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Pelvic Floor Rehabilitation for Gynecological Cancer Patients

Primary Purpose

Malignant Female Reproductive System Neoplasm

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
pelvic floor rehabilitation program with neuromodulation
Sponsored by
Seoul National University Bundang Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Malignant Female Reproductive System Neoplasm focused on measuring pelvic floor dysfunction, neuromodulation, rehabilitation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Seoul National University Bundang HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

pelvic floor exercise

Arm Description

pelvic floor rehabilitation program with neuromodulation

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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
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.
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
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

Full Information

First Posted
April 16, 2013
Last Updated
June 4, 2013
Sponsor
Seoul National University Bundang Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01871688
Brief Title
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

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (undefined)
Primary Completion Date
July 2014 (Anticipated)
Study Completion Date
July 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Bundang Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Female Reproductive System Neoplasm
Keywords
pelvic floor dysfunction, neuromodulation, rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
pelvic floor exercise
Arm Type
Other
Arm Description
pelvic floor rehabilitation program with neuromodulation
Intervention Type
Behavioral
Intervention Name(s)
pelvic floor rehabilitation program with neuromodulation
Intervention Description
pelvic floor rehabilitation program with neuromodulation
Primary Outcome Measure Information:
Title
Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.
Description
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.
Time Frame
1week after intervention
Secondary Outcome Measure Information:
Title
pelvic floor muscle strength(mmHg)
Description
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.
Time Frame
baseline, up to 1week after intervention
Title
latency (ms) of MEP (motor evoked potential)
Description
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
Time Frame
baseline, up to 1week after intervention
Title
Functional score and symptom scale of QuEORTC QLQ-C-30,EORTC CX-24
Description
We evaluate the functional score and symptom scale with EORTC QLQ-C30, EORTC QLQ-CX24 questionnaires and compare the change between two groups.
Time Frame
baseline, up to 1week after intervention
Title
Total Bladder, bowel,sexual functional scores measured by the pelvic floor questionnaire
Description
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
Time Frame
baseline, up to 1week after intervention
Title
Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction measure with ultrasound
Description
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
Time Frame
baseline, up to 1week after intervention

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eun Joo Yang, MD.PhD
Phone
82-787-7734
Email
graceloves@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eun Joo Yang, MD, PhD
Organizational Affiliation
Seoul National University Bundang Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Bundang Hospital
City
Seongnam
ZIP/Postal Code
463-707
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eun Joo Yang, MD. PhD
Phone
82-787-7734
Email
graceloves@gmail.com

12. IPD Sharing Statement

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Pelvic Floor Rehabilitation for Gynecological Cancer Patients

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