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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified February 2014 by The Catholic University of Korea
Sponsor:
Information provided by (Responsible Party):
Dong Sup Lee, The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT02059798
First received: February 7, 2014
Last updated: February 10, 2014
Last verified: February 2014
  Purpose

Hypotheses:

Decompressive surgery of cervical myelopathy will improve bladder function.

Decompressive surgery of cervical myelopathy will improve sexual function.


Condition
Myelopathy
Neurogenic Bladder
Erectile Dysfunction
Psychosexual Dysfunctions
Sexual Arousal Disorder

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Months
Official Title: Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy

Resource links provided by NLM:


Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    This score will provide patients' conditions at a glance.


Secondary Outcome Measures:
  • Bladder compliance [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    This will be provided by urodynamic study, and will show the intactness of Guarding reflex from upper spinal cord tract.


Other Outcome Measures:
  • Rigidity activity unit of penis [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    This study will be provided by nocturnal penile tumescence study and will show the intactness of psychogenic erectile pathway.

  • Female sexual function index [ Time Frame: 6 months after surgery ] [ Designated as safety issue: No ]
    This will show the female patients' sexual arousal state.


Estimated Enrollment: 76
Study Start Date: March 2014
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Decompression of cervical myelopathy
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit

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
  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients having cervical myelopathy, aged between 25 and 65

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02059798

Contacts
Contact: Dong Sup Lee, MD, PhD 82-31-249-8276 lds@catholic.ac.kr
Contact: Ilsup Kim, MD, PhD 82-31-249-7190 nsman72@hanmail.net

Locations
Korea, Republic of
St. Vincent's Hospital, The Catholic University of Korea Not yet recruiting
Suwon, Gyeonggi-do, Korea, Republic of, 442-723
Contact: Dong Sup Lee, MD, PhD    82-31-249-8276    lds@catholic.ac.kr   
Sponsors and Collaborators
The Catholic University of Korea
Investigators
Study Chair: Ilsup Kim, MD, PhD The Catholic University of Korea
  More Information

No publications provided

Responsible Party: Dong Sup Lee, Senior researcher, The Catholic University of Korea
ClinicalTrials.gov Identifier: NCT02059798     History of Changes
Other Study ID Numbers: L201402N1
Study First Received: February 7, 2014
Last Updated: February 10, 2014
Health Authority: Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
Myelopathy

Additional relevant MeSH terms:
Bone Marrow Diseases
Erectile Dysfunction
Urinary Bladder, Neurogenic
Sexual Dysfunctions, Psychological
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual and Gender Disorders
Mental Disorders
Hematologic Diseases
Neurologic Manifestations
Nervous System Diseases
Urinary Bladder Diseases
Urologic Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014