AzTrials
AzTrials

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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

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
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

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.

Iraq1 site
  • Royal Hospital, Department of Urology

    Sulaymaniyah, Kurdistan, 46001

Other trials in Iraq

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 groups in NCT07777068
Study groupRoleWhat they receive
conventional tuvpActive comparatorConventional 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)ExperimentalEjaculation-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.

  1. 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)
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Trifecta outcome

    Composite endpoint requiring all three of: IPSS below 8, complete pad independence, and preserved antegrade ejaculation.

    Measured: 12 months after surgery

  11. 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

  12. 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

  13. 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.

  1. First posted20 Aug 2026
  2. Study start5 Oct 2024
  3. Primary completion27 Oct 2025
  4. Study completion20 Jul 2026

Resources

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)
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 39776555
  • Ramez 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 39138910
  • Abolazm 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

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in