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

Urinary Incontinence Clinical Trial

— DINKS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06389838
• Other study ID #: DINKS01
• Secondary ID: DRKS000337042024
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: June 2024
• Source: Kranus Health GmbH
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: December 1, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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).

Locations

Country	Name	City	State
Germany	Kranus Health Gmbh	München

Sponsors (2)

Lead Sponsor	Collaborator
Kranus Health GmbH	Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

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

External Links

•   Kranus webpage for the medical device