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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
194
An app-based digital therapy program aimed at multimodal self-treatment for incontinence. The app is certified class I medical device (MDR).
Clinic of Urology
Mainz, Germany
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.
Time frame: 12 weeks
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)
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.
Time frame: 12 weeks
Incontinence Quality-of-Life (I-QOL)
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.
Time frame: 12 weeks
Patient Activation Measure-13 (PAM-13)
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.
Time frame: 12 weeks
Patient Global Impression of Improvement (PGI-I)
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.
Time frame: 12 weeks
Cured Patients
Proportion of patients without incontinence (cured patients) at study end
Time frame: 12 weeks
Urinary Frequency Day
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.
Time frame: 12 weeks
Urinary Frequency Night
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.
Time frame: 12 weeks
Pad Use
Change in pad use from baseline to week 12
Time frame: 12 weeks
Urge Incontinence
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.
Time frame: 12 weeks
Functional Bladder Capacity
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.
Time frame: 12 weeks
Number of Participants With Treatment Failure
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).
Time frame: 12 weeks
Stress Urinary Incontinence Episodes of the S/U-IQ
Change in stress urinary incontinence episodes of the S/U-IQ
Time frame: 12 weeks
Urgency Urinary Incontinence Episodes of the S/U-IQ
Change in urgency urinary incontinence episodes of the S/U-IQ
Time frame: 12 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.