Female Urinary Stress Incontinence, Overactive Bladder Syndrome, Urinary Incontinence, Urinary Incontinence,Stress, Urinary Incontinence, Urge
Conditions
Keywords
Urinary Incontinence, Mobile Health, Digital therapeutics, Pelvic Floor exercises, bladder control, digital health, app based therapy, behavioral intervention, quality of life
Brief 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.
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.
Interventions
DEVICEKranus Mictera
An app-based digital therapy program aimed at multimodal self-treatment for incontinence. The app is certified class I medical device (MDR).
Sponsors
Kranus Health GmbH
Johannes Gutenberg University Mainz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Masking description
Participants know which group they are assigned to, but the investigators are blinded.
Intervention model description
Prospective, randomized, controlled, single-blinded, 2-arm design
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incontinence Episodes | 12 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | 12 weeks | 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. |
| Incontinence Quality-of-Life (I-QOL) | 12 weeks | 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. |
| Patient Activation Measure-13 (PAM-13) | 12 weeks | 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. |
| Patient Global Impression of Improvement (PGI-I) | 12 weeks | 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. |
| Cured Patients | 12 weeks | Proportion of patients without incontinence (cured patients) at study end |
| Urinary Frequency in OAB/ Mixed Group | 12 weeks | 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. |
| Urinary Frequency Night | 12 weeks | 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. |
| Pad Use | 12 weeks | Change in pad use from baseline to week 12 |
| Urge Incontinence | 12 weeks | 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. |
| Functional Bladder Capacity | 12 weeks | 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. |
| Number of Participants With Treatment Failure | 12 weeks | 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). |
| Stress Urinary Incontinence Episodes of the S/U-IQ | 12 weeks | Change in stress urinary incontinence episodes of the S/U-IQ |
| Urgency Urinary Incontinence Episodes of the S/U-IQ | 12 weeks | Change in urgency urinary incontinence episodes of the S/U-IQ |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORAxel Haferkamp, PhD
Director of the Clinic of Urology, University of Mainz , Germyny
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care | 96 |
| Control Participants 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. | 98 |
| Total | 194 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 48.5 years STANDARD_DEVIATION 11.65 | 50.0 years STANDARD_DEVIATION 11.8 | 51.0 years STANDARD_DEVIATION 12.01 |
| BMI | 25.04 kg/m2 STANDARD_DEVIATION 4.11 | 25.37 kg/m2 STANDARD_DEVIATION 4.24 | 25.69 kg/m2 STANDARD_DEVIATION 4.47 |
| Country of birth Germany | 82 Participants | 170 Participants | 88 Participants |
| Country of birth Kyrgyzstan | 2 Participants | 2 Participants | 0 Participants |
| Country of birth Others | 8 Participants | 14 Participants | 6 Participants |
| Country of birth Russian Federation | 3 Participants | 6 Participants | 3 Participants |
| Country of birth United Kingdom | 1 Participants | 2 Participants | 1 Participants |
| Duration of incontinence | 5.31 year STANDARD_DEVIATION 6 | 5.26 year STANDARD_DEVIATION 5.76 | 5.21 year STANDARD_DEVIATION 5.55 |
| Number of incontinence episodes per 24h | 3.71 episodes STANDARD_DEVIATION 2.32 | 3.64 episodes STANDARD_DEVIATION 2.2 | 3.57 episodes STANDARD_DEVIATION 2.09 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Germany | 96 Participants | 194 Participants | 98 Participants |
| Sex: Female, Male Female | 96 Participants | 194 Participants | 98 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
| Type of incontinence Mixed incontinence | 15 Participants | 30 Participants | 15 Participants |
| Type of incontinence Stress incontinence | 60 Participants | 121 Participants | 61 Participants |
| Type of incontinence Urge incontinence | 21 Participants | 43 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 96 | 0 / 98 |
| other Total, other adverse events | 0 / 96 | 0 / 98 |
| serious Total, serious adverse events | 0 / 96 | 0 / 98 |
Outcome results
Primary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Incontinence Episodes | -2.25 number of incontinencies | Standard Deviation 2.26 |
| Control | Incontinence Episodes | -0.14 number of incontinencies | Standard Deviation 1.45 |
Secondary
Cured Patients
Proportion of patients without incontinence (cured patients) at study end
Time frame: 12 weeks
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Cured Patients | 22 Participants |
| Control | Cured Patients | 2 Participants |
Secondary
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
Population: Data was available only for intervention group users who utilized this feature, leaving the control group without corresponding data. Entry was optional for the participants using the app. Therefore, there is a lower number of participant for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Functional Bladder Capacity | 48.28 ml | Standard Deviation 57.48 |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Incontinence Quality-of-Life (I-QOL) | 17.9 scores on a scale |
| Control | Incontinence Quality-of-Life (I-QOL) | 1.16 scores on a scale |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | -3.94 scores on a scale |
| Control | International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF) | -0.27 scores on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Number of Participants With Treatment Failure | 4 Participants |
| Control | Number of Participants With Treatment Failure | 20 Participants |
Secondary
Pad Use
Change in pad use from baseline to week 12
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Pad Use | -2.63 pads | Standard Deviation 4.37 |
| Control | Pad Use | 0.15 pads | Standard Deviation 3.5 |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Intervention | Patient Activation Measure-13 (PAM-13) | 7.35 scores on a scale |
| Control | Patient Activation Measure-13 (PAM-13) | 0.51 scores on a scale |
Secondary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Patient Global Impression of Improvement (PGI-I) | 84 Participants |
| Control | Patient Global Impression of Improvement (PGI-I) | 11 Participants |
Secondary
Stress Urinary Incontinence Episodes of the S/U-IQ
Change in stress urinary incontinence episodes of the S/U-IQ
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Stress Urinary Incontinence Episodes of the S/U-IQ | -10.14 episodes | Standard Deviation 14.69 |
| Control | Stress Urinary Incontinence Episodes of the S/U-IQ | -0.59 episodes | Standard Deviation 12.94 |
Secondary
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
Population: Data was available only for intervention group users who utilized this feature, leaving the control group without corresponding data. Entry was optional for the participants using the app. Therefore, there is a lower number of participant for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Urge Incontinence | -0.84 episodes | Standard Deviation 1.82 |
Secondary
Urgency Urinary Incontinence Episodes of the S/U-IQ
Change in urgency urinary incontinence episodes of the S/U-IQ
Time frame: 12 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Urgency Urinary Incontinence Episodes of the S/U-IQ | -1.53 eisodes | Standard Deviation 11.13 |
| Control | Urgency Urinary Incontinence Episodes of the S/U-IQ | 0.67 eisodes | Standard Deviation 7.89 |
Secondary
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
Population: Data was available only for intervention group users who utilized this feature, leaving the control group without corresponding data. Entry was optional for the participants using the app. Therefore, there is a lower number of participant for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Urinary Frequency Day | -1.51 urination events per day | Standard Deviation 2.28 |
Secondary
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
Population: Data was available only for intervention group users who utilized this feature, leaving the control group without corresponding data. Entry was optional for the participants using the app. Therefore, there is a lower number of participant for this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention | Urinary Frequency Night | -0.29 urination events per night | Standard Deviation 0.62 |