to investigate barriers and facilitators of implementation of an e-health intervention for the treatment and guidance of Dutch women with SUI, as well as its effect on incontinence severity and quality of life.
ID
Source
Brief title
Condition
- Other condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Health condition
Stressincontinentie voor urine
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main endpoint will be the barriers en facilitators for implementation of an
e-health intervention for Dutch women with SUI. This endpoint will be examined
from different perspectives: including the perspective of the participants of
the e-health intervention and the general practitioners who potentially could
refer to the e-health intervention.
Secondary outcome
- Effect of eHealth intervention on incontinence severity
- Effect of eHealth intervention on quality of life
- Baseline and follow-up factors that are associated with successful treatment
will be investigated
- The potential of eHealth to stimulate help seeking behaviour will be
investigated.
Background summary
Stress urinary incontinence (SUI) is a common problem with great potential
influence on quality of life. Although effective treatment options are
available, women do not always seek help. Internet delivery may make healthcare
more accessible to women with SUI. An e-health intervention for SUI has shown
to be effective in a Swedish trial. Based on these results, implementation of
an e-health intervention for Dutch women with SUI might be successful.
Study objective
to investigate barriers and facilitators of implementation of an e-health
intervention for the treatment and guidance of Dutch women with SUI, as well as
its effect on incontinence severity and quality of life.
Study design
observational study with pre- and post-test.
Intervention
e-health intervention for SUI based on the principles of pelvic floor muscle
treatment and life style advices guided by e-mail.
Study burden and risks
Women participating in the study will have to complete self-report
questionnaires at baseline, during the intervention, immediately after
treatment completion (3 months after baseline), and six months after baseline.
Non-adherers will be approached by email and asked about their reasons for
non-completion and their suggestions for improvement of the e-health
intervention. Participants who do not complete and return the questionnaire
within one week will be send a reminder by e-mail. After completion of the
intervention, a subset of participants (+/- 30) will be asked to participate in
semi structured interviews. Also +/- 15 general practitioners will be asked to
participate in semi-structured interviews. There are no risks associated with
participation in this trial.
Geert Grooteplein 21
Nijmegen 6500 HB
NL
Geert Grooteplein 21
Nijmegen 6500 HB
NL
Listed location countries
Age
Inclusion criteria
- Women aged * 18 years;
- Stress urinary incontinence;
- Capable of understanding Dutch language;
- Internet access
Exclusion criteria
- Participation in another therapy program/ trial regarding stress urinary incontinence
- Surgery for urinary incontinence six months prior to baseline
- Pelvic floor muscle treatment from physiotherapist six months prior to baseline
- Pregnancy
- Vaginal delivery 6 months prior to baseline
- Neurological disease affecting lower limbs (Parkinson, Multiple Sclerosis, Cerebrovascular accident)
- Malignancy in lower abdomen currently or in the past 5 years (colon, uterus, vagina, cervix, bladder or ovary)
Design
Recruitment
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 |
|---|---|
| ClinicalTrials.gov | NCT6956 |
| CCMO | NL58716.091.16 |