Benign Prostatic HyperplasiaEP-TUVPNCT07777068
Ejaculation-Preserving Versus Conventional Dual Wavelength Diode Laser Vaporization of the Prostate
A study testing Conventional dual-wavelength diode laser vaporization of the prostate and Ejaculation-preserving dual wavelength diode laser vaporization of the prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms, run by ALI KAMAL M. SAMI at 1 site in Iraq.
Trial summary
Surgery to relieve urinary blockage caused by an enlarged prostate works well, but most men lose antegrade ejaculation afterwards, because semen passes backwards into the bladder instead of forwards. For sexually active men this is an important concern and a common reason for delaying or refusing surgery. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Track Symptoms, Bladder Outlet Obstruction
- What is being tested?
- Conventional dual-wavelength diode laser vaporization of the prostate and Ejaculation-preserving dual wavelength diode laser vaporization of the prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 119 participants
- Where
- 1 siteIraq
- Study dates
- 5 Oct 2024to 20 Jul 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, aged 50 years or older
- Lower urinary tract symptoms attributable to benign prostatic obstruction
- International Prostate Symptom Score of 16 or more
- Maximum urinary flow rate below 15 mL/s on a uroflowmetry study with a voided volume of at least 150 mL
- Prostate volume between 30 and 150 cc on transabdominal ultrasound
- Indication for surgery after failure of or intolerance to medical therapy
Show all 10Show fewer
- Preserved antegrade ejaculation at baseline
- Currently sexually active
- Willing and able to attend all scheduled follow-up visits
- Written informed consent, including specific consent to discussion and recording of ejaculatory function
Who cannot join
- Suspected or confirmed prostate cancer
- Prostate-specific antigen above the age-specific reference range without a benign explanation
- Neurogenic bladder
- Urethral stricture
- Bladder stones
- Previous prostatic or urethral surgery
- Absent antegrade ejaculation at baseline
- Erectile dysfunction sufficient to preclude sexual activity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ejaculation-Preserving Versus Conventional Dual-Wavelength Diode Laser Vaporization of the Prostate: A Randomized Comparative Study With 12-Month Follow up
Surgery to relieve urinary blockage caused by an enlarged prostate works well, but most men lose antegrade ejaculation afterwards, because semen passes backwards into the bladder instead of forwards. For sexually active men this is an important concern and a common reason for delaying or refusing surgery.
This study compared two ways of performing the same operation, laser vaporization of the prostate using a dual-wavelength diode laser. In the conventional technique, prostate tissue is removed from the bladder neck all the way to the verumontanum. In the ejaculation-preserving technique, the surgeon deliberately leaves a 10 mm rim of tissue at the bladder neck untouched, and another 10 mm of tissue just before the verumontanum untouched, while removing the blocking tissue in between. Everything else about the operation, including the laser settings, was the same.
Read more
Men were assigned to one of the two techniques by a computer-generated random sequence. They were assessed before surgery and again at 7 to 14 days, 1 month, 3 months, 6 months and 12 months after surgery.
The main question was how many men still had antegrade ejaculation 3 months after surgery. The study also compared urinary symptoms, urine flow rate, residual urine volume, prostate size, erectile function, complications and patient satisfaction, to find out whether preserving ejaculation costs anything in terms of relieving the urinary blockage.
Read the detailed description
BACKGROUND
Loss of antegrade ejaculation follows conventional transurethral resection or vaporization of the prostate in the majority of men. Two anatomical regions are considered central to this: the internal urethral sphincter at the bladder neck, which prevents retrograde passage of semen, and the paracollicular and supracollicular tissue around the verumontanum, which contributes to the emission phase. Techniques preserving one or both regions have been described across several endoscopic platforms, but evidence specific to the dual-wavelength diode laser is limited and follow-up in previous work has been short.
OBJECTIVE
To determine whether an ejaculation-preserving technique of dual-wavelength diode laser vaporization of the prostate preserves antegrade ejaculation without compromising relief of bladder outlet obstruction, and whether any benefit is durable to 12 months.
DESIGN
Prospective, randomized, single-centre comparative study conducted at the Department of Urology, Royal Hospital, Sulaymaniyah, Kurdistan Region, Iraq. Allocation followed a computer-generated random sequence, with assignments concealed in sequentially numbered opaque sealed envelopes opened after consent. Participants were not informed of their allocation. The operating surgeon was necessarily aware of allocation.
INTERVENTION
All procedures were performed by a single surgeon under spinal or general anaesthesia, using a 22 Fr continuous-flow laser cystoscope sheath with normal saline irrigation. Energy was delivered by a Ceralas dual-wavelength diode laser system (biolitec biomedical technology GmbH, Jena, Germany) emitting simultaneously at 980 nm and 1470 nm, through a bare-tip fibre in continuous-wave mode at a total power of 140 W. Laser wavelength, fibre type, emission mode and power setting were identical in both arms.
Conventional arm: vaporization proceeded from the bladder neck to the verumontanum in the standard fashion, including tissue at the bladder neck and immediately proximal to the verumontanum, until a wide channel was created.
Ejaculation-preserving arm: no vaporization was performed within 10 mm distal to the bladder neck, and no vaporization was performed within 10 mm proximal to the verumontanum. Between these two margins, the lateral lobes, median lobe and anterior tissue were vaporized to the same endpoint as in the conventional arm. Adherence to both margins was recorded prospectively in every case.
ASSESSMENTS
Participants were assessed at baseline and at day 7 to 14, 1 month, 3 months, 6 months and 12 months. Symptoms were quantified with the International Prostate Symptom Score and its quality-of-life item, and erectile function with the five-item International Index of Erectile Function. Uroflowmetry was accepted only with a voided volume of at least 150 mL. Post-void residual volume and prostate volume were measured by transabdominal ultrasound. Ejaculatory status was recorded as a binary patient-reported outcome: presence or absence of any antegrade ejaculate during sexual activity since the preceding visit. Complications were graded using the Clavien-Dindo classification.
ANALYSIS
Continuous variables were compared between arms with the Mann-Whitney U test and within arms against baseline with the Wilcoxon signed-rank test. Proportions were compared with the two-sided Fisher exact test, with risk differences reported using Newcombe hybrid-score 95 percent confidence intervals. No imputation was performed. Analysis was restricted to participants with complete records at every scheduled visit.
NOTE ON REGISTRATION
This trial was registered retrospectively. The protocol, including the primary endpoint, the secondary endpoints and the two 10 mm technical margins, was submitted to and registered by the Scientific Committee of the Department of Clinical Sciences, College of Medicine, University of Sulaimani (number 28, 25 February 2025) and approved by the Ethics Committee of the same institution (number 62, 2 March 2025). Public registry registration was not undertaken before enrolment because the requirement was not appreciated at the time. No outcome measures, eligibility criteria or analysis definitions were altered after the study began.
- Being tested
- Conventional dual-wavelength diode laser vaporization of the prostate, Ejaculation-preserving dual wavelength diode laser vaporization of the prostate
- Keywords
- ejaculation preservation, retrograde ejaculation, diode laser, laser vaporization of the prostate, dual wavelength, bladder neck preservation, ejaculatory hood, verumontanum, sexual function, BPH surgery
- Medical subject headings
- Prostatic Hyperplasia, Urinary Bladder Neck Obstruction, Retrograde Ejaculation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional dual-wavelength diode laser vaporization of the prostateProcedure or surgery
Transurethral vaporization of the prostate using a Ceralas dual-wavelength diode laser (biolitec biomedical technology GmbH, Jena, Germany) emitting simultaneously at 980 nm and 1470 nm, bare-tip fibre, continuous wave, total power 140 W, delivered through a 22 Fr continuous-flow laser cystoscope sheath with normal saline irrigation, under spinal or general anaesthesia. Adenoma was vaporized from the bladder neck to the verumontanum without preservation margins.
Ejaculation-preserving dual wavelength diode laser vaporization of the prostateProcedure or surgery
Identical equipment, laser settings and anaesthesia to the comparator intervention, with two preservation margins: no vaporization within 10 mm distal to the bladder neck and none within 10 mm proximal to the verumontanum. Adequacy of the mid-prostatic channel was confirmed endoscopically at the end of the procedure. Adherence to both margins was recorded prospectively for every case.
| Study group | Role | What they receive |
|---|---|---|
| conventional tuvp | Active comparator | Conventional dual-wavelength diode laser vaporization of the prostate. Vaporization proceeded from the bladder neck to the verumontanum in the standard fashion, with removal of obstructing adenoma including the tissue at the bladder neck and immediately proximal to the verumontanum, until a wide channel was created Receives: Procedure: Conventional dual-wavelength diode laser vaporization of the prostate |
| Ejaculation-Preserving TUVP (EP-TUVP) | Experimental | Ejaculation-preserving dual-wavelength diode laser vaporization of the prostate. No vaporization was performed within 10 mm distal to the bladder neck, preserving the circular muscle fibres of the internal sphincter, and no vaporization was performed within 10 mm proximal to the verumontanum, preserving the paracollicular and supracollicular tissue. Between these two margins, the lateral lobes, median lobe and anterior tissue were vaporized to the same endpoint as in the conventional arm. Laser settings were identical to the comparator arm. Receives: Procedure: Ejaculation-preserving dual wavelength diode laser vaporization of the prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Preservation of antegrade ejaculation
Proportion of participants reporting the presence of any antegrade ejaculate during sexual activity since the preceding visit. Recorded as a binary patient-reported outcome (present or absent). All participants had antegrade ejaculation at baseline as an eligibility requirement.
Measured: 3 months after surgery
Secondary outcomes (13)
Durability of integrate ejaculation preservation
Proportion of participants reporting presence of any antegrade ejaculate, assessed as for the primary outcome, to test whether any benefit is sustained over time.
Measured: 6 and 12 months after surgery
Change in international prostate symptom score IPSS
IPSS total score, range 0 to 35, where higher scores indicate more severe lower urinary tract symptoms. Change from baseline is reported.
Measured: Baseline, 3, 6, and 12 months after surgery
Change in IPSS quality of life score
Single-item IPSS quality-of-life question, range 0 to 6, where higher scores indicate worse bother from urinary symptoms.
Measured: Baseline, 3, 6, and 12 months after surgery
Change in maximum urinary flow rate (Qmax)
Maximum flow rate in mL/s measured by uroflowmetry, accepted only when voided volume was at least 150 mL. Higher values indicate better flow.
Measured: Baseline, 3, 6, and 12 months after surgery
Change in post-void residual urine volume
Post-void residual volume in mL measured by transabdominal ultrasound. Lower values indicate more complete bladder emptying.
Measured: Baseline, 3, 6, and 12 months after surgery
Change in prostate volume
prostate volume in cc measured by transabdominal ultrasound, using the prolate, elipsoid formula with percentage reduction from baseline calculated
Measured: Baseline, 3, 6, and 12 months after surgery
Change in erectile function (IIEF-5)
Five-item International Index of Erectile Function, range 5 to 25, where higher scores indicate better erectile function. Assessed as a control variable to distinguish ejaculatory from erectile outcomes. Face like, three, six, and 12 months after
Measured: Baseline, 3, 6, and 12 months after surgery
Complications graded by Clavien-Dindo classification
Clavien-Dindo grade recorded per participant, from grade I (any deviation from normal course) to grade V (death), including in-hospital and all follow-up intervals.
Measured: From surgery to 12 months after surgery
Patient global satisfaction
Patient-reported global satisfaction with the outcome of surgery on a 5-point scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
Measured: 3, 6, and 12 months after surgery
Trifecta outcome
Composite endpoint requiring all three of: IPSS below 8, complete pad independence, and preserved antegrade ejaculation.
Measured: 12 months after surgery
Operative time, catheterization time and hospital stay
Operative time in minutes measured from insertion to withdrawal of the cystoscope, duration of postoperative catheterisation in hours, and length of hospital stay in hours.
Measured: Day of surgery to hospital discharge, up to seven days
Early post operative dysuria
Dysuria severity on a visual analogue scale from 0 to 10, where higher scores indicate more severe dysuria, together with the duration of dysuria in days.
Measured: Day 7 to 14 and 1month after surgery
Re-treatment for benign prostatic obstruction
Proportion of participants requiring any further surgical intervention for benign prostatic obstruction.
Measured: Up to 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 posted20 Aug 2026
- Study start5 Oct 2024
- Primary completion27 Oct 2025
- Study completion20 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Model description
- Two parallel arms, each receiving a different technique of dual-wavelength diode laser vaporization of the prostate. Participants were assigned to one arm only, with no crossover.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 119 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALI KAMAL M. SAMI
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALI KAMAL M. SAMI, University of Sulaimani
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777068
- Sponsor's protocol ID
- UOS-COM-62-2024
- Other IDs
- UOS-COM-ETHICS-62, UOS-CSD-REG-28
- Acronym
- EP-TUVP
- Status last verified
- Aug 2026
- First submitted
- 16 Aug 2026
- Last updated
- 20 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the published results, including baseline characteristics, operative details, and all follow-up outcome measurements, will be made available to qualified investigators.
Publications
Emam A, Nabil Habib K, Teama K, Samir Y, Sadeq MM, Gamal MA. "Laser vaporization of the prostate: A comparative study between ejaculatory preserving and non-ejaculatory preserving technique". Arab J Urol. 2024 Jul 4;23(1):8-15. doi: 10.1080/20905998.2024.2375677. eCollection 2025.
PubMed 39776555Ramez M, Abolazm AE, El-Nahas AR. Ejaculatory-sparing transurethral prostatectomy: a meta-analysis of randomized controlled trials. Sex Med Rev. 2024 Sep 25;12(4):754-760. doi: 10.1093/sxmrev/qeae054.
PubMed 39138910Abolazm AE, El-Hefnawy AS, Laymon M, Shehab-El-Din AB, Elshal AM. Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized Trial. J Urol. 2020 Apr;203(4):792-801. doi: 10.1097/JU.0000000000000685. Epub 2019 Nov 25.
PubMed 31763948
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
- Ejaculation-Preserving Versus Conventional Dual-Wavelength Diode Laser Vaporization of the Prostate: A Randomized Comparative Study With 12-Month Follow up
- ClinicalTrials.gov ID
- NCT07777068
- Acronym / sponsor ID
- EP-TUVP / UOS-COM-62-2024
- Keywords
- ejaculation preservation, retrograde ejaculation, diode laser, laser vaporization of the prostate, dual wavelength, bladder neck preservation, ejaculatory hood, verumontanum
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 119 participants (actual)
- Lead sponsor
- ALI KAMAL M. SAMIUniversity, hospital or other
- Study start
- 5 Oct 2024 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 20 Jul 2026 (actual)
- First posted
- 20 Aug 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.
Surgery to relieve urinary blockage caused by an enlarged prostate works well, but most men lose antegrade ejaculation afterwards, because semen passes backwards into the bladder instead of forwards. For sexually active men this is an important concern and a common reason for delaying or refusing surgery.
This study compared two ways of performing the same operation, laser vaporization of the prostate using a dual-wavelength diode laser. In the conventional technique, prostate tissue is removed from the bladder neck all the way to the verumontanum. In the ejaculation-preserving technique, the surgeon deliberately leaves a 10 mm rim of tissue at the bladder neck untouched, and another 10 mm of tissue just before the verumontanum untouched, while removing the blocking tissue in between. Everything else about the operation, including the laser settings, was the same.
Men were assigned to one of the two techniques by a computer-generated random sequence. They were assessed before surgery and again at 7 to 14 days, 1 month, 3 months, 6 months and 12 months after surgery.
The main question was how many men still had antegrade ejaculation 3 months after surgery. The study also compared urinary symptoms, urine flow rate, residual urine volume, prostate size, erectile function, complications and patient satisfaction, to find out whether preserving ejaculation costs anything in terms of relieving the urinary blockage.
Detailed description
BACKGROUND
Loss of antegrade ejaculation follows conventional transurethral resection or vaporization of the prostate in the majority of men. Two anatomical regions are considered central to this: the internal urethral sphincter at the bladder neck, which prevents retrograde passage of semen, and the paracollicular and supracollicular tissue around the verumontanum, which contributes to the emission phase. Techniques preserving one or both regions have been described across several endoscopic platforms, but evidence specific to the dual-wavelength diode laser is limited and follow-up in previous work has been short.
OBJECTIVE
To determine whether an ejaculation-preserving technique of dual-wavelength diode laser vaporization of the prostate preserves antegrade ejaculation without compromising relief of bladder outlet obstruction, and whether any benefit is durable to 12 months.
DESIGN
Prospective, randomized, single-centre comparative study conducted at the Department of Urology, Royal Hospital, Sulaymaniyah, Kurdistan Region, Iraq. Allocation followed a computer-generated random sequence, with assignments concealed in sequentially numbered opaque sealed envelopes opened after consent. Participants were not informed of their allocation. The operating surgeon was necessarily aware of allocation.
INTERVENTION
All procedures were performed by a single surgeon under spinal or general anaesthesia, using a 22 Fr continuous-flow laser cystoscope sheath with normal saline irrigation. Energy was delivered by a Ceralas dual-wavelength diode laser system (biolitec biomedical technology GmbH, Jena, Germany) emitting simultaneously at 980 nm and 1470 nm, through a bare-tip fibre in continuous-wave mode at a total power of 140 W. Laser wavelength, fibre type, emission mode and power setting were identical in both arms.
Conventional arm: vaporization proceeded from the bladder neck to the verumontanum in the standard fashion, including tissue at the bladder neck and immediately proximal to the verumontanum, until a wide channel was created.
Ejaculation-preserving arm: no vaporization was performed within 10 mm distal to the bladder neck, and no vaporization was performed within 10 mm proximal to the verumontanum. Between these two margins, the lateral lobes, median lobe and anterior tissue were vaporized to the same endpoint as in the conventional arm. Adherence to both margins was recorded prospectively in every case.
ASSESSMENTS
Participants were assessed at baseline and at day 7 to 14, 1 month, 3 months, 6 months and 12 months. Symptoms were quantified with the International Prostate Symptom Score and its quality-of-life item, and erectile function with the five-item International Index of Erectile Function. Uroflowmetry was accepted only with a voided volume of at least 150 mL. Post-void residual volume and prostate volume were measured by transabdominal ultrasound. Ejaculatory status was recorded as a binary patient-reported outcome: presence or absence of any antegrade ejaculate during sexual activity since the preceding visit. Complications were graded using the Clavien-Dindo classification.
ANALYSIS
Continuous variables were compared between arms with the Mann-Whitney U test and within arms against baseline with the Wilcoxon signed-rank test. Proportions were compared with the two-sided Fisher exact test, with risk differences reported using Newcombe hybrid-score 95 percent confidence intervals. No imputation was performed. Analysis was restricted to participants with complete records at every scheduled visit.
NOTE ON REGISTRATION
This trial was registered retrospectively. The protocol, including the primary endpoint, the secondary endpoints and the two 10 mm technical margins, was submitted to and registered by the Scientific Committee of the Department of Clinical Sciences, College of Medicine, University of Sulaimani (number 28, 25 February 2025) and approved by the Ethics Committee of the same institution (number 62, 2 March 2025). Public registry registration was not undertaken before enrolment because the requirement was not appreciated at the time. No outcome measures, eligibility criteria or analysis definitions were altered after the study began.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Two parallel arms, each receiving a different technique of dual-wavelength diode laser vaporization of the prostate. Participants were assigned to one arm only, with no crossover.
| Arm | Type | Receives |
|---|---|---|
| conventional tuvp | Active comparator | Procedure: Conventional dual-wavelength diode laser vaporization of the prostateConventional dual-wavelength diode laser vaporization of the prostate. Vaporization proceeded from the bladder neck to the verumontanum in the standard fashion, with removal of obstructing adenoma including the tissue at the bladder neck and immediately proximal to the verumontanum, until a wide channel was created |
| Ejaculation-Preserving TUVP (EP-TUVP) | Experimental | Procedure: Ejaculation-preserving dual wavelength diode laser vaporization of the prostateEjaculation-preserving dual-wavelength diode laser vaporization of the prostate. No vaporization was performed within 10 mm distal to the bladder neck, preserving the circular muscle fibres of the internal sphincter, and no vaporization was performed within 10 mm proximal to the verumontanum, preserving the paracollicular and supracollicular tissue. Between these two margins, the lateral lobes, median lobe and anterior tissue were vaporized to the same endpoint as in the conventional arm. Laser settings were identical to the comparator arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male, aged 50 years or older
- Lower urinary tract symptoms attributable to benign prostatic obstruction
- International Prostate Symptom Score of 16 or more
- Maximum urinary flow rate below 15 mL/s on a uroflowmetry study with a voided volume of at least 150 mL
- Prostate volume between 30 and 150 cc on transabdominal ultrasound
Key exclusion criteria (8 listed)
- Suspected or confirmed prostate cancer
- Prostate-specific antigen above the age-specific reference range without a benign explanation
- Neurogenic bladder
- Urethral stricture
- Bladder stones
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 |
|---|---|---|
| Conventional dual-wavelength diode laser vaporization of the prostateTransurethral vaporization of the prostate using a Ceralas dual-wavelength diode laser (biolitec biomedical technology GmbH, Jena, Germany) emitting simultaneously at 980 nm and 1470 nm, bare-tip fibre, continuous wave, total power 140 W, delivered through a 22 Fr continuous-flow laser cystoscope sheath with normal saline irrigation, under spinal or general anaesthesia. Adenoma was vaporized from the bladder neck to the verumontanum without preservation margins. | Procedure or surgery | conventional tuvp |
| Ejaculation-preserving dual wavelength diode laser vaporization of the prostateIdentical equipment, laser settings and anaesthesia to the comparator intervention, with two preservation margins: no vaporization within 10 mm distal to the bladder neck and none within 10 mm proximal to the verumontanum. Adequacy of the mid-prostatic channel was confirmed endoscopically at the end of the procedure. Adherence to both margins was recorded prospectively for every case. | Procedure or surgery | Ejaculation-Preserving TUVP (EP-TUVP) |
Primary outcome
Preservation of antegrade ejaculation
Time frame: 3 months after surgery
Proportion of participants reporting the presence of any antegrade ejaculate during sexual activity since the preceding visit. Recorded as a binary patient-reported outcome (present or absent). All participants had antegrade ejaculation at baseline as an eligibility requirement.
13 secondary outcomes
Durability of integrate ejaculation preservation
Time frame: 6 and 12 months after surgery
Change in international prostate symptom score IPSS
Time frame: Baseline, 3, 6, and 12 months after surgery
Change in IPSS quality of life score
Time frame: Baseline, 3, 6, and 12 months after surgery
Change in maximum urinary flow rate (Qmax)
Time frame: Baseline, 3, 6, and 12 months after surgery
Change in post-void residual urine volume
Time frame: Baseline, 3, 6, and 12 months after surgery
Change in prostate volume
Time frame: Baseline, 3, 6, and 12 months after surgery
Change in erectile function (IIEF-5)
Time frame: Baseline, 3, 6, and 12 months after surgery
Complications graded by Clavien-Dindo classification
Time frame: From surgery to 12 months after surgery
Patient global satisfaction
Time frame: 3, 6, and 12 months after surgery
Trifecta outcome
Time frame: 12 months after surgery
Operative time, catheterization time and hospital stay
Time frame: Day of surgery to hospital discharge, up to seven days
Early post operative dysuria
Time frame: Day 7 to 14 and 1month after surgery
Re-treatment for benign prostatic obstruction
Time frame: Up to 12 months after surgery
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.
- Background: PubMed 39776555Emam A, Nabil Habib K, Teama K, Samir Y, Sadeq MM, Gamal MA. "Laser vaporization of the prostate: A comparative study between ejaculatory preserving and non-ejaculatory preserving technique". Arab J Urol. 2024 Jul 4;23(1):8-15. doi: 10.1080/20905998.2024.2375677. eCollection 2025.
- Background: PubMed 39138910Ramez M, Abolazm AE, El-Nahas AR. Ejaculatory-sparing transurethral prostatectomy: a meta-analysis of randomized controlled trials. Sex Med Rev. 2024 Sep 25;12(4):754-760. doi: 10.1093/sxmrev/qeae054.
- Background: PubMed 31763948Abolazm AE, El-Hefnawy AS, Laymon M, Shehab-El-Din AB, Elshal AM. Ejaculatory Hood Sparing versus Standard Laser Photoselective Vaporization of the Prostate: Sexual and Urodynamic Assessment through a Double Blinded, Randomized Trial. J Urol. 2020 Apr;203(4):792-801. doi: 10.1097/JU.0000000000000685. Epub 2019 Nov 25.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the published results, including baseline characteristics, operative details, and all follow-up outcome measurements, will be made available to qualified investigators.
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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 Conventional dual-wavelength diode laser vaporization of the prostate and Ejaculation-preserving dual wavelength diode laser vaporization of the prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Track Symptoms, run by ALI KAMAL M. SAMI at 1 site in Iraq.
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 10 inclusion and 8 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 Iraq. 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?
Preservation of antegrade ejaculation (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07777068, which also lists 3 linked publications.
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.