CP, Miller K, Wiemer L. App-based therapy for female patients with urinary incontinence in Germany (DINKS): a single-blind, randomised, controlled trial. Lancet Digit Health. 2025 Dec;7(12):100935. doi: 10.1016/j.landig.2025.100935. Epub 2025 Dec 16.

  PMID: 41407582 RESULT

Related Links

• Kranus webpage for the medical device

MeSH Terms

Conditions

Urinary Incontinence, Stress; Urinary Incontinence, Urge; Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Kranus Health GmbH

medical@kranushealth.com

+491756939818

Study Officials

• Axel Haferkamp, PhD

  Director of the Clinic of Urology, University of Mainz , Germyny

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: Participants know which group they are assigned to, but the investigators are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, randomized, controlled, single-blinded, 2-arm design

Study Record Dates

• First Submitted: April 25, 2024
• First Posted: April 29, 2024
• Study Start: April 30, 2024
• Primary Completion: December 6, 2024
• Study Completion: December 6, 2024
• Last Updated: April 28, 2026
• Results First Posted: June 13, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)