Clinical trial NCT06389838: RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
Official title: Prospektiv Randomisierte Studie Zur Multimodalen Selbstbehandlung Von Frauen Mit Inkontinenzbeschwerden Mit Einer Digitalen Gesundheitsanwendung
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Kranus Health GmbH
Sponsor class: INDUSTRY
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2024-04-29
Enrollment: 194
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective, randomized, controlled, single-blinded, 2-arm design
Primary purpose: TREATMENT

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.

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.

Eligibility 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
* 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)

Primary outcomes:
measure: Incontinence Episodes
timeFrame: 12 weeks
Secondary outcomes:
measure: International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
timeFrame: 12 weeks
measure: Incontinence Quality-of-Life (I-QOL)
timeFrame: 12 weeks
measure: Patient Activation Measure-13 (PAM-13)
timeFrame: 12 weeks
measure: Patient Global Impression of Improvement (PGI-I)
timeFrame: 12 weeks
measure: Cured Patients
timeFrame: 12 weeks
measure: Urinary Frequency Day
timeFrame: 12 weeks
measure: Urinary Frequency Night
timeFrame: 12 weeks
measure: Pad Use
timeFrame: 12 weeks
measure: Urge Incontinence
timeFrame: 12 weeks
measure: Functional Bladder Capacity
timeFrame: 12 weeks
measure: Number of Participants With Treatment Failure
timeFrame: 12 weeks
measure: Stress Urinary Incontinence Episodes of the S/U-IQ
timeFrame: 12 weeks
measure: Urgency Urinary Incontinence Episodes of the S/U-IQ
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Mainz
country: Germany
facility: Clinic of Urology
Study officials:
affiliation: Director of the Clinic of Urology, University of Mainz , Germyny
name: Axel Haferkamp, PhD
role: PRINCIPAL_INVESTIGATOR
References: