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NCT02059798 Clinical Trial

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

Erectile Dysfunction Clinical Trial

Official title:
Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT02059798
Other study ID # L201402N1
Secondary ID
Status Not yet recruiting
Phase N/A
First received February 7, 2014
Last updated February 10, 2014
Start date March 2014
Est. completion date August 2016

Study information
Verified date February 2014
Source The Catholic University of Korea
Contact Dong Sup Lee, MD, PhD
Phone 82-31-249-8276
Email lds@catholic.ac.kr
Is FDA regulated No
Health authority Korea: Institutional Review Board
Study type Observational [Patient Registry]

Clinical Trial Summary

Hypotheses:

Decompressive surgery of cervical myelopathy will improve bladder function.

Decompressive surgery of cervical myelopathy will improve sexual function.

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

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 76
Est. completion date August 2016
Est. primary completion date February 2016
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 65 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
Korea, Republic of St. Vincent's Hospital, The Catholic University of Korea Suwon Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Other Rigidity activity unit of penis This study will be provided by nocturnal penile tumescence study and will show the intactness of psychogenic erectile pathway. 6 months after surgery No
Other Female sexual function index This will show the female patients' sexual arousal state. 6 months after surgery No
Primary JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy This score will provide patients' conditions at a glance. 6 months after surgery No
Secondary Bladder compliance This will be provided by urodynamic study, and will show the intactness of Guarding reflex from upper spinal cord tract. 6 months after surgery No
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