Clinical trial NCT01871688: Pelvic Floor Rehabilitation for Gynecological Cancer Patients
Official title: Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Malignant Female Reproductive System Neoplasm
Keywords: pelvic floor dysfunction
neuromodulation
rehabilitation
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
First posted: 2013-06-07
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: As cancer treatment improves, the cancer survivor's quality of life and level of function have gained increasing importance. Pelvic floor function is directly affected by gynecological cancer and treatment, and pelvic floor dysfunction (PFD) can severely affect a patient's life. PFD negatively affects health-related quality of life (HRQOL). Evaluation of PFD provides information about the disease burden and treatment-related effects directly from the patient's perspective and informs clinical decision-making. The pelvic floor musculature and sacral nerves are not easily accessible, and it is difficult to test them. Several functional assessments have been used to evaluate pelvic floor dysfunction; however, reports on methodology are sparse, and consensus on their use is lacking. Research on functional outcomes is highly complex and, consequently, must be addressed in a comprehensive framework.

Detailed description: 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, threshold1.5V).
* 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 facilitation
* 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.

Eligibility criteria: Inclusion Criteria:

* Women with gynecological cancer who had radical hysterectomy and pelvic lymph node dissection

Exclusion Criteria:

* infectious diseases of the urinary tract and vagina

Primary outcomes:
measure: Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.
timeFrame: 1week after intervention
Secondary outcomes:
measure: pelvic floor muscle strength(mmHg)
timeFrame: baseline, up to 1week after intervention
measure: latency (ms) of MEP (motor evoked potential)
timeFrame: baseline, up to 1week after intervention
measure: Functional score and symptom scale of QuEORTC QLQ-C-30,EORTC CX-24
timeFrame: baseline, up to 1week after intervention
measure: Total Bladder, bowel,sexual functional scores measured by the pelvic floor questionnaire
timeFrame: baseline, up to 1week after intervention
measure: Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction measure with ultrasound
timeFrame: baseline, up to 1week after intervention
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Eun Joo Yang, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: