BPH With Symptomatic Lower Urinary Tract SymptomsNCT07187180
Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
A study testing holmium laser and pulsed thulium laser in people with BPH With Symptomatic Lower Urinary Tract Symptoms and BPH With Urinary Obstruction, run by Smita De at 1 site in United States.
Trial summary
Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Read more about this study
- Who is it for?
- Ages 18 years and older, men onlyHealthy volunteers can take part
- Conditions the study is for
- BPH With Symptomatic Lower Urinary Tract Symptoms, BPH With Urinary Obstruction
- What is being tested?
- holmium laser and pulsed thulium laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jun 2025to Oct 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Understand and voluntarily sign an informed consent form.
- Patients must be males with a prostate, at least 18 years of age
- No prior prostate surgery
Who cannot join
- Unable/refuse to provide informed consent
- Prior prostate surgery
- Bladder stones that requiring lasering (small stone that can be removed whole is ok)
- Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Cleveland Clinic Main
Cleveland, Ohio, 44195
Iva Markovic, 216-636-9694, markovi@ccf.org
Smita De, MD, PhD, 216-445-4818, des@ccf.org
About this study
Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. "Virtual Basket™" mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.
Read the detailed description
Study Design This is a prospective randomized study to evaluate the differences in outcomes comparing the existing laser to a new laser among patients undergoing HoLEP. Patients will be evaluated prior to the procedure and at one follow-up time point. Patients will be randomized in equal numbers to each group. The primary outcome will be non-inferiority in hemostasis timing. Several secondary outcomes will be evaluated including enucleation time, active laser time, morcellation time, prostate volume, change in hemoglobin, applied total laser energy, enucleation efficacy (g/min), IPSS (International Prostate Symptom Score), QoL (Quality of Life), uroflowmetry, PVR (post-void residual), duration of catheterization.
- Being tested
- holmium laser, pulsed thulium laser
- Keywords
- BPH, Enlarged prostate, Thulio laser, Prostate enucleation, male urinary retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
holmium laserDevice
Prostate enucleation will holmium laser (control)
pulsed thulium laserDevice
experimental group - pulsed thulium laser prostate enucleation
| Study group | Role | What they receive |
|---|---|---|
| Control - Holmium | Active comparator | Holmium laser enucleation Receives: Device: holmium laser |
| Experimental - Thulio | Experimental | Thulio laser enucleation Receives: Device: pulsed thulium laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemostasis time
time required to get adequate hemostasis intraoperatively
Measured: During surgery
Secondary outcomes (13)
Blood Loss
Estimated blood loss (mL)
Measured: During surgery
Blood Loss
Change in hemoglobin (delta g/dL)
Measured: During surgery
Operative parameters
Enucleation time (minutes)
Measured: During surgery
Operative parameters
morcellation time (minutes)
Measured: During surgery
Operative parameters
enucleation efficiency (mL prostate)
Measured: During surgery
Laser parameters
Laser time (minutes)
Measured: During surgery
Laser parameters
laser energy (joules)
Measured: During surgery
Laser parameters
Fiber burn-back (cm)
Measured: During surgery
Subjective laser performance
Surgeon estimation of collateral tissue injury and overall performance (scale 1 minimum 10 maximum)
Measured: During surgery
Perioperative outcomes
volume of tissue removed (mL)
Measured: 0-5 days after surgey
Perioperative outcomes
catheter time (hours)
Measured: 0-5 days after surgery
Perioperative outcomes
length of stay (hours)
Measured: 0-5 days after surgery
Perioperative outcomes
operative complications
Measured: 30 days post op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2025
- Study start2 Jun 2025
- Primary completion11 May 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BPH With Symptomatic Lower Urinary Tract SymptomsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Smita De
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Smita De, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07187180
- Sponsor's protocol ID
- 25-209
- Status last verified
- Sep 2026
- First submitted
- 16 Jun 2025
- Last updated
- 30 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Clinical Efficacy of Thulio vs. Holmium Laser Enucleation of the Prostate
- ClinicalTrials.gov ID
- NCT07187180
- Acronym / sponsor ID
- 25-209
- Keywords
- BPH, Enlarged prostate, Thulio laser, Prostate enucleation, male urinary retention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Smita DeUniversity, hospital or other
- Study start
- 2 Jun 2025 (actual)
- Primary completion
- 11 May 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 22 Sep 2025 (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.
Many consider laser enucleation of the prostate the new 'gold standard' for the surgical treatment of benign prostatic hyperplasia (BPH) due to its excellent outcomes, high success rates, and long-term efficacy. Holmium laser enucleation of the prostate (HoLEP) was the earliest form of prostate enucleation and is recommended by the American Urological Association (AUA), along with thulium laser enucleation of the prostate (ThuLEP), as size-independent techniques for the management of BPH with fewer complications than transurethral resection of the prostate (TURP). Further development of laser technology has additionally led to enucleation using pulsed-modulated (e.g. "Virtual Basket™" mode or MOSES™ mode) holmium lasers as well as the thulium fiber laser.
Detailed description
Study Design This is a prospective randomized study to evaluate the differences in outcomes comparing the existing laser to a new laser among patients undergoing HoLEP. Patients will be evaluated prior to the procedure and at one follow-up time point. Patients will be randomized in equal numbers to each group. The primary outcome will be non-inferiority in hemostasis timing. Several secondary outcomes will be evaluated including enucleation time, active laser time, morcellation time, prostate volume, change in hemoglobin, applied total laser energy, enucleation efficacy (g/min), IPSS (International Prostate Symptom Score), QoL (Quality of Life), uroflowmetry, PVR (post-void residual), duration of catheterization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control - Holmium | Active comparator | Device: holmium laserHolmium laser enucleation |
| Experimental - Thulio | Experimental | Device: pulsed thulium laserThulio laser enucleation |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Understand and voluntarily sign an informed consent form.
- Patients must be males with a prostate, at least 18 years of age
- No prior prostate surgery
Key exclusion criteria (4 listed)
- Unable/refuse to provide informed consent
- Prior prostate surgery
- Bladder stones that requiring lasering (small stone that can be removed whole is ok)
- Unable to hold anticoagulants or antiplatelets per standard protocols for surgery and up to 1 week postop.
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 laserProstate enucleation will holmium laser (control) | Device | Control - Holmium |
| pulsed thulium laserexperimental group - pulsed thulium laser prostate enucleation | Device | Experimental - Thulio |
Primary outcome
Hemostasis time
Time frame: During surgery
time required to get adequate hemostasis intraoperatively
13 secondary outcomes
Blood Loss
Time frame: During surgery
Blood Loss
Time frame: During surgery
Operative parameters
Time frame: During surgery
Operative parameters
Time frame: During surgery
Operative parameters
Time frame: During surgery
Laser parameters
Time frame: During surgery
Laser parameters
Time frame: During surgery
Laser parameters
Time frame: During surgery
Subjective laser performance
Time frame: During surgery
Perioperative outcomes
Time frame: 0-5 days after surgey
Perioperative outcomes
Time frame: 0-5 days after surgery
Perioperative outcomes
Time frame: 0-5 days after surgery
Perioperative outcomes
Time frame: 30 days post op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Sep 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing holmium laser and pulsed thulium laser in people with BPH With Symptomatic Lower Urinary Tract Symptoms and BPH With Urinary Obstruction, run by Smita De 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 3 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: looking for participants now, as of the sponsor's last update on 30 Sep 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Iva Markovic (216-636-9694, markovi@ccf.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hemostasis time (time frame: During 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 30 Sep 2026.