MyelopathyNCT02059798
Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy
An observational study of Myelopathy and Neurogenic Bladder, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Hypotheses: Decompressive surgery of cervical myelopathy will improve bladder function. Decompressive surgery of cervical myelopathy will improve sexual function. Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Myelopathy, Neurogenic Bladder, Erectile Dysfunction
- How many people
- 76 participants
- Where
- 1 siteSouth Korea
- Study dates
- Mar 2014to Aug 2016
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients having cervical myelopathy, aged between 25 and 65
Who may be able to join
- evidence of progression of motor or sensory nerve
- cervical myelopathy in magnetic resonance imaging
Who cannot join
- radical pelvic surgery
- pelvic irradiation
- evidence of brain damage (dementia, cerebrovascular disease)
- evidence of psychotic disorder
Trial locations and contacts
1 site in 1 country.
South Korea1 site
St. Vincent's Hospital, The Catholic University of Korea
Suwon, Gyeonggi-do, 442-723
Dong Sup Lee, MD, PhD, 82-31-249-8276, lds@catholic.ac.kr
About this study
Hypotheses:
Decompressive surgery of cervical myelopathy will improve bladder function.
Decompressive surgery of cervical myelopathy will improve sexual function.
Read the 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
- Conditions
- Myelopathy, Neurogenic Bladder, Erectile Dysfunction, Psychosexual Dysfunctions, Sexual Arousal Disorder
- Keywords
- Myelopathy
- Medical subject headings
- Spinal Cord Diseases, Urinary Bladder, Neurogenic, Erectile Dysfunction, Sexual Dysfunctions, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Decompression of cervical myelopathy | JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
This score will provide patients' conditions at a glance.
Measured: 6 months after surgery
Secondary outcomes (1)
Bladder compliance
This will be provided by urodynamic study, and will show the intactness of Guarding reflex from upper spinal cord tract.
Measured: 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionFeb 2016 (estimated)
- Study completionAug 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyelopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dong Sup Lee, The Catholic University of Korea
- Investigators
- Ilsup Kim, MD, PhD, Study chair, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059798
- Sponsor's protocol ID
- L201402N1
- Status last verified
- Feb 2014
- First submitted
- 7 Feb 2014
- Last updated
- 11 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urinary and Sexual Function Before and After Surgical Decompression of Cervical Myelopathy
- ClinicalTrials.gov ID
- NCT02059798
- Acronym / sponsor ID
- L201402N1
- Conditions
- Myelopathy, Neurogenic Bladder, Erectile Dysfunction, Psychosexual Dysfunctions, Sexual Arousal Disorder
- Keywords
- Myelopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Aug 2016 (estimated)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypotheses:
Decompressive surgery of cervical myelopathy will improve bladder function.
Decompressive surgery of cervical myelopathy will improve sexual function.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Decompression of cervical myelopathy | – | –JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy Compliance Rigidity activity unit |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients having cervical myelopathy, aged between 25 and 65
Key inclusion criteria (2 listed)
- evidence of progression of motor or sensory nerve
- cervical myelopathy in magnetic resonance imaging
Key exclusion criteria (4 listed)
- radical pelvic surgery
- pelvic irradiation
- evidence of brain damage (dementia, cerebrovascular disease)
- evidence of psychotic disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy
Time frame: 6 months after surgery
This score will provide patients' conditions at a glance.
1 secondary outcome
Bladder compliance
Time frame: 6 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ilsup Kim, MD, PhD study chair
The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myelopathy and Neurogenic Bladder, run by The Catholic University of Korea at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dong Sup Lee, MD, PhD (82-31-249-8276, lds@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
JOA (Japanese Orthopaedic Association) Scores for cervical myelopathy (time frame: 6 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2014.