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

Not Applicable

Completed

Conditions: Urinary Incontinence, Urge
Overactive Bladder Syndrome
Urinary Incontinence,Stress
Female Urinary Stress Incontinence
Urinary Incontinence

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: 194

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)

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

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
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	12 weeks	ICIQ-SF assess the frequency and severity of urinary incontinence and its impact on the quality of life of those affected. Score range: 0 - 21 points, with higher values representing a worse outcome. Outcome measure: change in ICIQ-SF from baseline to week 12.
Incontinence Quality-of-Life (I-QOL)	12 weeks	I-QoL assesses the impact of urinary incontinence on quality of life. Scale score ranging from 0-100. Higher scores on the I-QOL indicate a better quality of life, while lower scores indicate greater impairment due to urinary incontinence. Outcome measure: change in I-QoL from baseline to week 12.
Patient Activation Measure-13 (PAM-13)	12 weeks	The PAM-13 assesses patients' self-competence and knowledge about their own health. The range is from 0 to 100 points, with higher scores for a higher level of activation. Outcome Measure: Change in PAM-13 score from baseline to week 12.
Patient Global Impression of Improvement (PGI-I)	12 weeks	The PGI-I is a subjective assessment of the improvement in state of health or symptoms. It consists of a single question that asks patients to give their own assessment of the improvement in their state of health. Scale: from "much better" to "much worse". Outcome measure: Count of participants who had an improvement ("minimally better" or higher) in PGI-I value at week 12.
Urinary Frequency Day	12 weeks	Change in urinary frequency during the day from baseline to week 12. The outcome measure was assessed via the optional app diary, so data was available only for intervention group users who utilized this feature.
Urinary Frequency Night	12 weeks	Change in urinary frequency at night from baseline to week 12. The outcome measure was assessed via the optional app diary, so data was available only for intervention group users who utilized this feature.
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. The outcome measure was assessed via the optional app diary, so data was available only for intervention group users who utilized this feature.
Functional Bladder Capacity	12 weeks	Change in functional bladder capacity from baseline to week 12. The outcome measure was assessed via the optional app diary, so data was available only for intervention group users who utilized this feature.
Number of Participants With Treatment Failure	12 weeks	Proportion of patients with treatment failure within the study period, defined as any reported worsening in the PGI-I questionnaire at the end of the study or the start of any interventions against the incontinence symptoms (conservative and invasive methods).
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
Cured Patients	12 weeks	Proportion of patients without incontinence (cured patients) at study end