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

April 25, 2024 updated by: Kranus Health GmbH

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

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The intervention in this study involves a digital therapy program delivered via a smartphone or tablet application. This program includes several components aimed at addressing different aspects of incontinence management:

Voiding Diary: Participants will be instructed to maintain a diary to track their urinary habits, including frequency of voiding, episodes of incontinence, and fluid intake.

Pelvic Floor Exercises and Physiotherapy: The digital therapy program will provide guidance on performing pelvic floor exercises and other physiotherapeutic interventions aimed at strengthening pelvic floor muscles and improving bladder control.

Bladder Training and Cognitive Behavioral Therapy: Participants will receive instructions on bladder training techniques and cognitive behavioral strategies to manage urgency and frequency of urination.

Mental Exercises: The program will include mental exercises such as mindfulness techniques, progressive muscle relaxation, and stimulus control methods to help participants manage stress, anxiety, and other psychological factors contributing to incontinence.

Acute Urgency Management: Strategies for managing acute episodes of urgency and urge incontinence will be provided, including techniques to delay voiding and control bladder spasms.

Educational and Nutritional Guidance: Participants will have access to educational materials and nutritional guidance aimed at optimizing bladder health and overall well-being.

Progress Tracking and Motivation: The application will feature tools for tracking progress, setting goals, and providing motivational feedback to encourage adherence to the intervention.

Overall, the digital therapy program is designed to provide comprehensive support for women with incontinence symptoms, addressing both physical and psychological aspects of the condition to improve symptom severity, quality of life, and patient activation.

Study Type

Interventional

Enrollment (Estimated)

198

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Acute cystitis (N30.0)
  • Bladder stones (N21.0)
  • Recurrent, uncontrollable macrohematuria (R31)
  • Newly diagnosed bladder carcinoma < 3 months (C67)
  • Relative Exclusion Criteria not coded according to ICD-10:
  • Inability to physically participate in the therapy program
  • Active pregnancy
  • Bladder botulinum toxin treatment within the last 6 months
  • Study-specific methodological exclusion criteria:
  • 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 Pelvic surgeries including incontinence surgeries Severe obesity (BMI >35) Recurrent urinary tract infections (at least 2 within 6 months or 3 within a year)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care
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).
No Intervention: Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incontinence episodes
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICIQ-SF
Time Frame: 12 weeks
Change (CfB) in ICIQ-SF from baseline to week 12; expected mean difference between groups of > 2.9 points
12 weeks
I-QoL
Time Frame: 12 weeks
Change in I-QoL from baseline to week 12; expected mean difference between groups of > 6.3 points
12 weeks
PAM-13
Time Frame: 12 weeks
Change in PAM-13 questionnaire from baseline to week 12
12 weeks
PGI-I
Time Frame: 12 weeks
PGI-I questionnaire (overall improvement after treatment) in week 12
12 weeks
Cured patients
Time Frame: 12 weeks
Proportion of patients without incontinence (cured patients) at study end
12 weeks
Urinary frequency day
Time Frame: 12 weeks
Change in urinary frequency during the day from baseline to week 12
12 weeks
Urinary frequency night
Time Frame: 12 weeks
Change in urinary frequency at night from baseline to week 12
12 weeks
Pad use
Time Frame: 12 weeks
Change in pad use from baseline to week 12
12 weeks
Urge incontinence
Time Frame: 12 weeks
Change in urge incontinence from baseline to week 12
12 weeks
Functional bladder capacity
Time Frame: 12 weeks
Change in functional bladder capacity from baseline to week 12
12 weeks
Body weight
Time Frame: 12 weeks
Change in body weight from baseline to week 12
12 weeks
Treatment Failure
Time Frame: 12 weeks
Proportion of patients with treatment failure within the study period
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kranus Health GmbH

Collaborators

Johannes Gutenberg University Mainz

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 29, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

April 25, 2024

First Submitted That Met QC Criteria

April 25, 2024

First Posted (Actual)

April 29, 2024

Study Record Updates

Last Update Posted (Actual)

April 29, 2024

Last Update Submitted That Met QC Criteria

April 25, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DINKS01
  • DRKS00033704 (Registry Identifier: DRKS)
  • 2024-512094-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Study protocol and study report will be shared

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Urinary Incontinence

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Togo

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe