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

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ClinicalTrials.gov Identifier: NCT06389838
Recruitment Status : Not yet recruiting
First Posted : April 29, 2024
Last Update Posted : April 29, 2024
Sponsor:
Collaborator:
Johannes Gutenberg University Mainz
Information provided by (Responsible Party):
Kranus Health GmbH

Study Description
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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.

Condition or disease Intervention/treatment Phase
Urinary Incontinence,Stress Urinary Incontinence, Urge Urinary Incontinence Overactive Bladder Syndrome Female Urinary Stress Incontinence Device: Kranus Mictera Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, controlled, single-blinded, 2-arm design
Masking: Single (Investigator)
Masking Description: Participants know which group they are assigned to, but the investigators are blinded.
Primary Purpose: Treatment
Official Title: Prospektiv Randomisierte Studie Zur Multimodalen Selbstbehandlung Von Frauen Mit Inkontinenzbeschwerden Mit Einer Digitalen Gesundheitsanwendung
Estimated Study Start Date : April 29, 2024
Estimated Primary Completion Date : September 30, 2024
Estimated Study Completion Date : December 1, 2024
Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. I-QoL [ Time Frame: 12 weeks ]
    Change in I-QoL from baseline to week 12; expected mean difference between groups of > 6.3 points

  3. PAM-13 [ Time Frame: 12 weeks ]
    Change in PAM-13 questionnaire from baseline to week 12

  4. PGI-I [ Time Frame: 12 weeks ]
    PGI-I questionnaire (overall improvement after treatment) in week 12

  5. Cured patients [ Time Frame: 12 weeks ]
    Proportion of patients without incontinence (cured patients) at study end

  6. Urinary frequency day [ Time Frame: 12 weeks ]
    Change in urinary frequency during the day from baseline to week 12

  7. Urinary frequency night [ Time Frame: 12 weeks ]
    Change in urinary frequency at night from baseline to week 12

  8. Pad use [ Time Frame: 12 weeks ]
    Change in pad use from baseline to week 12

  9. Urge incontinence [ Time Frame: 12 weeks ]
    Change in urge incontinence from baseline to week 12

  10. Functional bladder capacity [ Time Frame: 12 weeks ]
    Change in functional bladder capacity from baseline to week 12

  11. Body weight [ Time Frame: 12 weeks ]
    Change in body weight from baseline to week 12

  12. Treatment Failure [ Time Frame: 12 weeks ]
    Proportion of patients with treatment failure within the study period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06389838


Locations
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Germany
Kranus Health Gmbh
München, Germany, 80331
Contact: Laura E Wiemer, MD    +4989 124 146 79    lwiemer@kranushelath.com   
Sponsors and Collaborators
Kranus Health GmbH
Johannes Gutenberg University Mainz
More Information
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Additional Information:

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Responsible Party: Kranus Health GmbH
ClinicalTrials.gov Identifier: NCT06389838    
Other Study ID Numbers: DINKS01
DRKS00033704 ( Registry Identifier: DRKS )
2024-512094-27 ( EudraCT Number )
First Posted: April 29, 2024    Key Record Dates
Last Update Posted: April 29, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Study protocol and study report will be shared

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kranus Health GmbH:
Urinary Incontinence
Mobile Health
Digital therapeutics
Pelvic Floor exercises
bladder control
 digital health
app based therapy
behavioral intervention
quality of life
Additional relevant MeSH terms:
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Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Stress
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
 Urogenital Diseases
Male Urogenital Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases