Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients
Patients with cervical or colorectal cancer who underwent surgery or radiotherapy are
recruited for the study.
- PFM strength is measured using a perineometer
(BioCon-200,McubeTechnologyCompany,Seoul,Korea). Vaginal pressure is measured using a
vaginal silicon pressure sensor (cmH2O; sensitivity0.06kPa,sensitivity 5mV,
- The motor evoked potentials (MEPs) from the pelvic floor are obtained by sacral and
transcranial magnetic stimulation using a Magstim 200 stimulator (Magstim Co.,
Whitland, Wales, UK). Patients are instructed to lie in the left lateral decubitus
position,intra-anal sponge electrode (Dantec,Skovlund, Denmark)was lubricated and
gently inserted into the anal canal.
- Monophasic single pulses of magnetic stimuli were delivered to the vertex corresponding
to the primary motor center in the precentral gyrus using a double-cone
coil(9902-00,Magstim). A figure-eight coil(9762-00,Magstim)was used to stimulate the
dorsolateral area of the sacrum corresponding to the exit of the sacral cortical
- We measured the latency, amplitude, and excitability threshold(ET) of MEPs detected in
pelvic floor muscles with and without facilitation. The excitability threshold at
rest(RET) is defined as the lowest intensity that produced MEP responses of 100μV For
optimal facilitation, we measure the latency of the MEPs with minimal contraction (10%
of MVC) with RET intensity and amplitude with a moderate contraction
- Patient-reported HRQOL Quality of life General and condition-specific aspects of HRQOL
were assessed using the EORTC QLQ-C30 questionnaires.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.
We measure the amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus at the baseline and 1wk after intervention. Then we compare the change of the amplitude (1 wk after intervention-baseline)between two groups.
1week after intervention
Eun Joo Yang, MD, PhD
Seoul National University Bundang Hospital
Korea: Institutional Review Board