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Functional near-infrared spectroscopy as biofeedback to assist pelvic floor muscle training: a randomized controlled trial.

Functional near-infrared spectroscopy as biofeedback to assist pelvic floor muscle training: a randomized controlled trial. - fNIRS and pelvic floor muscle training.

Status
Unknown
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50823
Enrollment
30
Registered
2021-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

stress urinary incontinence. Urine leakage

Interventions

None listed

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 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

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)