The main aim is to study whether fNIRS can measure cortical activation during pelvic floor muscle contraction and to study whether it is a reliable non-invasive alternative to invasive pelvic floor EMG in order to provide biofeedback during pelvic…
ID
Source
Brief title
Condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
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 can measure cortical activation during
pelvic floor muscle contraction and to study whether it 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 observational study.
Study burden and risks
This is an observational study. The included patients 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 patients 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 several control tasks. The
number of visits, 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
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 |
|---|---|
| CCMO | NL78195.078.21 |