Ejaculation-Preserving Versus Conventional Dual Wavelength Diode Laser Vaporization of the Prostate (EP-TUVP)

August 16, 2026 updated by: ALI KAMAL M. SAMI

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
119

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iraq
    • Kurdistan
      • Sulaymaniyah, Kurdistan, Iraq, 46001
        • Royal Hospital, Department of Urology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: conventional tuvp
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
Procedure: Conventional dual-wavelength diode laser vaporization of the prostate
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.
Experimental: Ejaculation-Preserving TUVP (EP-TUVP)
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.
Procedure: Ejaculation-preserving dual wavelength diode laser vaporization of the prostate
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 months after surgery

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Durability of integrate ejaculation preservation
Time Frame: 6 and 12 months after surgery
Proportion of participants reporting presence of any antegrade ejaculate, assessed as for the primary outcome, to test whether any benefit is sustained over time.
6 and 12 months after surgery
Change in international prostate symptom score IPSS
Time Frame: Baseline, 3, 6, and 12 months after surgery
IPSS total score, range 0 to 35, where higher scores indicate more severe lower urinary tract symptoms. Change from baseline is reported.
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
Single-item IPSS quality-of-life question, range 0 to 6, where higher scores indicate worse bother from urinary symptoms.
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
Maximum flow rate in mL/s measured by uroflowmetry, accepted only when voided volume was at least 150 mL. Higher values indicate better flow.
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
Post-void residual volume in mL measured by transabdominal ultrasound. Lower values indicate more complete bladder emptying.
Baseline, 3, 6, and 12 months after surgery
Change in prostate volume
Time Frame: Baseline, 3, 6, and 12 months after surgery
prostate volume in cc measured by transabdominal ultrasound, using the prolate, elipsoid formula with percentage reduction from baseline calculated
Baseline, 3, 6, and 12 months after surgery
Change in erectile function (IIEF-5)
Time Frame: Baseline, 3, 6, and 12 months after surgery
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
Baseline, 3, 6, and 12 months after surgery
Complications graded by Clavien-Dindo classification
Time Frame: From surgery to 12 months after surgery
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.
From surgery to 12 months after surgery
Patient global satisfaction
Time Frame: 3, 6, and 12 months after surgery
Patient-reported global satisfaction with the outcome of surgery on a 5-point scale, where 1 indicates very dissatisfied and 5 indicates very satisfied.
3, 6, and 12 months after surgery
Trifecta outcome
Time Frame: 12 months after surgery
Composite endpoint requiring all three of: IPSS below 8, complete pad independence, and preserved antegrade ejaculation.
12 months after surgery
Operative time, catheterization time and hospital stay
Time Frame: Day of surgery to hospital discharge, up to seven days
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.
Day of surgery to hospital discharge, up to seven days
Early post operative dysuria
Time Frame: Day 7 to 14 and 1month after surgery
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.
Day 7 to 14 and 1month after surgery
Re-treatment for benign prostatic obstruction
Time Frame: Up to 12 months after surgery
Proportion of participants requiring any further surgical intervention for benign prostatic obstruction.
Up to 12 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ALI KAMAL M. SAMI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 5, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 27, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 20, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UOS-COM-62-2024
  • UOS-COM-ETHICS-62 (Other Identifier: Ethics Committee, College of Medicine, University of Sulaimani)
  • UOS-CSD-REG-28 (Other Identifier: Clinical Sciences Department Scientific Committee, University of Sulaimani)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Beginning 6 months after publication of the primary results and ending 5 years thereafter.

IPD Sharing Access Criteria

Requests should be directed to the principal investigator and must include a methodologically sound proposal and a stated analysis objective. Data will be released after review of the proposal and completion of a data access agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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