Pelvic Floor Rehabilitation for Gynecological Cancer Patients

NCT01871688 | Unknown Phase 2

• 1 other identifier: B-0906/077-010
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Female Reproductive System Neoplasm

Keywords

pelvic floor dysfunction; neuromodulation; rehabilitation

Outcome Measures

Primary Outcomes (1)

• 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.

  1week after intervention

Secondary Outcomes (5)

• pelvic floor muscle strength(mmHg)

  baseline, up to 1week after intervention

• latency (ms) of MEP (motor evoked potential)

  baseline, up to 1week after intervention

• Functional score and symptom scale of QuEORTC QLQ-C-30,EORTC CX-24

  baseline, up to 1week after intervention

• Total Bladder, bowel,sexual functional scores measured by the pelvic floor questionnaire

  baseline, up to 1week after intervention

• Hiatal dimension (mm) and levator plate angle (º) on maximal pelvic floor muscle contraction measure with ultrasound

  baseline, up to 1week after intervention

Study Arms (1)

pelvic floor exercise

OTHER

pelvic floor rehabilitation program with neuromodulation

Behavioral: pelvic floor rehabilitation program with neuromodulation

Interventions

pelvic floor rehabilitation program with neuromodulation BEHAVIORAL

pelvic floor rehabilitation program with neuromodulation

pelvic floor exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• infectious diseases of the urinary tract and vagina

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, 463-707, South Korea

RECRUITING

Study Officials

• Eun Joo Yang, MD, PhD

  Seoul National University Bundang Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eun Joo Yang, MD.PhD

CONTACT

82-787-7734; graceloves@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: April 16, 2013
• First Posted: June 7, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: June 7, 2013

Record last verified: 2013-06

Locations

KR (1)