RCT on Multimodal Self-treatment for Women with Incontinence Using a Digital Health Application
- Conditions
- Urinary Incontinence, UrgeOveractive Bladder SyndromeUrinary Incontinence,StressFemale Urinary Stress IncontinenceUrinary Incontinence
- Interventions
- Device: Kranus Mictera
- Registration Number
- NCT06389838
- Lead Sponsor
- Kranus Health GmbH
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 202
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Kranus Mictera Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care
- Primary Outcome Measures
Name Time Method Incontinence episodes 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
Name Time Method I-QoL 12 weeks Change in I-QoL from baseline to week 12; expected mean difference between groups of \> 6.3 points
PAM-13 12 weeks Change in PAM-13 questionnaire from baseline to week 12
PGI-I 12 weeks PGI-I questionnaire (overall improvement after treatment) in week 12
Cured patients 12 weeks Proportion of patients without incontinence (cured patients) at study end
ICIQ-SF 12 weeks Change (CfB) in ICIQ-SF from baseline to week 12; expected mean difference between groups of \> 2.9 points
Urinary frequency day 12 weeks Change in urinary frequency during the day from baseline to week 12
Urinary frequency night 12 weeks Change in urinary frequency at night from baseline to week 12
Pad use 12 weeks Change in pad use from baseline to week 12
Urge incontinence 12 weeks Change in urge incontinence from baseline to week 12
Functional bladder capacity 12 weeks Change in functional bladder capacity from baseline to week 12
Body weight 12 weeks Change in body weight from baseline to week 12
Treatment Failure 12 weeks Proportion of patients with treatment failure within the study period
Stress urinary incontinence episodes of the S/U-IQ 12 weeks Change in stress urinary incontinence episodes of the S/U-IQ
Urgency urinary incontinence episodes of the S/U-IQ 12 weeks Change in urgency urinary incontinence episodes of the S/U-IQ
Trial Locations
- Locations (1)
Kranus Health Gmbh
🇩🇪München, Germany