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Ejaculatory DysfunctionNCT05914519

Outcomes and Efficacy of Ejaculatory Preserving Transurethral Resection of Prostate

A study testing Ejaculatory Preserving Transurethral resection of prostate and Standard Transurethral Resection of prostate in people with Ejaculatory Dysfunction and BPH, run by Sohag University at 1 site in Egypt.

Completed

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

Official record
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Trial summary

The purpose of this study is to assess the outcomes and efficacy of ejaculatory preserving TURP in terms of voiding, erectile function, and ejaculation. Read more about this study

Who is it for?
Ages 45 years and older, men onlyHealthy volunteers can take part
Conditions the study is for
Ejaculatory Dysfunction, BPH
What is being tested?
Ejaculatory Preserving Transurethral resection of prostate and Standard Transurethral Resection of prostate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
1 siteEgypt
Study dates
1 Jul 2023to 1 Jun 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 45 years and older
  • Men only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Adult patient > 45 years old.
  • Drug refractory urinary retention.
  • Prostate volume range: 20-60 mL.
  • IPSS > 19 after the medical therapy failure.
  • Qmax < 10 mL/s.
  • PSA < 4 ng/mL.
  • Active and healthy sexual life.

Who cannot join

  • History of prostate or urethral surgery.
  • Neurogenic bladder.
  • UTI.
  • Urethral stricture disease.
  • prostate cancer.
  • Bleeding diathesis.
  • Capsular or bladder perforation during surgery.

Trial locations and contacts

1 site in 1 country.

Egypt1 site
  • Sohag University

    Sohag, Sohag Governorate

Other trials in Egypt

About this study

The purpose of this study is to assess the outcomes and efficacy of ejaculatory preserving TURP in terms of voiding, erectile function, and ejaculation.

Read the detailed description

The prostatic gland plays a central role in andrology. It is involved both in fertility and in sexuality with a major role in ejaculation and possibly in orgasm. This could explain the association between the andrological symptoms and prostatic disorders.

The prevalence of Benign Prostatic Hyperplasia (BPH) is approximately 50% for men in their fifties and reaches up to 80% for men over 80 years of age, representing one of the most common diseases affecting males, with potentially significant impact on their quality of life.

It is estimated that around half of men suffering severe or medical treatment unresponsive lower urinary tract symptoms (LUTS) will be offered a surgical procedure to relieve benign prostatic obstruction (BPO).

Despite continuing development of new minimally invasive surgical methods, transurethral resection of the prostate (TURP) still remains the gold standard surgical treatment for LUTS due to BPH.

Although it is benign, this disease has been shown to have a negative impact on the patient's health-related quality of life (HRQL), marked by obstructive and irritative LUTS.

As BPH in most cases is not a life-threatening condition, the main outcomes of its treatment are not only the improvement in LUTS and functional parameters but also quality of life after surgery.

Whilst efficacy of the conventional TURP is proven, a common potentially bothersome side effect, the retrograde ejaculation (RE) which occurs in 65-90% of patients undergoing TURP.

It has been reported that ablative techniques like TURP and recent laser procedures including holmium, thulium and greenlight cause similar rates of ejaculatory dysfunction, occurring in almost three out of four to five men.

For decades, men have been counseled to expect dry orgasm after TURP because of the retrograde flow of semen as a result of bladder neck disruption.

Erectile dysfunction and Ejaculatory dysfunction (EjD) can have a substantial deleterious effect on the Quality of life (QoL) of men who have previously maintained regular sexual activity, inducing significantly increased levels of anxiety and depression.

More recently, a better understanding of ejaculation physiology has enabled the emergence of modified surgical techniques with the aim of preserving antegrade ejaculation.

The key point of standard TURP is resecting the tissues enveloped in the prostatic capsule and the bladder neck, while protecting the urethral tissues below the verumontanum.

The bladder neck plays a significant role in reproduction. For men, bladder neck closure facilitates anterograde ejaculation. It actively contracts the bladder neck during ejaculation through a rich noradrenergic innervation by sympathetic nerves.

Vernet et al. showed that contraction of the bladder neck was not important for anterograde ejaculation. Using endorectal ultrasound videos performed during masturbation in 30 men, it was possible to visualize the bladder neck, the prostate, and the bulbar urethra during ejaculation. They observed that during ejaculation, the verumontanum underwent a slight caudal shift, momentarily making contact with the opposite urethral wall and sperm emitted from the ejaculatory ducts was directed distally by contractions of the external sphincter coordinated with contractions of the bulbar urethra, thus demonstrating the importance of the muscular tissue around the verumontanum and particularly its proximal part. They described this area as a "high-pressure ejaculatory area". The closure of the bladder neck did not seem to play a role in this mechanism. As a result, one can conclude that as long as the tissues around the verumontanum are not injured, ejaculation should still occur even with a well-open bladder neck.

Recently, together with a better understanding of the mechanisms of ejaculation, a greater importance has been given to the impact of dry ejaculation on patients' QoL. A balance between symptomatic improvement in LUTS and preservation of sexual function needs to be addressed for men seeking surgical treatment.

Modifications based on Supramontanal sparing hypothesis have reported favorable outcomes to as high as 92%.

Although preservation of bladder neck structures is often associated with preservation of antegrade ejaculation, the current modern approach is the preservation of the precollicular and para-collicular tissue in the area where the ejaculatory ducts emerge near the verumontanum in the distal apical tissue in laser, aquablation, and bipolar electrosurgical prostatectomy techniques.

Being tested
Ejaculatory Preserving Transurethral resection of prostate, Standard Transurethral Resection of prostate
Medical subject headings
Ejaculatory Dysfunction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ejaculatory Preserving Transurethral resection of prostateProcedure or surgery

    Also called EpTURP

    Transurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging

  • Standard Transurethral Resection of prostateProcedure or surgery

    Also called Standard TURP

    Transurethral resection of prostate including whole adenoma till the capsule.

Study groups in NCT05914519
Study groupRoleWhat they receive
Group 1Active comparatorNot described
Receives: Procedure: Ejaculatory Preserving Transurethral resection of prostate
Group 2Active comparatorNot described
Receives: Procedure: Standard Transurethral Resection of prostate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Preservation of Ejaculation

    The number of patients who can ejaculate after TURP

    Measured: 6 months

Secondary outcomes (1)
  1. Maximum Flow Rate (Qmax)

    The maximum flow of urine measured by Uroflowmetry

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Jun 2023
  2. Study start1 Jul 2023
  3. Primary completion1 Jan 2025
  4. Study completion1 Jun 2025

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05914519
Sponsor's protocol ID
Soh-Med-23-06-02MD
Status last verified
Dec 2025
First submitted
12 Jun 2023
Last updated
6 Jan 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ejaculatory Preserving Transurethral resection of prostate and Standard Transurethral Resection of prostate in people with Ejaculatory Dysfunction and BPH, run by Sohag 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 7 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 6 Jan 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?

Yes. Results are posted in the registry (first posted 6 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Ejaculation (time frame: 6 months). 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 6 Jan 2026.

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