Pelvic Floor Rehabilitation for Gynecological Cancer Patients

Phase 2

• Conditions: Malignant Female Reproductive System Neoplasm
• Interventions: Behavioral: pelvic floor rehabilitation program with neuromodulation

• Registration Number: NCT01871688
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2013-04-16
• Status Verified: 2013-06
• Study First Submitted QC: 2013-06-04
• Last Update Submitted: 2013-06-04
• Study First Posted: 2013-06-07
• Last Update Posted: 2013-06-07
• Primary Completion: 2014-07
• Study Completion: 2014-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• Women with gynecological cancer who had radical hysterectomy and pelvic lymph node dissection

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Exclusion Criteria

• infectious diseases of the urinary tract and vagina

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
pelvic floor exercise	pelvic floor rehabilitation program with neuromodulation	pelvic floor rehabilitation program with neuromodulation

Primary Outcome Measures

Name	Time	Method
Amplitude (uV) of motor evoked potential (MEP) evoked by magnetic stimulation on the sacral plexus.	1week after intervention	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

Name	Time	Method
pelvic floor muscle strength(mmHg)	baseline, up to 1week after intervention	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)	baseline, up to 1week after intervention	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	baseline, up to 1week after intervention	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	baseline, up to 1week after intervention	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	baseline, up to 1week after intervention	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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Korea, Republic of