RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application (NCT06389838) | Clinical Trial Compass
CompletedNot Applicable
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
Germany194 participantsStarted 2024-04-30
Plain-language 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.
Who can participate
Age range
18 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.