Urologic DiseasesNCT06531473
Laser Outcomes Associated With (Holmium Laser Enucleation of the Prostate) HoLEP Procedures
A study testing HoLEP in people with Urologic Diseases and Prostate Obstruction, run by Northwestern University at 1 site in United States.
Trial summary
The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate. Read more about this study
- Who is it for?
- Ages 18 to 89 years, men only
- Conditions the study is for
- Urologic Diseases, Prostate Obstruction
- What is being tested?
- HoLEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 278 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2024to 30 Apr 2026
- Phase
- Interventional
- 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 18 to 89 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates
Who cannot join
- Prostates measurements over 200g
- Patients who lack decisional capacity
- Patients who are non-english speakers
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Laser Outcomes Associated With HoLEP Procedures
The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate.
Read the detailed description
There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2J 50Hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as > 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as >10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.
- Conditions
- Urologic Diseases, Prostate Obstruction
- Being tested
- HoLEP
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HoLEPProcedure or surgery
Patients will be randomized to one of the laser energy groups day of surgery.
| Study group | Role | What they receive |
|---|---|---|
| 2J 40hz Laser Energy | Experimental | Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz Receives: Procedure: HoLEP |
| 2J 50hz Laser Energy | Experimental | Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz Receives: Procedure: HoLEP |
| 2J 60hz Laser Energy | Experimental | Patients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz Receives: Procedure: HoLEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2024
- Study start4 Mar 2024
- Primary completion30 Aug 2025
- Study completion30 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 278 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amy Krambeck, Northwestern University
- Investigators
- Amy Krambeck, MD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06531473
- Sponsor's protocol ID
- STU00220458
- Status last verified
- Aug 2026
- First submitted
- 26 Jun 2024
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Laser Outcomes Associated With HoLEP Procedures
- ClinicalTrials.gov ID
- NCT06531473
- Acronym / sponsor ID
- STU00220458
- Conditions
- Urologic Diseases, Prostate Obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 278 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 4 Mar 2024 (actual)
- Primary completion
- 30 Aug 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 1 Aug 2024 (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.
The primary aim is to assess the impact of laser setting frequency and wattage during holmium laser enucleation of the prostate.
Detailed description
There is currently no gold-standard laser settings for HoLEP procedures. In the investigator's current high-volume practice, the following settings for enucleation are: 2J 50Hz. These settings are conventional settings, but there is no literature to prove optimal laser settings. The investigators hypothesizes that utilization of higher laser settings may be associated with a clinically significant (defined as > 10%) decrease in procedural time without any detrimental postoperative outcomes, and a utilization of lower laser settings may be associated with a clinically significant (defined as >10%) reduction in postoperative irritative voiding symptoms without any detrimental postoperative outcomes.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| 2J 40hz Laser Energy | Experimental | Procedure: HoLEPPatients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 40hz |
| 2J 50hz Laser Energy | Experimental | Procedure: HoLEPPatients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 50hz |
| 2J 60hz Laser Energy | Experimental | Procedure: HoLEPPatients will under go their Holmium Laser Enucleation procedure with the laser setting: 2J 60hz |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Males 18-89 who are undergoing HoLEP for the treatment of bothersome lower urinary tract symptoms, that are typically caused by enlarged prostates
Key exclusion criteria (3 listed)
- Prostates measurements over 200g
- Patients who lack decisional capacity
- Patients who are non-english speakers
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 |
|---|---|---|
| HoLEPPatients will be randomized to one of the laser energy groups day of surgery. | Procedure or surgery | 2J 40hz Laser Energy, 2J 50hz Laser Energy, 2J 60hz Laser Energy |
Primary outcome
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate.
Time frame: 2 years
Comparing operative outcomes between the 40 hz, 50 hz and 60 hz laser setting groups.
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 20 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Amy Krambeck, MD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HoLEP in people with Urologic Diseases and Prostate Obstruction, run by Northwestern University at 1 site in United States.
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 3 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 20 Aug 2026. 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 United States. 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?
Identifying Outcomes of 40 hz, 50 hz and 60 hz laser setting groups during Holmium Laser Enucleation of the Prostate. (time frame: 2 years). 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 20 Aug 2026.