Prostatic HyperplasiaNCT02073799
Storage Symptom After Laser Prostatectomy
An observational study of Prostatic Hyperplasia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). Read more about this study
- Who is it for?
- Ages 40 to 90 years, men only
- Conditions the study is for
- Prostatic Hyperplasia
- What is being tested?
- Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)
- Type of treatment
- Surgery or procedure
- How many people
- 486 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Mar 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: Patients who underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate and in whom 12-months follow-up data were available
Who may be able to join
- Clinical diagnosis of prostatic hyperplasia
- underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate
- 12-months follow-up data were available
Who cannot join
- previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Urology, Seoul National University Hospital
Seoul, Seoul, 110-744
Min Chul Cho, doctor of philosophy, 82-10-6271-4023, cmc1206@empal.com
Jae-Seung Paick, doctor of philosophy
About this study
Official title: Change in Storage Symptoms Following Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.
- Conditions
- Prostatic Hyperplasia
- Being tested
- Laser prostatectomy (Photoselective vaporization of the prostate or 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.
Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)Procedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Photoselective vaporization of the prostate | Patients who underwent photoselective vaporization of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available Receives: Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate) | |
| Holmium laser enucleation of the prostate | Patients who underwent holmium laser enucleation of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available Receives: Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate) |
What is being measured
The primary outcome is the main question the study is designed to answer.
the subtotal storage symptom score of the International Prostate Symptom Score (IPSS)
a reduction by ≥ 50% of the subtotal storage symptom score according to the International Prostate Symptom Score (IPSS) after the surgery compared to baseline
Measured: 12 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 posted27 Feb 2014 (estimated)
- Study startFeb 2014
- Primary completionMar 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
- 486 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02073799
- Sponsor's protocol ID
- LaserP1
- Status last verified
- Feb 2014
- First submitted
- 23 Feb 2014
- Last updated
- 27 Feb 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Change in Storage Symptoms Following Laser Prostatectomy: Comparison Between Potassium-titanyl-phosphate Photoselective Vaporization of the Prostate (PVP) and Holmium Laser Enucleation of the Prostate (HoLEP)
- ClinicalTrials.gov ID
- NCT02073799
- Acronym / sponsor ID
- LaserP1
- Conditions
- Prostatic Hyperplasia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 486 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Mar 2014 (estimated)
- First posted
- 27 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.
Recent literature indicated that postoperative storage symptoms after Photoselective vaporization of the prostate (PVP) or holmium laser enucleation of the prostate (HoLEP) were often reported and generally more common than after transurethral prostatectomy (TURP). However, almost all literature focused on postoperative urgency or dysuria immediately after PVP or HoLEP. Thus, there has been a scarcity of data on serial changes of storage symptoms in the postoperative period after PVP or HoLEP and data on predicting factors that influence improvement in storage symptoms postoperatively. The aim of this study was to compare serial changes of postoperative storage symptoms between PVP and HoLEP, and to identify the predictors that influence improvement of storage symptoms postoperatively.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Photoselective vaporization of the prostate | – | Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)Patients who underwent photoselective vaporization of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available |
| Holmium laser enucleation of the prostate | – | Procedure: Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate)Patients who underwent holmium laser enucleation of the prostate for prostatic hyperplasia and in whom 12-months follow-up data were available |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate and in whom 12-months follow-up data were available
Key inclusion criteria (3 listed)
- Clinical diagnosis of prostatic hyperplasia
- underwent photoselective vaporization of the prostate or holmium laser enucleation of the prostate
- 12-months follow-up data were available
Key exclusion criteria (1 listed)
- previous diagnosis of urethral stricture, prostate carcinoma, and neurogenic bladder disease
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 |
|---|---|---|
| Laser prostatectomy (Photoselective vaporization of the prostate or Holmium laser enucleation of the prostate) | Procedure or surgery | Holmium laser enucleation of the prostate, Photoselective vaporization of the prostate |
Primary outcome
the subtotal storage symptom score of the International Prostate Symptom Score (IPSS)
Time frame: 12 months after surgery
a reduction by ≥ 50% of the subtotal storage symptom score according to the International Prostate Symptom Score (IPSS) after the surgery compared to baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 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.
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 3 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: status not confirmed, as of the sponsor's last update on 27 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 Jae-Seung Paick, doctor of philosophy (82-2-2072-2422, jspaick@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the subtotal storage symptom score of the International Prostate Symptom Score (IPSS) (time frame: 12 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 27 Feb 2014.