Pelvic Floor Rehabilitation for Gynecological Cancer Patients

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Seoul National University

Status and phase

Unknown
Phase 3
Phase 2

Conditions

Malignant Female Reproductive System Neoplasm

Treatments

Behavioral: pelvic floor rehabilitation program with neuromodulation

Study type

Interventional

Funder types

Other

Identifiers

NCT01871688
B-0906/077-010

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

Triple Blind

100 participants in 1 patient group

pelvic floor exercise
Other group
Description:
pelvic floor rehabilitation program with neuromodulation
Treatment:
Behavioral: pelvic floor rehabilitation program with neuromodulation

Trial contacts and locations

1

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Central trial contact

Eun Joo Yang, MD.PhD

Data sourced from clinicaltrials.gov

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