Pelvic Floor Rehabilitation for Gynecological Cancer Patients

Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients

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.

Study Overview

• Status: Unknown
• Conditions: Malignant Female Reproductive System Neoplasm
• Intervention / Treatment: Behavioral: pelvic floor rehabilitation program with neuromodulation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Eun Joo Yang, MD.PhD; Phone Number: 82-787-7734; Email: graceloves@gmail.com

Study Locations

• Korea, Republic of
  • Seongnam, Korea, Republic of, 463-707
    • Recruiting
    • Seoul National University Bundang Hospital
    • Contact: Eun Joo Yang, MD. PhD; Phone Number: 82-787-7734; Email: graceloves@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Triple

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: pelvic floor exercise; pelvic floor rehabilitation program with neuromodulation	Behavioral: pelvic floor rehabilitation program with neuromodulation; pelvic floor rehabilitation program with neuromodulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pelvic floor muscle strength(mmHg)	We measure the pelvic floor muscle strength using perometer (mmHg)at baseline and 1 wk after intervention then compare the change of pelvic floor muscle strength(1wk after intervention-baseline) between two groups.	baseline, up to 1week after intervention
latency (ms) of MEP (motor evoked potential)	We measure the latency (ms) of MEP evoked by magnetic stimulation on the sacral plexus and compare the change of latency (1wk after intervention-baseline)between two groups	baseline, up to 1week after intervention
Functional score and symptom scale of QuEORTC QLQ-C-30,EORTC CX-24	We evaluate the functional score and symptom scale with EORTC QLQ-C30, EORTC QLQ-CX24 questionnaires and compare the change between two groups.	baseline, up to 1week after intervention
Total Bladder, bowel,sexual functional scores measured by the pelvic floor questionnaire	We evaluated the bladder, bowel, sexual functional scores with the interviewer-administered pelvic floor questionnaire at baseline and 1wk after intervention then compare the change of the scores between two groups	baseline, up to 1week after intervention
Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction measure with ultrasound	We measure the Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction using ultrasound with curved transducer (3.5-6 MHz)at baseline and 1 wk after intervention and compare the change between two groups	baseline, up to 1week after intervention

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Investigators: Principal Investigator: Eun Joo Yang, MD, PhD, Seoul National University Bundang Hospital

Study record dates

Study Major Dates

• Study Start: April 1, 2013
• Primary Completion (Anticipated): July 1, 2014
• Study Completion (Anticipated): July 1, 2014

Study Registration Dates

• First Submitted: April 16, 2013
• First Submitted That Met QC Criteria: June 4, 2013
• First Posted (Estimate): June 7, 2013

Study Record Updates

• Last Update Posted (Estimate): June 7, 2013
• Last Update Submitted That Met QC Criteria: June 4, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: rehabilitation; neuromodulation; pelvic floor dysfunction
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female
• Other Study ID Numbers: B-0906/077-010