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.
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
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- 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.
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.
- Conditions
- Ejaculatory Dysfunction, BPH
- 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 group | Role | What they receive |
|---|---|---|
| Group 1 | Active comparator | Not described Receives: Procedure: Ejaculatory Preserving Transurethral resection of prostate |
| Group 2 | Active comparator | Not 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.
Preservation of Ejaculation
The number of patients who can ejaculate after TURP
Measured: 6 months
Secondary outcomes (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.
- First posted22 Jun 2023
- Study start1 Jul 2023
- Primary completion1 Jan 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ejaculatory DysfunctionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Sabri Mahmoud, Sohag University
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes and Efficacy of Ejaculatory Preserving Transurethral Resection of Prostate
- ClinicalTrials.gov ID
- NCT05914519
- Acronym / sponsor ID
- Soh-Med-23-06-02MD
- Conditions
- Ejaculatory Dysfunction, BPH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Posted 6 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the outcomes and efficacy of ejaculatory preserving TURP in terms of voiding, erectile function, and ejaculation.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 | Active comparator | Procedure: Ejaculatory Preserving Transurethral resection of prostate |
| Group 2 | Active comparator | Procedure: Standard Transurethral Resection of prostate |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (7 listed)
- History of prostate or urethral surgery.
- Neurogenic bladder.
- UTI.
- Urethral stricture disease.
- prostate cancer.
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 |
|---|---|---|
| Ejaculatory Preserving Transurethral resection of prostateAlso: EpTURPTransurethral resection of prostate with preservation of 1cm safety area above verumontanum and without paracollicular digging | Procedure or surgery | Group 1 |
| Standard Transurethral Resection of prostateAlso: Standard TURPTransurethral resection of prostate including whole adenoma till the capsule. | Procedure or surgery | Group 2 |
Primary outcome
Preservation of Ejaculation
Time frame: 6 months
The number of patients who can ejaculate after TURP
1 secondary outcome
Maximum Flow Rate (Qmax)
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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 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.