Prostatic HyperplasiaNCT02033785
Functional Changes of Urogenital System After Holmium Laser Prostatectomy
An observational study of Prostatic Hyperplasia, run by The Catholic University of Korea at 1 site in South Korea.
Trial summary
Holmium laser prostatectomy will enhance voiding function. Holmium laser prostatectomy will enhance sleep quality. Holmium laser prostatectomy will enhance renal function. Holmium laser prostatectomy will enhance erectile function. Holmium laser prostatectomy will enhance the health-related quality of life. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- How many people
- 86 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Mar 2016
- How long will I take part?
- 1 Year
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Primary Care Clinic
Who may be able to join
- Prostate size over 30 cc by transrectal ultrasonography
- prostate-specific antigen level less than 10 ng/ml
- International prostate symptom score more than 7
- At least one of followings: Bladder outlet obstruction index > 40, maximal flow rate < 10 cc/sec, postvoid residual urine >100cc or schäfer grade II or more
Who cannot join
- Patients who do not want surgery
- Evidence of prostate cancer or bladder cancer during evaluation or treatment
- All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
- Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
- History of pelvic radiation therapy
- Poorly controlled diabetes mellitus or hypertension
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
About this study
Official title: Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients
Holmium laser prostatectomy will enhance voiding function.
Holmium laser prostatectomy will enhance sleep quality.
Holmium laser prostatectomy will enhance renal function.
Holmium laser prostatectomy will enhance erectile function.
Holmium laser prostatectomy will enhance the health-related quality of life.
Read the detailed description
Check urodynamic parameters for voiding function evaluation Check low urinary tract symptoms (IPSS: international prostate symptom score) for voiding function evaluation Check Pittsburgh Sleep Quality Index for sleep quality evaluation Check estimated glomerular filtration rate and urine protein/creatinine ratio for renal function evaluation Check International Index of Erectile Function score (IIEF-5) for erectile function evaluation Check nocturnal penile tumescence parameters for erectile function evaluation Check 36-Item Short- Form Health Survey (SF-36) for evaluation of the health-related quality of life.
- Conditions
- Prostatic Hyperplasia
- Keywords
- Prostatic hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximal flow rate
This parameter can be obtained from urodynamic study.
Measured: 3 months
Maximal detrusor pressure
This parameter can be obtained from urodynamic study.
Measured: 3 months
Bladder outlet obstruction index
This parameter can be obtained from urodynamic study.
Measured: 3 months
schäfer grade
This parameter can be obtained from urodynamic study.
Measured: 3 months
Compliance
This parameter can be obtained from urodynamic study.
Measured: 3 months
Secondary outcomes (5)
Maximal flow rate
This parameter can be obtained from urodynamic study.
Measured: 12 months
Maximal detrusor pressure
This parameter can be obtained from urodynamic study.
Measured: 12 months
Bladder outlet obstruction index
This parameter can be obtained from urodynamic study.
Measured: 12 months
schäfer grade
This parameter can be obtained from urodynamic study.
Measured: 12 months
Compliance
This parameter can be obtained from urodynamic study.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2014 (estimated)
- Study startFeb 2014
- Primary completionFeb 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies 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
- 86 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- The Catholic University of Korea
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Ju Lee, The Catholic University of Korea
- Investigators
- Seung-Ju Lee, Study chair, The Catholic University of KoreaDong Sup Lee, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02033785
- Sponsor's protocol ID
- L201401N1
- Other IDs
- VC13OISI0222
- Status last verified
- Jan 2014
- First submitted
- 7 Jan 2014
- Last updated
- 13 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Holmium Laser Prostatectomy For Observing Functional Changes in Benign Prostate Hyperplasia Patients
- ClinicalTrials.gov ID
- NCT02033785
- Acronym / sponsor ID
- L201401N1
- Conditions
- Prostatic Hyperplasia
- Keywords
- Prostatic hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- The Catholic University of KoreaUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Feb 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 13 Jan 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.
Holmium laser prostatectomy will enhance voiding function.
Holmium laser prostatectomy will enhance sleep quality.
Holmium laser prostatectomy will enhance renal function.
Holmium laser prostatectomy will enhance erectile function.
Holmium laser prostatectomy will enhance the health-related quality of life.
Detailed description
Check urodynamic parameters for voiding function evaluation Check low urinary tract symptoms (IPSS: international prostate symptom score) for voiding function evaluation Check Pittsburgh Sleep Quality Index for sleep quality evaluation Check estimated glomerular filtration rate and urine protein/creatinine ratio for renal function evaluation Check International Index of Erectile Function score (IIEF-5) for erectile function evaluation Check nocturnal penile tumescence parameters for erectile function evaluation Check 36-Item Short- Form Health Survey (SF-36) for evaluation of the health-related quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary Care Clinic
Key inclusion criteria (4 listed)
- Prostate size over 30 cc by transrectal ultrasonography
- prostate-specific antigen level less than 10 ng/ml
- International prostate symptom score more than 7
- At least one of followings: Bladder outlet obstruction index > 40, maximal flow rate < 10 cc/sec, postvoid residual urine >100cc or schäfer grade II or more
Key exclusion criteria (6 listed)
- Patients who do not want surgery
- Evidence of prostate cancer or bladder cancer during evaluation or treatment
- All of followings: Bladder outlet obstruction index is less than 40, maximal flow rate is 10 or more cc/sec, postvoid residual urine is less than 100cc and schäfer grade II or less
- Major depressive disorder, Dementia, Parkinson's disease, Neurological deficits
- History of pelvic radiation therapy
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
Maximal flow rate
Time frame: 3 months
This parameter can be obtained from urodynamic study.
Maximal detrusor pressure
Time frame: 3 months
This parameter can be obtained from urodynamic study.
Bladder outlet obstruction index
Time frame: 3 months
This parameter can be obtained from urodynamic study.
schäfer grade
Time frame: 3 months
This parameter can be obtained from urodynamic study.
Compliance
Time frame: 3 months
This parameter can be obtained from urodynamic study.
5 secondary outcomes
Maximal flow rate
Time frame: 12 months
Maximal detrusor pressure
Time frame: 12 months
Bladder outlet obstruction index
Time frame: 12 months
schäfer grade
Time frame: 12 months
Compliance
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2014.
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ProVIDE Studies Post Exit Analysis
BPH With Symptomatic Lower Urinary Tract Symptoms
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Learning Curve of Tri-lobar HoLEP Versus En-bloc HoLEP
Benign Prostatic Hyperplasia With Outflow Obstruction
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Impact of Long-term Dutasteride Use on Perioperative Outcomes of HoLEP
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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.
Seung-Ju Lee study chair
The Catholic University of Korea
Dong Sup Lee principal investigator
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 Prostatic Hyperplasia, 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 4 inclusion and 6 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 13 Jan 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 Seung-Ju Lee, MD, PhD (82-31-249-8305, lee.seungju@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal flow rate (time frame: 3 months). The study lists 5 primary outcomes in all. 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 13 Jan 2014.