This trial aims to study the effects, costs and cost-effectiveness of an App-based program for women 18 years or older withurinary incontinence (UI) in primary care compared to care delivered by the general practitioner (GP) according to the…
ID
Source
Brief title
Condition
- Urinary tract signs and symptoms
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary outcome is the score on the International Consultation on
Incontinence Questionnaire on UI Short Form (ICIQ-UI-SF), which measures
symptoms and impact of the UI on daily life.
Secondary outcome
Secondary outcomes are the perception of improvement by the patient, number of
UI episodes, condition- specific and generic health related quality of life,
sexual functioning and costs.
Facilitators and barriers for the implementation of the intervention.
Background summary
Urinary incontinence (UI) is a highly prevalent disorder in women affecting an
estimated 25%-45% of adult women. Although effective treatments are available,
only 30% of women with UI seek help for this problem. The availability of an
easy-to-use, evidence based App for the treatment of UI may reduce the
necessity of face-to-face contacts, and increase continence rates. Especially,
the possibility to receive frequent reminders would enable patients to perform
the necessary training, as forgetting is the most important reason why
adherence can be lacking. This will help
women with UI to have a better quality of life and it will considerably reduce
health care costs.
Study objective
This trial aims to study the effects, costs and cost-effectiveness of an
App-based program for women 18 years or older with
urinary incontinence (UI) in primary care compared to care delivered by the
general practitioner (GP) according to the guideline
on UI of the Dutch college of GPs.
Study design
This is a randomized controlled trial with a non-inferiority design, and a
follow-up of four months. Women will be randomized 1:1 to one of two treatment
arms: an intervention arm in which an App will be made available to guide the
patient during the treatment phase and an arm in which patient will receive
standard care provided by their GP.
After completion of the trial phase, a subset of the study population (in both
arms, 10 women with the highest score on PGI-questionnaire, and 10 women with
the lowest scores on PGI) will enter a qualitative study on expectations and
experiences with eHealth-treatment, and on the facilitators and barriers for
the implementation of the intervention.
Study burden and risks
Not applicable.
Antonie Deusinglaan 1
Groningen 9700 AD
NL
Antonie Deusinglaan 1
Groningen 9700 AD
NL
Listed location countries
Age
Inclusion criteria
- Women, 18 years or older;
- Having access to mobile Apps on smartphone or tablet (Apple or Android platform) * wifi entrance to the internet is sufficient;
- Urinary incontinence (UI), defined as any involuntary loss of urine according to the definition of the International Consultation on Incontinence (ICI), regardless of the subtype (stress UI, urgency UI or mixed type UI). Incontinence episodes should be twice a week or more;
- Wish to be treated;
- Written informed consent.
Exclusion criteria
- Indwelling urinary catheter;
- Urogenital malignancy;
- Previous urethral surgery;
- Being treated for UI in the previous year (pharmacologically or non-pharmacologically);
- Terminally or seriously ill; according to the GP of the patient
- Cognitive impairment or psychiatric disorder;
- Urinary tract infection (dipstick and if negative, dipslide or urine culture);
- Overflow or continuous urinary incontinence;
- Pregnancy or recent childbirth (< 6 months ago);
- Inability to complete a questionnaire in Dutch.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| Other | 201400359 |
| CCMO | NL51915.042.14 |