The main aim is to study whether fNIRS is a reliable non-invasive alternative to invasive pelvic floor EMG in order to provide biofeedback during pelvic floor physical therapy in patients with SUI.
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameter is change in cortical activation during pelvic floor
muscle contraction. Activation is measured as the oxygenated/deoxygenated
haemoglobin ratio in the cerebral cortex, measured with fNIRS.
Secondary outcome
The secondary outcomes are: 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.
Background summary
The primary treatment of stress urinary incontinence (SUI) is pelvic floor
physical therapy which sometimes includes invasive EMG measurement of the
pelvic floor musculature. A possible non-invasive alternative to indirectly
measure pelvic floor muscle activity is functional near-infrared spectroscopy
(fNIRS). FNIRS is a functional neuroimaging modality that measures changes in
oxygenation of the cerebral cortex.
Study objective
The main aim is to study whether fNIRS is a reliable non-invasive alternative
to invasive pelvic floor EMG in order to provide biofeedback during pelvic
floor physical therapy in patients with SUI.
Study design
A prospective randomized controlled trial.
Study burden and risks
The intervention groups will have seven site visits at the Erasmus MC, a visit
at baseline and a follow-up visit six weeks later, in-between these patients
have weekly in office physical therapy sessions, this is standard care. The
Control group has two site visits, one at baseline and one six weeks later,
they perform pelvic floor exercises in-between at home as instructed by a
leaflet, after the study period they will be offered standard care. Both groups
will have a site visit at baseline and six weeks later of approximately 60
minutes. These visits consist of physical examination, anamnesis, filling in
five validated questionnaires, and the measurements of pelvic floor EMG and
fNIRS during a block paradigm including pelvic floor muscle contractions and a
control task. The physical examination, anamneses, filling out one of five
questionnaires, and pelvic floor EMG are part of standard care. Additionally 4
short questionnaires are filled out and fNIRS measurements are performed which
are part of this study but not part of standard care. The risks are negligible.
The usage of the intravaginal EMG probe (MAPLe device) is part of standard
clinical practice in pelvic floor physical therapy. No further burden or risks,
other than the usual burden and risks that are associated with pelvic floor
physical therapy, associated with participation are expected.
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Dr. Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
- 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
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 |
|---|---|
| CCMO | NL75816.078.20 |