Ejaculation-Preserving Versus Conventional Dual Wavelength Diode Laser Vaporization of the Prostate

NCT07777068 | Completed

• 3 other identifiers: UOS-COM-62-2024UOS-COM-ETHICS-62UOS-CSD-REG-28
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Benign Prostatic Hyperplasia; Lower Urinary Track Symptoms; Bladder Outlet Obstruction

Keywords

ejaculation preservation; retrograde ejaculation; diode laser; laser vaporization of the prostate; dual wavelength; bladder neck preservation; ejaculatory hood; verumontanum; sexual function; BPH surgery

Outcome Measures

Primary Outcomes (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.

  3 months after surgery

Secondary Outcomes (13)

• Durability of integrate ejaculation preservation

  6 and 12 months after surgery

• Change in international prostate symptom score IPSS

  Baseline, 3, 6, and 12 months after surgery

• Change in IPSS quality of life score

  Baseline, 3, 6, and 12 months after surgery

• Change in maximum urinary flow rate (Qmax)

  Baseline, 3, 6, and 12 months after surgery

• Change in post-void residual urine volume

  Baseline, 3, 6, and 12 months after surgery

Study Arms (2)

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

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.

Procedure: Ejaculation-preserving dual wavelength diode laser vaporization of the prostate

Interventions

Conventional dual-wavelength diode laser vaporization of the prostate PROCEDURE

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.

conventional tuvp

Ejaculation-preserving dual wavelength diode laser vaporization of the prostate PROCEDURE

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.

Ejaculation-Preserving TUVP (EP-TUVP)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALI KAMAL M. SAMI: lead

Study Sites (1)

Royal Hospital, Department of Urology

Sulaymaniyah, Kurdistan, 46001, Iraq

Location

Related Publications (3)

• 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.

  PMID: 39776555 BACKGROUND

• 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.

  PMID: 39138910 BACKGROUND

• 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.

  PMID: 31763948 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Bladder Neck Obstruction; Retrograde Ejaculation

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urethral Obstruction; Urethral Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urinary Bladder Diseases; Ejaculatory Dysfunction; Sexual Dysfunction, Physiological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were not informed of their allocation. The operating surgeon could not be masked to the surgical technique. Outcome data were self-completed by participants or obtained by objective measurement
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant Urological Surgeon

Model Details: 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.

Study Record Dates

• First Submitted: August 16, 2026
• First Posted: August 20, 2026
• Study Start: October 5, 2024
• Primary Completion: October 27, 2025
• Study Completion: July 20, 2026
• Last Updated: August 20, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after publication of the primary results and ending 5 years thereafter.
• 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.

Locations

IR (1)