Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02059798|
Recruitment Status : Unknown
Verified February 2014 by Dong Sup Lee, The Catholic University of Korea.
Recruitment status was: Not yet recruiting
First Posted : February 11, 2014
Last Update Posted : February 11, 2014
Decompressive surgery of cervical myelopathy will improve bladder function.
Decompressive surgery of cervical myelopathy will improve sexual function.
|Condition or disease|
|Myelopathy Neurogenic Bladder Erectile Dysfunction Psychosexual Dysfunctions Sexual Arousal Disorder|
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 [Patient Registry]|
|Estimated Enrollment :||76 participants|
|Target Follow-Up Duration:||6 Months|
|Official Title:||Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||February 2016|
|Estimated Study Completion Date :||August 2016|
Decompression of cervical myelopathy
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit
- JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy [ Time Frame: 6 months after surgery ]This score will provide patients' conditions at a glance.
- 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.
- 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.
- Female sexual function index [ Time Frame: 6 months after surgery ]This will show the female patients' sexual arousal state.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059798
|Contact: Dong Sup Lee, MD, PhDfirstname.lastname@example.org|
|Contact: Ilsup Kim, MD, PhDemail@example.com|
|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 firstname.lastname@example.org|
|Study Chair:||Ilsup Kim, MD, PhD||The Catholic University of Korea|