Urinary incontinence remains a quiet crisis for millions of women. While clinical guidelines recommend pelvic floor muscle training and behavioral therapy as first-line treatments, these conservative options remain underused. Barriers like limited access to specialists, long wait times, social stigma, and poor long-term adherence often prevent patients from getting the help they need.
The DINKS trial, published in The Lancet Digital Health, looked at whether a smartphone app could help overcome these challenges. Researchers in Germany tested a multimodal digital therapeutic to determine if app-based care could match or enhance traditional clinical outcomes.
A Direct Test of Digital Intervention
The DINKS trial was a 12-week, single-blind, randomized controlled trial conducted between April and September 2024. The University Medical Center Mainz coordinated the study, recruiting 194 participants through 239 office-based urologists and gynecologists across Germany.
The researchers conducted the entire trial remotely. Eligible participants included adult women (≥18 years) suffering from stress, urge, or mixed urinary incontinence with at least one daily episode.
The study randomized participants into two groups:
- The Control Group: This group received usual care alone, with delayed app access granted only after the study ended.
- The Intervention Group: Users received Kranus Mictera, an app-based therapy providing pelvic floor training, behavioral strategies, and relaxation techniques, alongside usual care.
How the Multimodal Digital Intervention Works
Kranus Mictera operates as a digital delivery platform for multidisciplinary care rather than a simple exercise timer. The intervention includes several core therapeutic components:
- Adaptive Physiotherapy: Pelvic floor training featuring haptic feedback and customized video guides.
- Behavioral Interventions: Personalized bladder training and cognitive-behavioral tools to manage urge symptoms.
- Mental Exercises: Mindfulness and stimulus control techniques to reduce the psychological burden of the condition.
- Personalized Feedback: A digital bladder diary that offers real-time insights based on patient data.
- Clinical Integration: The app generates downloadable therapy reports that patients can share with their physicians to coordinate care.
The platform effectively replaces the need for multiple disparate providers by consolidating guideline-based treatments into one interface.
Key Results from the DINKS Trial
The researchers measured success through the relative change in daily urinary incontinence episodes and validated patient-reported outcome scales.
The data suggest that the digital therapeutic significantly enhances standard care.
| Metric | Findings from the DINKS Trial |
| Reduction in Episodes | The app group saw a 60.9% mean reduction in daily incontinence episodes, compared to just 1.7% in the control group. |
| Clinical Significance | The researchers defined a ≥50% reduction as clinically relevant. The digital group cleared this bar significantly. |
| Patient Satisfaction | Most participants in the intervention group reported being “much better” or “very much better” by the end of the study. |
| Safety | The study reported no relevant treatment-related adverse events, confirming the app as a low-risk intervention. |
Implications
The DINKS trial establishes a rigorous blueprint for how app-based interventions can integrate into standard medical practice. Rather than acting as a simple wellness tool, the study validates this multimodal therapeutic as a legitimate, guideline-based treatment pathway.
By bridging the gap between diagnosis and long-term management, these tools address the systemic bottlenecks—such as waiting lists and specialist shortages—that currently leave millions of women without effective first-line care.
Specialized care is moving out of the office and into the patient’s hands. The DINKS trial proves that digitizing pelvic health makes treatment more accessible without sacrificing clinical quality. For patients with urinary incontinence, the future of therapy is increasingly digital-first.
