Trial Outcomes & Findings for RCT on Multimodal Self-treatment for Women With Incontinence Using a Digital Health Application (NCT NCT06389838)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

194 participants

Primary outcome timeframe

12 weeks

Results posted on

2026-04-28

Participant Flow

Participant milestones

Participant milestones
Measure	Intervention Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control Participants will continue their therapy treatment (standard of care) if they are on it for more than four weeks before inclusion.
Overall Study STARTED	96	98
Overall Study COMPLETED	92	94
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.	Total n=194 Participants Total of all reporting groups
Duration of incontinence	5.31 year STANDARD_DEVIATION 6 • n=96 Participants	5.21 year STANDARD_DEVIATION 5.55 • n=98 Participants	5.26 year STANDARD_DEVIATION 5.76 • n=194 Participants
Age, Continuous	48.5 years STANDARD_DEVIATION 11.65 • n=96 Participants	51.0 years STANDARD_DEVIATION 12.01 • n=98 Participants	50.0 years STANDARD_DEVIATION 11.80 • n=194 Participants
Sex: Female, Male Female	96 Participants n=96 Participants	98 Participants n=98 Participants	194 Participants n=194 Participants
Sex: Female, Male Male	0 Participants n=96 Participants	0 Participants n=98 Participants	0 Participants n=194 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment Germany	96 Participants n=96 Participants	98 Participants n=98 Participants	194 Participants n=194 Participants
BMI	25.04 kg/m2 STANDARD_DEVIATION 4.11 • n=96 Participants	25.69 kg/m2 STANDARD_DEVIATION 4.47 • n=98 Participants	25.37 kg/m2 STANDARD_DEVIATION 4.24 • n=194 Participants
Type of incontinence Stress incontinence	60 Participants n=96 Participants • Proportion of participants with either stress, urge and mixed incontinence.	61 Participants n=98 Participants • Proportion of participants with either stress, urge and mixed incontinence.	121 Participants n=194 Participants • Proportion of participants with either stress, urge and mixed incontinence.
Type of incontinence Urge incontinence	21 Participants n=96 Participants • Proportion of participants with either stress, urge and mixed incontinence.	22 Participants n=98 Participants • Proportion of participants with either stress, urge and mixed incontinence.	43 Participants n=194 Participants • Proportion of participants with either stress, urge and mixed incontinence.
Type of incontinence Mixed incontinence	15 Participants n=96 Participants • Proportion of participants with either stress, urge and mixed incontinence.	15 Participants n=98 Participants • Proportion of participants with either stress, urge and mixed incontinence.	30 Participants n=194 Participants • Proportion of participants with either stress, urge and mixed incontinence.
Number of incontinence episodes per 24h	3.71 episodes STANDARD_DEVIATION 2.32 • n=96 Participants	3.57 episodes STANDARD_DEVIATION 2.09 • n=98 Participants	3.64 episodes STANDARD_DEVIATION 2.2 • n=194 Participants
Country of birth Germany	82 Participants n=96 Participants	88 Participants n=98 Participants	170 Participants n=194 Participants
Country of birth Russian Federation	3 Participants n=96 Participants	3 Participants n=98 Participants	6 Participants n=194 Participants
Country of birth United Kingdom	1 Participants n=96 Participants	1 Participants n=98 Participants	2 Participants n=194 Participants
Country of birth Kyrgyzstan	2 Participants n=96 Participants	0 Participants n=98 Participants	2 Participants n=194 Participants
Country of birth Others	8 Participants n=96 Participants	6 Participants n=98 Participants	14 Participants n=194 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Incontinence Episodes	-2.25 number of incontinencies Standard Deviation 2.26	-0.14 number of incontinencies Standard Deviation 1.45

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
International Consultation on Incontinence Questionnaire - Short Form (ICIQ-SF)	-3.94 scores on a scale Interval -12.0 to 3.0	-0.27 scores on a scale Interval -7.0 to 4.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Incontinence Quality-of-Life (I-QOL)	17.9 scores on a scale Interval -24.0 to 65.0	1.16 scores on a scale Interval -30.0 to 27.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Patient Activation Measure-13 (PAM-13)	7.35 scores on a scale Interval -73.0 to 58.0	0.51 scores on a scale Interval -14.0 to 43.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Intervention n=92 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=94 Participants 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.
Patient Global Impression of Improvement (PGI-I)	84 Participants	11 Participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Cured Patients	22 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=66 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	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.
Urinary Frequency in OAB/ Mixed Group	-2.65 urination events per day Standard Deviation 2.36	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=39 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	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.
Urinary Frequency Night	-0.29 urination events per night Standard Deviation 0.62	—

SECONDARY outcome

Timeframe: 12 weeks

Change in pad use from baseline to week 12

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Pad Use	-2.63 pads Standard Deviation 4.37	0.15 pads Standard Deviation 3.50

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=14 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	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.
Urge Incontinence	-0.84 episodes Standard Deviation 1.82	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Intervention n=66 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	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.
Functional Bladder Capacity	48.28 ml Standard Deviation 57.48	—

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Number of Participants With Treatment Failure	4 Participants	20 Participants

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Stress Urinary Incontinence Episodes of the S/U-IQ	-10.14 episodes Standard Deviation 14.69	-0.59 episodes Standard Deviation 12.94

SECONDARY outcome

Timeframe: 12 weeks

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

Outcome measures

Outcome measures
Measure	Intervention n=96 Participants Intervention through a digital therapy program aimed at multimodal self-treatment for incontinence in addition to standard of care	Control n=98 Participants 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.
Urgency Urinary Incontinence Episodes of the S/U-IQ	-1.53 eisodes Standard Deviation 11.13	0.67 eisodes Standard Deviation 7.89

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Trials

Kranus Health GmbH

Phone: +491756939818

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place