Benign Prostatic Hyperplasia (BPH)NCT03460873
Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
An observational study of Benign Prostatic Hyperplasia (BPH), run by Samsung Medical Center at 1 site in South Korea.
Trial summary
Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- holmium laser enucleation of the prostate
- Type of treatment
- Surgery or procedure
- How many people
- 432 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2015to 28 Nov 2019
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: tertiary hospital
Who may be able to join
- Male patient scheduled to undergo prostatectomy using holmium laser
Who cannot join
- Urethral stricture, large bladder diverticulum, bladder neck contracture
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Samsung Medical Center, Sungkyunkwan University School of Medicine
Seoul, 135-710
About this study
Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Being tested
- holmium laser enucleation of the prostate
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holmium laser enucleation of the prostateProcedure or surgery
undergo holmium laser enucleation of the prostate
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of IPSS(International Prostate Symptom Score) changes
Complete the questionnaire(IPSS) before and after the treatment
Measured: pre-operation and post-operation (3month, 6month)
Secondary outcomes (3)
changes of voided urine volume
Comparison of voided urine volume
Measured: pre-operation and post-operation (3month, 6month)
changes of residual urine volume
Comparison of residual urine volume
Measured: pre-operation and post-operation (3month, 6month)
Occurrence of adverse event
collection of adverse event
Measured: post-operation (3month, 6month)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2018
- Study startSep 2015
- Primary completion7 Nov 2019
- Study completion28 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe sponsor's other registered studies.
- 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
- 432 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, KYU-SUNG LEE, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03460873
- Sponsor's protocol ID
- 2015-11-037
- Status last verified
- Nov 2019
- First submitted
- 27 Feb 2018
- Last updated
- 2 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Factor in the Patients With Benign Prostatic Hyperplasia Who Undergo Holmium Laser Enucleation of the Prostate
- ClinicalTrials.gov ID
- NCT03460873
- Acronym / sponsor ID
- 2015-11-037
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 432 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- 7 Nov 2019 (actual)
- Study completion
- 28 Nov 2019 (actual)
- First posted
- 9 Mar 2018 (actual)
- 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.
Prognostic factor in the patients with benign prostatic hyperplasia (BPH) who undergo holmium laser enucleation of the prostate
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- tertiary hospital
Key inclusion criteria (1 listed)
- Male patient scheduled to undergo prostatectomy using holmium laser
Key exclusion criteria (1 listed)
- Urethral stricture, large bladder diverticulum, bladder neck contracture
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| holmium laser enucleation of the prostateundergo holmium laser enucleation of the prostate | Procedure or surgery | – |
Primary outcome
Comparison of IPSS(International Prostate Symptom Score) changes
Time frame: pre-operation and post-operation (3month, 6month)
Complete the questionnaire(IPSS) before and after the treatment
3 secondary outcomes
changes of voided urine volume
Time frame: pre-operation and post-operation (3month, 6month)
changes of residual urine volume
Time frame: pre-operation and post-operation (3month, 6month)
Occurrence of adverse event
Time frame: post-operation (3month, 6month)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Benign Prostatic Hyperplasia (BPH), run by Samsung Medical Center 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 2 Dec 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of IPSS(International Prostate Symptom Score) changes (time frame: pre-operation and post-operation (3month, 6month)). 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 2 Dec 2019.