Benign Prostatic HyperplasiaNCT07578428
Comparative Outcomes of Rezūm Versus EchoLaser for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe.
A study testing Rezūm Water Vapor Thermal Therapy and EchoLaser Transperineal Laser Ablation (TPLA) in people with Benign Prostatic Hyperplasia, run by Benha University.
Trial summary
This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Rezūm Water Vapor Thermal Therapy and EchoLaser Transperineal Laser Ablation (TPLA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2026to 1 May 2027
- 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 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 50 years or older.
- Diagnosis of symptomatic BPH with moderate-to-severe lower urinary tract symptoms, defined as an IPSS ≥ 12.
- Total prostate volume between 30 mL and 80 mL, confirmed via Transrectal Ultrasound (TRUS) or mpMRI.
- Presence of an enlarged, obstructing intravesical median lobe visualized via imaging or baseline cystoscopy.
- Peak urinary flow rate (Qmax) between 5 and 15 mL/s with a minimum voided volume of ≥ 125 mL.
Who cannot join
- Confirmed or suspected prostate cancer (e.g., PSA > 4.0 ng/mL without a subsequent negative prostate biopsy or MRI).
- History of prior surgical interventions for BPH (e.g., TURP, HOLEP, or other MISTs).
- Presence of urethral strictures, bladder neck contracture, or established neurogenic bladder dysfunction.
- Active urinary tract infection (UTI) or an episode of acute urinary retention requiring an indwelling catheter at the time of screening.
- Previous pelvic radiation therapy or severe pelvic trauma.
- Inability to safely pause anticoagulant/antiplatelet therapy per standard hospital perioperative protocols, if applicable.
About this study
Official title: Comparative Outcomes of Rezūm (Water Vapor Therapy) Versus EchoLaser (Transperineal Laser Ablation) for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe. A Prospective Randomized Comparative Study.
This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Participants will be randomized into two equal groups to receive either the Rezūm treatment or the EchoLaser treatment. The primary goal of the study is to evaluate the change in urinary symptoms over a 6-month period using the International Prostate Symptom Score (IPSS). The study will also assess how well each treatment improves urine flow, reduces the size of the prostate, preserves sexual function, and minimizes complications.
Read the detailed description
This is a single-center, prospective, randomized, active-controlled trial aiming to compare the clinical efficacy, safety profile, and functional outcomes of Rezūm water vapor thermal therapy versus EchoLaser transperineal laser ablation (TPLA). The trial focuses on symptomatic benign prostatic hyperplasia patients with a prostate volume between 30 mL and 80 mL and a confirmed enlarged intravesical median lobe. Eighty eligible male patients will be randomized 1:1 into two interventional groups: Group 1 (Rezūm Group): 40 patients will receive transurethral water vapor thermal therapy. The procedure involves targeted 9-second steam injections into the transition zone, alongside mandatory injections directed explicitly into the intravesical protruding median lobe to induce coagulative necrosis. Group 2 (EchoLaser TPLA Group): 40 patients will receive Transperineal Laser Ablation. Under real-time transrectal ultrasound (TRUS) guidance, optical fibers will deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe. Patients will undergo clinical, functional, and safety assessments at 1, 3, and 6 months post-operatively. Follow-up evaluations include uroflowmetry (peak urinary flow rate and post-void residual volume), symptom assessment via IPSS, and sexual health evaluation using IIEF-5 and MSHQ-EjD questionnaires. Morphological changes, specifically the reduction in Total Prostate Volume (TPV) and median lobe volume, will be confirmed using TRUS or mpMRI at the 6-month follow-up. Postoperative complications will be monitored and systematically graded using the Clavien-Dindo classification system.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Rezūm Water Vapor Thermal Therapy, EchoLaser Transperineal Laser Ablation (TPLA)
- Keywords
- Rezūm, EchoLaser
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rezūm Water Vapor Thermal TherapyDevice
Conducted via a transurethral approach. Standard 9-second thermal water vapor injections will be delivered into the transition zone, alongside mandatory, specifically angled injections directed explicitly into the intravesical protruding median lobe to induce targeted coagulative necrosis.
EchoLaser Transperineal Laser Ablation (TPLA)Device
Conducted via a transperineal approach. Under real-time transrectal ultrasound (TRUS) guidance, 21G introducer needles are placed, and optical fibers (300 µm) deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe.
| Study group | Role | What they receive |
|---|---|---|
| Rezūm Group | Active comparator | 40 patients receiving transurethral water vapor thermal therapy (Rezūm). The procedure involves targeted 9-second steam injections into the transition zone and the median lobe. Receives: Device: Rezūm Water Vapor Thermal Therapy |
| EchoLaser TPLA Group | Active comparator | 40 patients receiving Transperineal Laser Ablation utilizing the EchoLaser system. Optical fibers will deliver localized diode laser energy to the adenoma and the intravesical median lobe. Receives: Device: EchoLaser Transperineal Laser Ablation (TPLA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in International Prostate Symptom Score (IPSS)
The absolute and percentage difference in total IPSS, reflecting the primary subjective alleviation of lower urinary tract symptoms (LUTS).
Measured: Baseline to 6 months
Secondary outcomes (2)
Change in Peak Urinary Flow Rate (Qmax)
Objective change in peak urinary flow rate, measured in mL/s using uroflowmetry.
Measured: Baseline, 1 month, 3 months, and 6 months
Change in Post-Void Residual Volume (PVR)
Objective change in post-void residual volume, measured in mL via abdominal ultrasound.
Measured: Baseline, 1 month, 3 months, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Benha 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Attia, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07578428
- Sponsor's protocol ID
- MS5/1/2025
- Status last verified
- May 2026
- First submitted
- 5 May 2026
- Last updated
- 11 May 2026
- 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 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Outcomes of Rezūm (Water Vapor Therapy) Versus EchoLaser (Transperineal Laser Ablation) for Treatment of Benign Prostatic Hyperplasia With Enlarged Median Lobe. A Prospective Randomized Comparative Study.
- ClinicalTrials.gov ID
- NCT07578428
- Acronym / sponsor ID
- MS5/1/2025
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Rezūm, EchoLaser
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 May 2027 (estimated)
- First posted
- 11 May 2026 (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.
This study evaluates and compares two minimally invasive surgical therapies for treating men with benign prostatic hyperplasia (BPH) who specifically have an enlarged median lobe. The two treatments being compared are Rezūm (water vapor thermal therapy) and EchoLaser (transperineal laser ablation). Participants will be randomized into two equal groups to receive either the Rezūm treatment or the EchoLaser treatment. The primary goal of the study is to evaluate the change in urinary symptoms over a 6-month period using the International Prostate Symptom Score (IPSS). The study will also assess how well each treatment improves urine flow, reduces the size of the prostate, preserves sexual function, and minimizes complications.
Detailed description
This is a single-center, prospective, randomized, active-controlled trial aiming to compare the clinical efficacy, safety profile, and functional outcomes of Rezūm water vapor thermal therapy versus EchoLaser transperineal laser ablation (TPLA). The trial focuses on symptomatic benign prostatic hyperplasia patients with a prostate volume between 30 mL and 80 mL and a confirmed enlarged intravesical median lobe. Eighty eligible male patients will be randomized 1:1 into two interventional groups: Group 1 (Rezūm Group): 40 patients will receive transurethral water vapor thermal therapy. The procedure involves targeted 9-second steam injections into the transition zone, alongside mandatory injections directed explicitly into the intravesical protruding median lobe to induce coagulative necrosis. Group 2 (EchoLaser TPLA Group): 40 patients will receive Transperineal Laser Ablation. Under real-time transrectal ultrasound (TRUS) guidance, optical fibers will deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe. Patients will undergo clinical, functional, and safety assessments at 1, 3, and 6 months post-operatively. Follow-up evaluations include uroflowmetry (peak urinary flow rate and post-void residual volume), symptom assessment via IPSS, and sexual health evaluation using IIEF-5 and MSHQ-EjD questionnaires. Morphological changes, specifically the reduction in Total Prostate Volume (TPV) and median lobe volume, will be confirmed using TRUS or mpMRI at the 6-month follow-up. Postoperative complications will be monitored and systematically graded using the Clavien-Dindo classification system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rezūm Group | Active comparator | Device: Rezūm Water Vapor Thermal Therapy40 patients receiving transurethral water vapor thermal therapy (Rezūm). The procedure involves targeted 9-second steam injections into the transition zone and the median lobe. |
| EchoLaser TPLA Group | Active comparator | Device: EchoLaser Transperineal Laser Ablation (TPLA)40 patients receiving Transperineal Laser Ablation utilizing the EchoLaser system. Optical fibers will deliver localized diode laser energy to the adenoma and the intravesical median lobe. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male patients aged 50 years or older.
- Diagnosis of symptomatic BPH with moderate-to-severe lower urinary tract symptoms, defined as an IPSS ≥ 12.
- Total prostate volume between 30 mL and 80 mL, confirmed via Transrectal Ultrasound (TRUS) or mpMRI.
- Presence of an enlarged, obstructing intravesical median lobe visualized via imaging or baseline cystoscopy.
- Peak urinary flow rate (Qmax) between 5 and 15 mL/s with a minimum voided volume of ≥ 125 mL.
Key exclusion criteria (6 listed)
- Confirmed or suspected prostate cancer (e.g., PSA > 4.0 ng/mL without a subsequent negative prostate biopsy or MRI).
- History of prior surgical interventions for BPH (e.g., TURP, HOLEP, or other MISTs).
- Presence of urethral strictures, bladder neck contracture, or established neurogenic bladder dysfunction.
- Active urinary tract infection (UTI) or an episode of acute urinary retention requiring an indwelling catheter at the time of screening.
- Previous pelvic radiation therapy or severe pelvic trauma.
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 |
|---|---|---|
| Rezūm Water Vapor Thermal TherapyConducted via a transurethral approach. Standard 9-second thermal water vapor injections will be delivered into the transition zone, alongside mandatory, specifically angled injections directed explicitly into the intravesical protruding median lobe to induce targeted coagulative necrosis. | Device | Rezūm Group |
| EchoLaser Transperineal Laser Ablation (TPLA)Conducted via a transperineal approach. Under real-time transrectal ultrasound (TRUS) guidance, 21G introducer needles are placed, and optical fibers (300 µm) deliver continuous-wave diode laser energy (1064 nm) directly to the adenoma and the obstructing median lobe. | Device | EchoLaser TPLA Group |
Primary outcome
Change in International Prostate Symptom Score (IPSS)
Time frame: Baseline to 6 months
The absolute and percentage difference in total IPSS, reflecting the primary subjective alleviation of lower urinary tract symptoms (LUTS).
2 secondary outcomes
Change in Peak Urinary Flow Rate (Qmax)
Time frame: Baseline, 1 month, 3 months, and 6 months
Change in Post-Void Residual Volume (PVR)
Time frame: Baseline, 1 month, 3 months, and 6 months
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 11 May 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Rezūm Water Vapor Thermal Therapy and EchoLaser Transperineal Laser Ablation (TPLA) in people with Benign Prostatic Hyperplasia, run by Benha University.
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 5 inclusion and 6 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: opening soon, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Change in International Prostate Symptom Score (IPSS) (time frame: Baseline to 6 months). 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 11 May 2026.