stress urinary incontinence. Urine leakage
Conditions
Interventions
None listed
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Referred for physical therapy to treat mixed (predominant SUI) or SUI - Right-handed - Female, between the age of 18 up to and including 60 years old - Signed informed consent
Exclusion criteria
Exclusion criteria: - Using any medication for urinary complaints. - Using any medication which may influence the function of the lower urinary tract (i.e. neuroleptics, anti-depressants, morphine-like medication). - Having had PFMT in the past six months. - Any known neurological disorder. - Any known psychiatric disorder.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in the oxygenated haemoglobin concentration in the motor and sensory cortex, change in the deoxygenated haemoglobin concentration in the motor and sensory cortex change in pelvic floor muscle force, change in pelvic floor muscle endurance, change in pelvic floor coordination, change in symptom severity, change in health related quality of life, correlation between cortical activation measured by fNIRS (oxygenated haemoglobin) and pelvic floor activity measured by EMG. | — |
Secondary
| Measure | Time frame |
|---|---|
| The secondary outcomes are: change of the deoxygenated haemoglobin concentration in the motor and sensory cortex, change in oxygenated and deoxygenated haemoglobin concentrations compared between baseline and six weeks, change in pelvic floor muscle force, change in pelvic floor muscle endurance, and change in pelvic floor muscle coordination which are measured with EMG using the MAPLe device. The correlation between fNIRS and pelvic floor EMG, change in pelvic floor related quality of life, and change in symptom severity (frequency of incontinence episodes) are additional secondary outcomes. These secondary outcomes will be assessed with validated questionnaires on symptoms and quality of life in pelvic health. The validated Dutch PRAFAB, UDI-6, IIQ-7, EQ-5D-5L, and HADS will be used to assess pelvic health related symptoms and quality of life. These outcome measures will be assessed at baseline and after six weeks. | — |
Countries
Netherlands
Outcome results
None listed