Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy

February 10, 2014 updated by: Dong Sup Lee, The Catholic University of Korea

Hypotheses:

Decompressive surgery of cervical myelopathy will improve bladder function.

Decompressive surgery of cervical myelopathy will improve sexual function.

Study Overview

Status

Unknown

Conditions

Detailed Description

The investigators will enroll consecutive cohort with cervical myelopathy who are scheduled to take surgical decompression of cervical spinal cord, aged between 25 and 65.

The exams for the patients include followings

  • JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
  • VAS (Visual Analog Scale) pain score
  • IPSS (International Prostate Symptom Score) and IIEF (International Index of Erectile Function) in male patients
  • FSFI (Female Sexual Function Index) and UDI (Urinary Distress Inventory) in female patients
  • Bladder compliance, Detrusor leak point pressure, Peak detrusor pressure
  • Rigidity activity unit of penis

Study Type

Observational

Enrollment (Anticipated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Suwon, Gyeonggi-do, Korea, Republic of, 442-723
        • St. Vincent's Hospital, The Catholic University of Korea

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients having cervical myelopathy, aged between 25 and 65

Description

Inclusion Criteria:

  • evidence of progression of motor or sensory nerve
  • cervical myelopathy in magnetic resonance imaging

Exclusion Criteria:

  • radical pelvic surgery
  • pelvic irradiation
  • evidence of brain damage (dementia, cerebrovascular disease)
  • evidence of psychotic disorder

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Decompression of cervical myelopathy
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
Time Frame: 6 months after surgery
This score will provide patients' conditions at a glance.
6 months after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bladder compliance
Time Frame: 6 months after surgery
This will be provided by urodynamic study, and will show the intactness of Guarding reflex from upper spinal cord tract.
6 months after surgery

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Rigidity activity unit of penis
Time Frame: 6 months after surgery
This study will be provided by nocturnal penile tumescence study and will show the intactness of psychogenic erectile pathway.
6 months after surgery
Female sexual function index
Time Frame: 6 months after surgery
This will show the female patients' sexual arousal state.
6 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

  • Study Chair: Ilsup Kim, MD, PhD, The Catholic University of Korea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2016

Study Completion (ANTICIPATED)

August 1, 2016

Study Registration Dates

First Submitted

February 7, 2014

First Submitted That Met QC Criteria

February 10, 2014

First Posted (ESTIMATE)

February 11, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

February 11, 2014

Last Update Submitted That Met QC Criteria

February 10, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • L201402N1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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