N/A
N=194
RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application
Urinary Incontinence,Stress · Urinary Incontinence, Urge · Urinary Incontinence · Overactive Bladder Syndrome · Female Urinary Stress Incontinence
Bottom Line
View on ClinicalTrials.gov: NCT06389838 ↗Enrolled (actual)
194
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Incontinence Episodes — -2.25; -0.14 number of incontinencies
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Kranus Mictera (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Kranus Health GmbH
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incontinence Episodes |
-2.25; -0.14 | — |
| SECONDARY International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) |
-3.94; -0.27 | — |
| SECONDARY Incontinence Quality-of-Life (I-QOL) |
17.9; 1.16 | — |
| SECONDARY Patient Activation Measure-13 (PAM-13) |
7.35; 0.51 | — |
| SECONDARY Patient Global Impression of Improvement (PGI-I) |
84; 11 | — |
| SECONDARY Cured Patients |
22; 2 | — |
| SECONDARY Urinary Frequency in OAB/ Mixed Group |
-2.65 | — |
| SECONDARY Urinary Frequency Night |
-0.29 | — |
| SECONDARY Pad Use |
-2.63; 0.15 | — |
| SECONDARY Urge Incontinence |
-0.84 | — |
| SECONDARY Functional Bladder Capacity |
48.28 | — |
| SECONDARY Number of Participants With Treatment Failure |
4; 20 | — |
| SECONDARY Stress Urinary Incontinence Episodes of the S/U-IQ |
-10.14; -0.59 | — |
| SECONDARY Urgency Urinary Incontinence Episodes of the S/U-IQ |
-1.53; 0.67 | — |
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.
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 35)
- Recurrent urinary tract infections (at least 2 within 6 months or 3 within a year)
Data sourced from ClinicalTrials.gov (NCT06389838). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.