Prostatic HyperplasiaNCT02243540
Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy
An observational study of Prostatic Hyperplasia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for… Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- How many people
- 1,828 participants
- Where
- 1 siteSouth Korea
- Study dates
- Apr 2014to Sep 2014
- 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 40 to 90 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: men who underwent photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical treatment
Who may be able to join
- patients in whom 12-month follow-up data were available
Who cannot join
- a previous diagnosis of urethral stricture
- prostate or bladder carcinoma
- neurogenic bladder disease
- a previous history of urological surgery
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 110-744
Jae-Seung Paick, M.D., Ph.D., 82-2-2072-2422 ext. 2422, jspaick@snu.ac.kr
About this study
Official title: Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for benign prostatic hyperplasia.
- Conditions
- Prostatic Hyperplasia
- Medical subject headings
- Prostatic Hyperplasia
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline bladder voiding efficiency at 12 months after surgery
bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume)
Measured: 12-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2014 (estimated)
- Study startApr 2014
- Primary completionSep 2014 (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.
- More trials run by Seoul National University HospitalThe 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
- Retrospective
- Enrolment
- 1,828 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jae-Seung Paick, Seoul National University Hospital
- Investigators
- Jae-Seung Paick, M.D., Ph.D., Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02243540
- Sponsor's protocol ID
- JSPaick1
- Status last verified
- Sep 2014
- First submitted
- 14 Sep 2014
- Last updated
- 18 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Bladder Underactivity on Treatment Outcomes of Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT02243540
- Acronym / sponsor ID
- JSPaick1
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,828 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Sep 2014 (estimated)
- First posted
- 18 Sep 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.
The aim of this study was to evaluate an impact of preoperative bladder underactivity on treatment outcomes of photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) in the treatment of benign prostatic obstruction, and to compare it between the two types of surgery for benign prostatic hyperplasia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- men who underwent photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) for benign prostatic hyperplasia refractory to medical treatment
Key inclusion criteria (1 listed)
- patients in whom 12-month follow-up data were available
Key exclusion criteria (4 listed)
- a previous diagnosis of urethral stricture
- prostate or bladder carcinoma
- neurogenic bladder disease
- a previous history of urological surgery
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
Change from baseline bladder voiding efficiency at 12 months after surgery
Time frame: 12-months postoperatively
bladder voiding efficiency = voided volume x 100 / (voided volume + post-void residual urine volume)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 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.
Jae-Seung Paick, M.D., Ph.D. principal investigator
Seoul National University Hospital
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 Seoul National University Hospital 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 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 18 Sep 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 Jae-Seung Paick, M.D., Ph.D. (82-2-2072-2422 ext. 2422, jspaick@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline bladder voiding efficiency at 12 months after surgery (time frame: 12-months postoperatively). 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 18 Sep 2014; AzTrials last refreshed its copy on 8 Nov 2026.