NCT02059798

Brief Summary

Hypotheses: Decompressive surgery of cervical myelopathy will improve bladder function. Decompressive surgery of cervical myelopathy will improve sexual function.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
76

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 7, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 11, 2014

Completed
18 days until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2016

Completed
Last Updated

February 11, 2014

Status Verified

February 1, 2014

Enrollment Period

1.9 years

First QC Date

February 7, 2014

Last Update Submit

February 10, 2014

Conditions

MyelopathyNeurogenic BladderErectile DysfunctionPsychosexual DysfunctionsSexual Arousal Disorder

Keywords

Myelopathy

Outcome Measures

Primary Outcomes (1)

  • JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy

    This score will provide patients' conditions at a glance.

    6 months after surgery

Secondary Outcomes (1)

  • Bladder compliance

    6 months after surgery

Other Outcomes (2)

  • Rigidity activity unit of penis

    6 months after surgery

  • Female sexual function index

    6 months after surgery

Study Arms (1)

Decompression of cervical myelopathy

JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients having cervical myelopathy, aged between 25 and 65

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Vincent's Hospital, The Catholic University of Korea

Suwon, Gyeonggi-do, 442-723, South Korea

Location

MeSH Terms

Conditions

Spinal Cord DiseasesUrinary Bladder, NeurogenicErectile DysfunctionSexual Dysfunctions, Psychological

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesNeurologic ManifestationsUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsGenital Diseases, MaleGenital DiseasesSexual Dysfunction, PhysiologicalMental Disorders

Study Officials

  • Ilsup Kim, MD, PhD

    The Catholic University of Korea

    STUDY CHAIR

Central Study Contacts

Dong Sup Lee, MD, PhD

CONTACT

82-31-249-8276lds@catholic.ac.kr

Ilsup Kim, MD, PhD

CONTACT

82-31-249-7190nsman72@hanmail.net

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Senior researcher

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 11, 2014

Study Start

March 1, 2014

Primary Completion

February 1, 2016

Study Completion

August 1, 2016

Last Updated

February 11, 2014

Record last verified: 2014-02

Locations

KR(1)