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Urinary Incontinence,StressDINKSNCT06389838

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

A study testing Kranus Mictera in people with Urinary Incontinence,Stress and Urinary Incontinence, Urge, run by Kranus Health GmbH at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Kranus Mictera
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
194 participants
Where
1 siteGermany
Study dates
30 Apr 2024to 6 Dec 2024
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 16Show fewer
  • 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)

Trial locations and contacts

1 site in 1 country.

Germany1 site

  • Clinic of Urology

    Mainz, Germany, 55131

Other trials in Germany

About this study

Official title: Prospektiv Randomisierte Studie Zur Multimodalen Selbstbehandlung Von Frauen Mit Inkontinenzbeschwerden Mit Einer Digitalen Gesundheitsanwendung

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.

Read the 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.

Being tested
Kranus Mictera
Keywords
Urinary Incontinence, Mobile Health, Digital therapeutics, Pelvic Floor exercises, bladder control, digital health, app based therapy, behavioral intervention, quality of life
Medical subject headings
Urinary Incontinence, Stress, Urinary Incontinence, Urge, Urinary Incontinence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Kranus MicteraDevice

    An app-based digital therapy program aimed at multimodal self-treatment for incontinence. The app is certified class I medical device (MDR).

Study groups in NCT06389838
Study groupRoleWhat they receive
InterventionExperimentalIntervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care
Receives: Device: Kranus Mictera
ControlNo interventionParticipants will continue with their therapy treatment (standard of care) if they are on it for more that four weeks before inclusion. Beginning of new therapies during the study is not allowed.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 12 weeks

Secondary outcomes (13)

  1. 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.

    Measured: 12 weeks

  2. 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.

    Measured: 12 weeks

  3. 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.

    Measured: 12 weeks

  4. 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.

    Measured: 12 weeks

  5. Cured Patients

    Proportion of patients without incontinence (cured patients) at study end

    Measured: 12 weeks

  6. Urinary Frequency in OAB/ Mixed Group

    Change in urinary frequency 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.

    Measured: 12 weeks

  7. 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.

    Measured: 12 weeks

  8. Pad Use

    Change in pad use from baseline to week 12

    Measured: 12 weeks

  9. 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.

    Measured: 12 weeks

  10. 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.

    Measured: 12 weeks

  11. 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).

    Measured: 12 weeks

  12. Stress Urinary Incontinence Episodes of the S/U-IQ

    Change in stress urinary incontinence episodes of the S/U-IQ

    Measured: 12 weeks

  13. Urgency Urinary Incontinence Episodes of the S/U-IQ

    Change in urgency urinary incontinence episodes of the S/U-IQ

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Apr 2024
  2. Study start30 Apr 2024
  3. Primary completion6 Dec 2024
  4. Study completion6 Dec 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Prospective, randomized, controlled, single-blinded, 2-arm design
Masking
Single blind
Who is masked
Investigator
Enrolment
194 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06389838
Sponsor's protocol ID
DINKS01
Other IDs
DRKS00033704, 2024-512094-27
Acronym
DINKS
Status last verified
Apr 2026
First submitted
25 Apr 2024
Last updated
28 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Study protocol and study report will be shared

Publications

  • Haferkamp A, Frey L, Duwe G, Borner JH, Hunfeld C, Brocker KA, Troilo S, Lehmacher W, Papp CP, Miller K, Wiemer L. App-based therapy for female patients with urinary incontinence in Germany (DINKS): a single-blind, randomised, controlled trial. Lancet Digit Health. 2025 Dec;7(12):100935. doi: 10.1016/j.landig.2025.100935. Epub 2025 Dec 16.

    PubMed 41407582

Questions about this trial

What is this clinical trial studying?

A study testing Kranus Mictera in people with Urinary Incontinence,Stress and Urinary Incontinence, Urge, run by Kranus Health GmbH at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 13 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incontinence Episodes (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06389838, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2026.

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