Pelvic Floor Rehabilitation for Gynecological Cancer Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Eun Joo Yang, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01871688
First received: April 16, 2013
Last updated: June 4, 2013
Last verified: June 2013
  Purpose

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.


Condition Intervention Phase
Malignant Female Reproductive System Neoplasm
Behavioral: pelvic floor rehabilitation program with neuromodulation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Neuromodulation System for Pelvic Floor Dysfunction Based on the Myo-neurophysiological Assessment for Gynecological Cancer Patients

Resource links provided by NLM:


Further study details as provided by Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus. [ Time Frame: 1week after intervention ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: baseline, up to 1week after intervention ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: baseline, up to 1week after intervention ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, up to 1week after intervention ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, up to 1week after intervention ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: baseline, up to 1week after intervention ] [ Designated as safety issue: Yes ]
    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


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
pelvic floor exercise
pelvic floor rehabilitation program with neuromodulation
Behavioral: pelvic floor rehabilitation program with neuromodulation
pelvic floor rehabilitation program with neuromodulation
Other Name: 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871688

Contacts
Contact: Eun Joo Yang, MD.PhD 82-787-7734 graceloves@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Korea, Republic of, 463-707
Contact: Eun Joo Yang, MD. PhD    82-787-7734    graceloves@gmail.com   
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Principal Investigator: Eun Joo Yang, MD, PhD Seoul National University Bundang Hospital
  More Information

No publications provided

Responsible Party: Eun Joo Yang, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01871688     History of Changes
Other Study ID Numbers: B-0906/077-010
Study First Received: April 16, 2013
Last Updated: June 4, 2013
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
pelvic floor dysfunction
neuromodulation
rehabilitation

Additional relevant MeSH terms:
Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on August 26, 2014