stress-urine-incontinentie involuntary loss of urine stress urinary incontinence
Conditions
Interventions
Holistic self-support system including:
1. Pelvic floor muscle training
2. Portable vaginal biofeedback device
3. Application for smartphone / tablet including serious games, intended to
facilitate
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: - Women between 18 and 75 years old - Symptoms of mild or moderate stress urinary incontinence
Exclusion criteria
Exclusion criteria: 1. Mixed urinary incontinence (MUI) with a predominance of urge urinary incontinence. 2. Subjects who are not able to give informed consent, due to legal incapability or history or current major psychiatric illness (as subjectively assessed by a physician). 3. Subjects who are pregnant 4. Subjects who underwent specialized pelvic floor muscle therapy (PFMT) for urinary incontinence in the previous 12 months 5. Subjects with genital prolapse beyond the hymen (Baden-Walker grade 3 or 4). prolapse stage 2 or more according to the POP-Q classification. 6. History of recurrent lower urinary tract infection (>4 times/year) 7. Insufficient knowledge or understanding of the Dutch / Spanish / Finnish language 8. Insufficient score on the IT-knowledge questionnaire 9. Woman unable to contract her pelvic floor muscles (Oxford = 0) 10. History of chronic neurological condition, like spinal cord injury, multiple sclerosis, cerebro-vascular incidents.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Subjective improvement of SUI symptoms | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Objective cure of SUI symptoms 2. Incontinence related quality of life 3. Generic quality of life 4. Indication for SUI-surgery during follow-up 5. Patient satisfaction 6. Costs 7. Performance of pelvic floor 8. Adherence to treatment 9. Treatment-related adverse events 10. Serious Adverse Device Events (SADE*s) | — |
Countries
Netherlands
Outcome results
None listed