Pelvic Floor Rehabilitation for Gynecological Cancer Patients

NCT ID: NCT01871688

Last Updated: 2013-06-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2014-07-31

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.

Conditions

Malignant Female Reproductive System Neoplasm

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

pelvic floor exercise

pelvic floor rehabilitation program with neuromodulation

Group Type: OTHER

pelvic floor rehabilitation program with neuromodulation

Intervention Type: BEHAVIORAL

pelvic floor rehabilitation program with neuromodulation

Interventions

pelvic floor rehabilitation program with neuromodulation

pelvic floor rehabilitation program with neuromodulation

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: lead

Responsible Party

Eun Joo Yang

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eun Joo Yang, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Bundang Hospital

Locations

Seoul National University Bundang Hospital

Seongnam, , South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Eun Joo Yang, MD.PhD

Role: CONTACT

graceloves@gmail.com

82-787-7734

Facility Contacts

Eun Joo Yang, MD. PhD

Role: primary

graceloves@gmail.com

82-787-7734

Other Identifiers

B-0906/077-010

Identifier Type: -

Identifier Source: org_study_id