Trial Outcomes & Findings for Mobile App-treatment of Mixed and Urgency Urinary Incontinence in Women (NCT NCT03097549)

NCT ID: NCT03097549

Last Updated: 2025-02-19

Results Overview

Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 142 participants
• Primary outcome timeframe: 15 weeks
• Results posted on: 2025-02-19

Participant Flow

After enrollment, each respondent was contacted via telephone by a specialist incontinence nurse or general practitioner. A telephone interview was conducted with the objectives of confirming the symptom diagnosis (ie, UUI or MUI), reconfirming the absence of exclusion criteria, and ensuring that the participant was fully informed about the study. Of the 142 enrolled,19 participants were found ineligible at the telephone interview.

Participant milestones

Measure	Tät®II Treatment App Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Overall Study STARTED	60	63
Overall Study COMPLETED	58	63
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Measure	Tät®II Treatment App Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	1	0

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Tät®II Treatment App n=60 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.	Total n=123 Participants Total of all reporting groups
Age, Continuous	58.9 years STANDARD_DEVIATION 9.2 • n=60 Participants	57.7 years STANDARD_DEVIATION 9.9 • n=63 Participants	58.3 years STANDARD_DEVIATION 9.6 • n=123 Participants
Sex: Female, Male Female	60 Participants n=60 Participants	63 Participants n=63 Participants	123 Participants n=123 Participants
Sex: Female, Male Male	0 Participants n=60 Participants	0 Participants n=63 Participants	0 Participants n=123 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
BMI	26.5 kg/m2 STANDARD_DEVIATION 3.6 • n=60 Participants	25.9 kg/m2 STANDARD_DEVIATION 5.2 • n=63 Participants	26.2 kg/m2 STANDARD_DEVIATION 4.5 • n=123 Participants
University education >=3 years, n (%)	44 Participants n=60 Participants	35 Participants n=63 Participants	79 Participants n=123 Participants
Self-rated knowledge in using computers or tablets (1-4 points)	3.5 units on a scale STANDARD_DEVIATION 0.6 • n=60 Participants	3.4 units on a scale STANDARD_DEVIATION 0.6 • n=63 Participants	3.4 units on a scale STANDARD_DEVIATION 0.6 • n=123 Participants
eHEALS score	32.85 units on a scale STANDARD_DEVIATION 5.59 • n=60 Participants	33.83 units on a scale STANDARD_DEVIATION 4.51 • n=63 Participants	33.35 units on a scale STANDARD_DEVIATION 5.07 • n=123 Participants
Physical activity >3 hours/week	33 Participants n=60 Participants	40 Participants n=63 Participants	73 Participants n=123 Participants
Smoker	1 Participants n=60 Participants	2 Participants n=63 Participants	3 Participants n=123 Participants
Coffee consumption >= 5 cups/day	7 Participants n=60 Participants	10 Participants n=63 Participants	17 Participants n=123 Participants
Tea consumption >= 5 cups/day	4 Participants n=60 Participants	2 Participants n=63 Participants	6 Participants n=123 Participants
Often or always constipated	6 Participants n=60 Participants	3 Participants n=63 Participants	9 Participants n=123 Participants
Never given birth	8 Participants n=60 Participants	7 Participants n=63 Participants	15 Participants n=123 Participants
Postmenopausal >1 year	42 Participants n=60 Participants	47 Participants n=63 Participants	89 Participants n=123 Participants
Local estrogen usage	11 Participants n=60 Participants	13 Participants n=63 Participants	24 Participants n=123 Participants
Systemic estrogen usage	1 Participants n=60 Participants	1 Participants n=63 Participants	2 Participants n=123 Participants
Hysterectomy	4 Participants n=60 Participants	7 Participants n=63 Participants	11 Participants n=123 Participants
Prolapse surgery	3 Participants n=60 Participants	0 Participants n=63 Participants	3 Participants n=123 Participants
Incontinence surgery	3 Participants n=60 Participants	3 Participants n=63 Participants	6 Participants n=123 Participants
Mixed urinary incontinence	45 Participants n=60 Participants	43 Participants n=63 Participants	88 Participants n=123 Participants
Urgency urinary incontinence	15 Participants n=60 Participants	20 Participants n=63 Participants	35 Participants n=123 Participants
Duration of urinary incontinence symptoms >5 years	37 Participants n=60 Participants	38 Participants n=63 Participants	75 Participants n=123 Participants
Previous health care contact for incontinence symptoms	19 Participants n=60 Participants	19 Participants n=63 Participants	38 Participants n=123 Participants
ICIQ-UI SF score	11.71 units on a scale STANDARD_DEVIATION 3.48 • n=60 Participants	11.44 units on a scale STANDARD_DEVIATION 3.20 • n=63 Participants	11.58 units on a scale STANDARD_DEVIATION 3.33 • n=123 Participants
IEF per week	21.82 urinary leakage episodes/week STANDARD_DEVIATION 16.80 • n=60 Participants	21.06 urinary leakage episodes/week STANDARD_DEVIATION 13.71 • n=63 Participants	21.43 urinary leakage episodes/week STANDARD_DEVIATION 15.23 • n=123 Participants

PRIMARY outcome

Timeframe: 15 weeks

Three items on frequency, amount of leakage and overall impact. Scoring 0-21, higher values indicating increasing severity.

Outcome measures

Measure	Tät®II Treatment App n=58 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
International Consultation on Incontinence Modular Questionnaire Urinary Incontinence Short Form (ICIQ-UI SF)	7.0 score on a scale Standard Deviation 3.7	9.8 score on a scale Standard Deviation 3.5

SECONDARY outcome

Timeframe: 15 weeks

The instrument includes 19 items on the impact of the leakage. All items are scored 1-4 (not at all/never, slightly/sometimes, moderately/often, a lot/all the time). The overall score is 19-76, with higher values indicating increased impact on QOL.

Outcome measures

Measure	Tät®II Treatment App n=58 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
International Consultation on Incontinence Modular Questionnaire Lower Urinary Tract Symptoms Quality of Life (ICIQ- LUTSqol).	29.8 score on a scale Standard Deviation 7.8	36.5 score on a scale Standard Deviation 9.0

SECONDARY outcome

Timeframe: 15 weeks

Number of incontinence episodes per 48 hours transferred to per week.

Outcome measures

Measure	Tät®II Treatment App n=60 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Change From Baseline Incontinence Episode Frequency (IEF)	3.5 urinary leakage episodes/week Interval 0.0 to 10.5	10.5 urinary leakage episodes/week Interval 7.0 to 21.0

SECONDARY outcome

Timeframe: 15 weeks

Four items on frequency of micturition during day and during night, frequency of urgency and urgency leakage, each item scored 0-4, total score 0-16, higher values indicating increased severity.

Outcome measures

Measure	Tät®II Treatment App n=58 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
International Consultation on Incontinence Modular Questionnaire Overactive Bladder (ICIQ-OAB)	4.7 score on a scale Standard Deviation 2.0	6.4 score on a scale Standard Deviation 2.0

SECONDARY outcome

Timeframe: 15 weeks

Seven items on fear of leakage and urgency. Alternatives on each item; Never (=0), sometimes (=1), often (=2), Always (=3). Score 0-21.

Outcome measures

Measure	Tät®II Treatment App n=58 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Incontinence Catastrophizing Scale (ICS)	2.3 score on a scale Standard Deviation 2.1	4.1 score on a scale Standard Deviation 2.5

SECONDARY outcome

Timeframe: 15 weeks

Use of incontinence aids during the last four weeks, six response options from "Never" to "more than one incontinence aid per day"

Outcome measures

Measure	Tät®II Treatment App n=58 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Change From Baseline Usage of Incontinence Aids at 15 Weeks Less than once a week	38 Participants	25 Participants
Change From Baseline Usage of Incontinence Aids at 15 Weeks Once a week or more	20 Participants	38 Participants

SECONDARY outcome

Timeframe: 15 weeks

Population: Missing values for two participants in the treatment group were imputed as "no change".

Validated 7-item scale on improvement from very much improved to very much worse.

Outcome measures

Measure	Tät®II Treatment App n=60 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 Participants Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Patient Global Impression of Improvement (PGI-I) Any improvement	52 Participants	19 Participants
Patient Global Impression of Improvement (PGI-I) No change, or worsened condition	8 Participants	44 Participants

SECONDARY outcome

Timeframe: 15 weeks, only for the Tät® II treatment app group

Population: Missing values for 5 participants.

A self-rated question about if the current treatment was sufficient, with three response options.

Outcome measures

Measure	Tät®II Treatment App n=55 Participants Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Patient Satisfaction Satisfied with the treatment	35 Participants	—
Patient Satisfaction Not satisfied, but not considering seeking additional care	13 Participants	—
Patient Satisfaction Not satisfied, and considering seeking additional care	7 Participants	—

Adverse Events

Tät®II Treatment App

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Tät®II Information App

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Tät®II Treatment App n=60 participants at risk Comprehensive treatment programme with information and exercises. Tailored advice. Tät®II Treatment app: Information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Information about psychological factors and life style factors that might interfere with incontinence .Exercises for the pelvic floor muscles, for bladder training, and for behaviours of avoidance due to fear of leakage, a statistic function and possibility to set reminders. Automated feedback. Tailored advice regarding life style factors and training based on findings from the bladder diary and answers in the questionnaires.	Tät®II Information App n=63 participants at risk Information only. . Tät®II Information app: Brief information about pelvic floor muscle training and bladder training for urgency and mixed urinary incontinence. Brief information about psychological factors and life style factors that might interfere with incontinence.
Musculoskeletal and connective tissue disorders Inguinal hernia	1.7% 1/60 • Number of events 1 • Treatment app group:15 weeks from randomisation. Information app group: 15 weeks from randomisation Participants were informed to contact the study team in case of any adverse events during the study via e-mail or via telephone.	0.00% 0/63 • Treatment app group:15 weeks from randomisation. Information app group: 15 weeks from randomisation Participants were informed to contact the study team in case of any adverse events during the study via e-mail or via telephone.
Renal and urinary disorders Altered incontinence symptoms	1.7% 1/60 • Number of events 1 • Treatment app group:15 weeks from randomisation. Information app group: 15 weeks from randomisation Participants were informed to contact the study team in case of any adverse events during the study via e-mail or via telephone.	0.00% 0/63 • Treatment app group:15 weeks from randomisation. Information app group: 15 weeks from randomisation Participants were informed to contact the study team in case of any adverse events during the study via e-mail or via telephone.

Additional Information

Towe Wadensten

Umeå University

Phone: 0046907865000

Email: towe.wadensten@umu.se

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place