Benign Prostate Hypertrophy(BPH)NCT07566689
Holmium Laser Enucleation Of the Prostate Versus Water Vapor Therapy Of The Prostate on Sexual Function and Ejaculation
A study testing Holmium Laser Enucleation of the Prostate (HoLEP) and Water Vapor Thermal Therapy in people with Benign Prostate Hypertrophy(BPH), run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study aims to compare the effect of holmium laser enucleation of the prostate (HoLEP) versus water vapor therapy (Rezum) on sexual function and ejaculation in patients with benign prostatic hyperplasia (BPH). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostate Hypertrophy(BPH)
- What is being tested?
- Holmium Laser Enucleation of the Prostate (HoLEP) and Water Vapor Thermal Therapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Apr 2024to 3 Jan 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 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
- Diagnosed with benign prostatic hyperplasia (BPH)
- Presence of lower urinary tract symptoms (LUTS)
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≤ 15 mL/s
- Failure of medical therapy for BPH
- Sexually active and in a stable relationship
Who cannot join
- History of prostate cancer
- Prior prostate surgery
- Neurogenic bladder dysfunction
- Urethral stricture disease
- Active urinary tract infection
- Severe comorbidities contraindicating surgery
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative Study of the Effect of Holmium Laser Enucleation of the Prostate Versus Water Vapor Therapy of the Prostate on Sexual Function and Ejaculation
This study aims to compare the effect of holmium laser enucleation of the prostate (HoLEP) versus water vapor therapy (Rezum) on sexual function and ejaculation in patients with benign prostatic hyperplasia (BPH).
Benign prostatic hyperplasia is a common condition affecting aging men and may lead to lower urinary tract symptoms requiring surgical intervention. While both HoLEP and Rezum are effective minimally invasive treatments, their impact on sexual function, particularly ejaculation, remains an important concern.
Participants will be assigned to undergo either HoLEP or Rezum therapy. Sexual function and ejaculatory outcomes will be evaluated using validated questionnaires before and after treatment. The study aims to determine which modality provides better preservation of sexual function while maintaining clinical efficacy.
Read the detailed description
Benign prostatic hyperplasia (BPH) is a prevalent condition in aging males and is commonly associated with lower urinary tract symptoms (LUTS) that significantly affect quality of life. Surgical intervention is indicated in patients who fail medical therapy or present with complications.
Holmium laser enucleation of the prostate (HoLEP) is considered a gold standard surgical treatment for BPH, offering durable outcomes and effective removal of prostatic adenoma. However, it is frequently associated with postoperative retrograde ejaculation.
Water vapor thermal therapy (Rezum) is a minimally invasive treatment that uses convective water vapor energy to ablate prostatic tissue, with the potential advantage of preserving sexual and ejaculatory function.
This prospective comparative study aims to evaluate and compare the effects of HoLEP and Rezum on sexual function and ejaculatory outcomes. Eligible patients with BPH will be allocated to one of the two treatment groups according to the study protocol.
Primary outcomes include changes in sexual function and ejaculatory status assessed using validated questionnaires. Secondary outcomes include improvement in urinary symptoms and treatment-related complications.
The findings of this study may help guide clinical decision-making by balancing treatment efficacy with preservation of sexual function.
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Being tested
- Holmium Laser Enucleation of the Prostate (HoLEP), Water Vapor Thermal Therapy
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Holmium Laser Enucleation of the Prostate (HoLEP)Procedure or surgery
Holmium laser enucleation of the prostate is an endoscopic surgical procedure used for the treatment of benign prostatic hyperplasia. It involves complete enucleation of the prostatic adenoma using a holmium laser, followed by tissue morcellation.
Water Vapor Thermal TherapyProcedure or surgery
Water vapor thermal therapy (Rezum) is a minimally invasive procedure that uses convective radiofrequency-generated water vapor to ablate hyperplastic prostatic tissue, aiming to relieve lower urinary tract symptoms while preserving sexual function.
| Study group | Role | What they receive |
|---|---|---|
| HoLEP Group | Experimental | Patients undergoing holmium laser enucleation of the prostate for management of benign prostatic hyperplasia. Receives: Procedure: Holmium Laser Enucleation of the Prostate (HoLEP) |
| Rezum Group | Experimental | Patients undergoing water vapor thermal therapy (Rezum) for management of benign prostatic hyperplasia. Receives: Procedure: Water Vapor Thermal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Sexual Function
Change in sexual function assessed using validated patient-reported outcome measures (e.g., International Index of Erectile Function [IIEF] comparing baseline to post-treatment values.the IIEF score range from 5 to 25 with higher scores indicating better erectile function.
Measured: Baseline and 6 months after treatment
Change in ejaculatory function
Change in ejaculatory function assessed using validated patient-reported outcome measures (e.g., male sexual health questionnaire-Ejaculatory Dysfunction domain(MSHQ-EjD) comparing baseline to post-treatment values with higher scores indicating better ejaculatory function.
Measured: Baseline and 6 months after treatment
Secondary outcomes (1)
Change in Lower Urinary Tract Symptoms Score (IPSS)
Change in lower urinary tract symptoms severity assessed using the International Prostate Symptom Score (IPSS) comparing baseline to post-treatment values. score range from 0 to 35 with higher scores indicating worse symptoms.
Measured: Baseline and 6 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start3 Apr 2024
- Primary completion3 Dec 2025
- Study completion3 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate Hypertrophy(BPH)Studies of the same condition, open and under way.
- More trials run by Beni-Suef 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
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Abdallah, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07566689
- Sponsor's protocol ID
- FMBSUREC/03032024/Salem
- Status last verified
- Apr 2026
- First submitted
- 25 Apr 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative Study of the Effect of Holmium Laser Enucleation of the Prostate Versus Water Vapor Therapy of the Prostate on Sexual Function and Ejaculation
- ClinicalTrials.gov ID
- NCT07566689
- Acronym / sponsor ID
- FMBSUREC/03032024/Salem
- Conditions
- Benign Prostate Hypertrophy(BPH)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 3 Dec 2025 (actual)
- Study completion
- 3 Jan 2026 (actual)
- First posted
- 5 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 aims to compare the effect of holmium laser enucleation of the prostate (HoLEP) versus water vapor therapy (Rezum) on sexual function and ejaculation in patients with benign prostatic hyperplasia (BPH).
Benign prostatic hyperplasia is a common condition affecting aging men and may lead to lower urinary tract symptoms requiring surgical intervention. While both HoLEP and Rezum are effective minimally invasive treatments, their impact on sexual function, particularly ejaculation, remains an important concern.
Participants will be assigned to undergo either HoLEP or Rezum therapy. Sexual function and ejaculatory outcomes will be evaluated using validated questionnaires before and after treatment. The study aims to determine which modality provides better preservation of sexual function while maintaining clinical efficacy.
Detailed description
Benign prostatic hyperplasia (BPH) is a prevalent condition in aging males and is commonly associated with lower urinary tract symptoms (LUTS) that significantly affect quality of life. Surgical intervention is indicated in patients who fail medical therapy or present with complications.
Holmium laser enucleation of the prostate (HoLEP) is considered a gold standard surgical treatment for BPH, offering durable outcomes and effective removal of prostatic adenoma. However, it is frequently associated with postoperative retrograde ejaculation.
Water vapor thermal therapy (Rezum) is a minimally invasive treatment that uses convective water vapor energy to ablate prostatic tissue, with the potential advantage of preserving sexual and ejaculatory function.
This prospective comparative study aims to evaluate and compare the effects of HoLEP and Rezum on sexual function and ejaculatory outcomes. Eligible patients with BPH will be allocated to one of the two treatment groups according to the study protocol.
Primary outcomes include changes in sexual function and ejaculatory status assessed using validated questionnaires. Secondary outcomes include improvement in urinary symptoms and treatment-related complications.
The findings of this study may help guide clinical decision-making by balancing treatment efficacy with preservation of sexual function.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HoLEP Group | Experimental | Procedure: Holmium Laser Enucleation of the Prostate (HoLEP)Patients undergoing holmium laser enucleation of the prostate for management of benign prostatic hyperplasia. |
| Rezum Group | Experimental | Procedure: Water Vapor Thermal TherapyPatients undergoing water vapor thermal therapy (Rezum) for management of benign prostatic hyperplasia. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients aged 50 years or older
- Diagnosed with benign prostatic hyperplasia (BPH)
- Presence of lower urinary tract symptoms (LUTS)
- International Prostate Symptom Score (IPSS) ≥ 13
- Peak urinary flow rate (Qmax) ≤ 15 mL/s
Key exclusion criteria (6 listed)
- History of prostate cancer
- Prior prostate surgery
- Neurogenic bladder dysfunction
- Urethral stricture disease
- Active urinary tract infection
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 Laser Enucleation of the Prostate (HoLEP)Holmium laser enucleation of the prostate is an endoscopic surgical procedure used for the treatment of benign prostatic hyperplasia. It involves complete enucleation of the prostatic adenoma using a holmium laser, followed by tissue morcellation. | Procedure or surgery | HoLEP Group |
| Water Vapor Thermal TherapyWater vapor thermal therapy (Rezum) is a minimally invasive procedure that uses convective radiofrequency-generated water vapor to ablate hyperplastic prostatic tissue, aiming to relieve lower urinary tract symptoms while preserving sexual function. | Procedure or surgery | Rezum Group |
Primary outcome
Change in Sexual Function
Time frame: Baseline and 6 months after treatment
Change in sexual function assessed using validated patient-reported outcome measures (e.g., International Index of Erectile Function [IIEF] comparing baseline to post-treatment values.the IIEF score range from 5 to 25 with higher scores indicating better erectile function.
Change in ejaculatory function
Time frame: Baseline and 6 months after treatment
Change in ejaculatory function assessed using validated patient-reported outcome measures (e.g., male sexual health questionnaire-Ejaculatory Dysfunction domain(MSHQ-EjD) comparing baseline to post-treatment values with higher scores indicating better ejaculatory function.
1 secondary outcome
Change in Lower Urinary Tract Symptoms Score (IPSS)
Time frame: Baseline and 6 months after treatment
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 5 May 2026.
- Individual participant dataSharing planned: Yes
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Enucleation of the Prostate (HoLEP) and Water Vapor Thermal Therapy in people with Benign Prostate Hypertrophy(BPH), run by Beni-Suef University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 5 May 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 Egypt. 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?
Change in Sexual Function (time frame: Baseline and 6 months after treatment). The study lists 2 primary outcomes in all. 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 5 May 2026.