Benign Prostatic HyperplasiaEP-BTUEPNCT07629479
Ejaculation-Preserving Versus Standard Bipolar TUEP for BPH
A study testing Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate and Standard Bipolar Transurethral Enucleation of the Prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Benign Prostatic Obstruction
- What is being tested?
- Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate and Standard Bipolar Transurethral Enucleation of the Prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Sep 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 patients with lower urinary tract symptoms secondary to benign prostatic obstruction after failed medical treatment for at least 3 months.
- Sexually active patients with a continuous relationship with the same partner.
- International Prostate Symptom Score of 8 or greater.
- Transrectal ultrasound-estimated prostate size between 40 and 100 cc.
- Eligible for bipolar transurethral enucleation of the prostate.
- Ability to complete the required sexual and urinary function questionnaires.
- Ability to provide written informed consent.
Who cannot join
- Preoperative sexual dysfunction.
- Preoperative ejaculatory dysfunction.
- Diagnosis or suspicion of prostate cancer.
- Neurological disorders affecting lower urinary tract or sexual function.
- Detrusor hypocontractility.
- Catheter-dependent patients.
- Patients with bladder stones.
- Inability or refusal to provide informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Department of Urology- Beni-Suef University Hospitals
Banī Suwayf, Beni Suweif Governorate
About this study
Official title: Bipolar Transurethral Enucleation of the Prostate With Preservation of Ejaculation in Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Trial
This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.
Read the detailed description
Benign prostatic hyperplasia is a common cause of lower urinary tract symptoms in aging men. Surgical treatment is indicated when medical therapy fails or when symptoms remain bothersome. Bipolar transurethral enucleation of the prostate is an established endoscopic surgical technique for benign prostatic obstruction, but standard endoscopic prostate surgery may be associated with loss of antegrade ejaculation.
This study will evaluate whether an ejaculation-preserving modification of bipolar transurethral enucleation of the prostate can preserve ejaculatory function while maintaining effective relief of lower urinary tract symptoms. The ejaculation-preserving technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. The control group will undergo standard bipolar transurethral enucleation of the prostate.
Eligible sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment will be randomized in a 1:1 ratio to ejaculation-preserving B-TUEP or standard B-TUEP. Sexual and urinary outcomes will be assessed using validated questionnaires and objective urinary parameters. Follow-up assessments will include ejaculatory function, erectile function, International Prostate Symptom Score, post-void residual urine, uroflowmetry, perioperative complications, and need for retreatment.
- Being tested
- Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate, Standard Bipolar Transurethral Enucleation of the Prostate
- Keywords
- Bipolar transurethral enucleation of the prostate, B-TUEP, Ejaculation preservation, International Prostate Symptom Score
- Medical subject headings
- Prostatic Hyperplasia, Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ejaculation-Preserving Bipolar Transurethral Enucleation of the ProstateProcedure or surgery
Ejaculation-preserving bipolar transurethral enucleation of the prostate will be performed with preservation of the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum.
Standard Bipolar Transurethral Enucleation of the ProstateProcedure or surgery
Standard bipolar transurethral enucleation of the prostate will be performed according to the conventional surgical technique without preservation of the paracollicular tissue and the area approximately 1 cm proximal to the verumontanum.
| Study group | Role | What they receive |
|---|---|---|
| Ejaculation-Preserving B-TUEP | Experimental | Participants assigned to this arm will undergo ejaculation-preserving bipolar transurethral enucleation of the prostate. The technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. Receives: Procedure: Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate |
| Standard B-TUEP | Active comparator | Participants assigned to this arm will undergo standard bipolar transurethral enucleation of the prostate without the ejaculation-preserving modifications used in the experimental arm. Receives: Procedure: Standard Bipolar Transurethral Enucleation of the Prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months
Ejaculatory function will be assessed using the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form function score. The function score is based on three ejaculatory function items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The total function score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will be calculated as the 6-month postoperative score minus the baseline score. A smaller decrease or a positive change indicates better preservation of ejaculatory function.
Measured: Baseline and 6 months postoperatively
Secondary outcomes (5)
Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months
Ejaculatory bother will be assessed using the bother item of the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form. The bother score ranges from 0 to 5, with higher scores indicating greater bother related to ejaculatory dysfunction.
Measured: 6 months postoperatively
Preservation of Antegrade Ejaculation at 6 Months
The proportion of participants with preserved antegrade ejaculation at 6 months after surgery will be compared between the ejaculation-preserving B-TUEP group and the standard B-TUEP group. Preserved antegrade ejaculation will be defined as patient-reported antegrade seminal emission during orgasm after resumption of sexual activity. Participants reporting absent ejaculation, dry ejaculation, or retrograde ejaculation will be considered not to have preserved antegrade ejaculation.
Measured: 6 months postoperatively
Change in International Index of Erectile Function-5 Score From Baseline to 6 Months
Erectile function will be assessed using the International Index of Erectile Function-5 questionnaire. The total score ranges from 5 to 25, with higher scores indicating better erectile function. The outcome will be calculated as the 6-month postoperative score minus the baseline score.
Measured: Baseline and 6 months postoperatively
Change in International Prostate Symptom Score From Baseline to 6 Months
Lower urinary tract symptoms will be assessed using the International Prostate Symptom Score. The total score ranges from 0 to 35, with higher scores indicating more severe urinary symptoms. The outcome will be calculated as the 6-month postoperative score minus the baseline score.
Measured: Baseline and 6 months postoperatively
Change in Maximum Urinary Flow Rate From Baseline to 6 Months
Maximum urinary flow rate will be measured by uroflowmetry and reported in milliliters per second. The outcome will be calculated as the 6-month postoperative maximum urinary flow rate minus the baseline maximum urinary flow rate.
Measured: Baseline and 6 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2026
- Study start8 Sep 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- 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
- Model description
- Participants will be randomized in a 1:1 ratio to either ejaculation-preserving bipolar transurethral enucleation of the prostate or standard bipolar transurethral enucleation of the prostate.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Fathy Badawy, MD, Beni-Suef University
- Investigators
- Hany F Badawy, MD, Principal investigator, Faculty of medicine Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07629479
- Sponsor's protocol ID
- FMBSUREC07092025EjBTUEP
- Acronym
- EP-BTUEP
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 5 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study includes individual-level clinical, operative, urinary, and sexual function data from participants undergoing surgery for benign prostatic hyperplasia. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Transurethral Enucleation of the Prostate With Preservation of Ejaculation in Patients With Benign Prostatic Hyperplasia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07629479
- Acronym / sponsor ID
- EP-BTUEP / FMBSUREC07092025EjBTUEP
- Keywords
- Bipolar transurethral enucleation of the prostate, B-TUEP, Ejaculation preservation, International Prostate Symptom Score
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- 8 Sep 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 5 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective randomized controlled trial will compare ejaculation-preserving bipolar transurethral enucleation of the prostate with standard bipolar transurethral enucleation of the prostate in sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment. Participants will be randomly assigned to either ejaculation-preserving B-TUEP or standard B-TUEP. The study will evaluate preservation of ejaculatory function, erectile function, urinary symptom improvement, uroflowmetry outcomes, post-void residual urine, perioperative complications, and need for retreatment during follow-up.
Detailed description
Benign prostatic hyperplasia is a common cause of lower urinary tract symptoms in aging men. Surgical treatment is indicated when medical therapy fails or when symptoms remain bothersome. Bipolar transurethral enucleation of the prostate is an established endoscopic surgical technique for benign prostatic obstruction, but standard endoscopic prostate surgery may be associated with loss of antegrade ejaculation.
This study will evaluate whether an ejaculation-preserving modification of bipolar transurethral enucleation of the prostate can preserve ejaculatory function while maintaining effective relief of lower urinary tract symptoms. The ejaculation-preserving technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. The control group will undergo standard bipolar transurethral enucleation of the prostate.
Eligible sexually active men with benign prostatic hyperplasia and lower urinary tract symptoms after failed medical treatment will be randomized in a 1:1 ratio to ejaculation-preserving B-TUEP or standard B-TUEP. Sexual and urinary outcomes will be assessed using validated questionnaires and objective urinary parameters. Follow-up assessments will include ejaculatory function, erectile function, International Prostate Symptom Score, post-void residual urine, uroflowmetry, perioperative complications, and need for retreatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized in a 1:1 ratio to either ejaculation-preserving bipolar transurethral enucleation of the prostate or standard bipolar transurethral enucleation of the prostate.
| Arm | Type | Receives |
|---|---|---|
| Ejaculation-Preserving B-TUEP | Experimental | Procedure: Ejaculation-Preserving Bipolar Transurethral Enucleation of the ProstateParticipants assigned to this arm will undergo ejaculation-preserving bipolar transurethral enucleation of the prostate. The technique will preserve the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. |
| Standard B-TUEP | Active comparator | Procedure: Standard Bipolar Transurethral Enucleation of the ProstateParticipants assigned to this arm will undergo standard bipolar transurethral enucleation of the prostate without the ejaculation-preserving modifications used in the experimental arm. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male patients with lower urinary tract symptoms secondary to benign prostatic obstruction after failed medical treatment for at least 3 months.
- Sexually active patients with a continuous relationship with the same partner.
- International Prostate Symptom Score of 8 or greater.
- Transrectal ultrasound-estimated prostate size between 40 and 100 cc.
- Eligible for bipolar transurethral enucleation of the prostate.
Key exclusion criteria (8 listed)
- Preoperative sexual dysfunction.
- Preoperative ejaculatory dysfunction.
- Diagnosis or suspicion of prostate cancer.
- Neurological disorders affecting lower urinary tract or sexual function.
- Detrusor hypocontractility.
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 |
|---|---|---|
| Ejaculation-Preserving Bipolar Transurethral Enucleation of the ProstateEjaculation-preserving bipolar transurethral enucleation of the prostate will be performed with preservation of the paracollicular tissue, the area approximately 1 cm proximal to the verumontanum, and bladder neck fibers, while avoiding deep enucleation behind the verumontanum. | Procedure or surgery | Ejaculation-Preserving B-TUEP |
| Standard Bipolar Transurethral Enucleation of the ProstateStandard bipolar transurethral enucleation of the prostate will be performed according to the conventional surgical technique without preservation of the paracollicular tissue and the area approximately 1 cm proximal to the verumontanum. | Procedure or surgery | Standard B-TUEP |
Primary outcome
Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months
Time frame: Baseline and 6 months postoperatively
Ejaculatory function will be assessed using the Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form function score. The function score is based on three ejaculatory function items assessing ejaculation frequency, ejaculation force, and ejaculation volume. The total function score ranges from 1 to 15, with higher scores indicating better ejaculatory function. The outcome will be calculated as the 6-month postoperative score minus the baseline score. A smaller decrease or a positive change indicates better preservation of ejaculatory function.
5 secondary outcomes
Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Bother Score at 6 Months
Time frame: 6 months postoperatively
Preservation of Antegrade Ejaculation at 6 Months
Time frame: 6 months postoperatively
Change in International Index of Erectile Function-5 Score From Baseline to 6 Months
Time frame: Baseline and 6 months postoperatively
Change in International Prostate Symptom Score From Baseline to 6 Months
Time frame: Baseline and 6 months postoperatively
Change in Maximum Urinary Flow Rate From Baseline to 6 Months
Time frame: Baseline and 6 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study includes individual-level clinical, operative, urinary, and sexual function data from participants undergoing surgery for benign prostatic hyperplasia. Only aggregated, de-identified study results will be reported in publications or presentations. Any future data sharing request will require approval from the Research Ethics Committee, Faculty of Medicine, Beni-Suef University.
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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.
Hany F Badawy, MD principal investigator
Faculty of medicine Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ejaculation-Preserving Bipolar Transurethral Enucleation of the Prostate and Standard Bipolar Transurethral Enucleation of the Prostate in people with Benign Prostatic Hyperplasia and Lower Urinary Tract Symptoms, run by Beni-Suef 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 8 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: looking for participants now, as of the sponsor's last update on 5 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hany F Badawy, MD (+201149525028, HANYFATHY86@GMAIL.COM), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Male Sexual Health Questionnaire Ejaculatory Dysfunction Short Form Function Score From Baseline to 6 Months (time frame: Baseline and 6 months postoperatively). 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 5 Jun 2026.