BPHProstateNCT05330156
Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study
A study testing Transurethral resection of the prostate and transurethral enucleation of prostate in people with BPH, run by Assiut University at 1 site in Egypt.
Trial summary
TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- BPH
- What is being tested?
- Transurethral resection of the prostate and transurethral enucleation of prostate
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Apr 2022to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- -Patients aging from 50 to 80 years old who are diagnosed with clinical symptomatic BPH.
- The patients have clear indi¬cation for endoscopic surgery (according to the guidelines).
- Clinically fit patients for surgery.
- Signed an informed consent.
Who cannot join
- Prostate cancer Previous urethral or prostate surgery Neurogenic bladder Urethral stricture Poor general condition of the patient
Trial locations and contacts
1 site in 1 country.
About this study
TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator.
Read the detailed description
Transurethral resection of the prostate (TURP) was first done in the 1920s. Since then, TURP has been considered as the gold standard treatment for BPH . However, its relatively high complication rate and postoperative recurrence necessitates further modification in the surgery technique .The resected adenomas have been reported to recur in up to 15% of cases that need a repeat surgical intervention, even by experienced surgeons in high-volume centers .
Before the era of TURP, simple open prostatectomy was the mainstay of surgical therapy. However, open simple prostatectomy has high risk of considerable intraoperative bleeding requiring transfusion. The lower abdominal incision done in open prostatectomy may result in significant postoperative pain, an extended recovery period and longer hospital stay, with greater morbidity and a perioperative mortality rate of 0.2%. In addition, TURP for large prostatic adenomas causes significantly much more bleeding with clot retention as compared to simple open prostatectomy, it also need a longer operative time, which leads to increased risk of TUR syndrome with subsequent morbidity . A new technique in which transurethral enucleation and resection of the prostate (TUERP) was developed and adopted to replicate the open enucleation of prostatic adenomas in an endoscopic way. This will combine the benefits of complete prostate enucleation in a minimally invasive technique . prostate enucleation by laser currently used as minimally invasive and save alternative to TURP, but still has not been widely accepted for some reasons, including high cost and prolonged learning curve.
TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator
- Conditions
- BPH
- Being tested
- Transurethral resection of the prostate, transurethral enucleation of prostate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transurethral resection of the prostateProcedure or surgery
- After an initial cysto-urethroscopy assessment done, Transurethral resection of the prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.
transurethral enucleation of prostateProcedure or surgery
After an initial cysto-urethroscopy assessment done, transurethral enucleation of prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia.
| Study group | Role | What they receive |
|---|---|---|
| Transurethral resection of the prostate group (TURP). | Active comparator | the 1st group of patients will undergone Transurethral resection of the prostate for treatment of BPH Receives: Procedure: Transurethral resection of the prostate |
| transurethral enucleation of prostate group (TUEP) | Active comparator | the 2nd group of patients will undergone Transurethral enucleation of the prostate for treatment of BPH Receives: Procedure: transurethral enucleation of prostate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of operation
time used for resection or enucleation and resection of the prostate
Measured: intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2022
- Study start30 Apr 2022 (estimated)
- Primary completion30 Mar 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BPHStudies of the same condition, open and under way.
- More trials run by Assiut 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
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AHMED FARAHAT HASSAN, Assiut University
- Investigators
- MOHAMED F ABBAS, MD, Principal investigator, AUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05330156
- Sponsor's protocol ID
- TURP
- Acronym
- Prostate
- Status last verified
- Apr 2022
- First submitted
- 28 Mar 2022
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mostafa MM, Ibrahim AF, Moeen AM, Elgammal MA, El-Azab AS, Faragallah MA. Bipolar resection versus enucleation of the prostate in management of benign prostatic hyperplasia patients with large-sized prostates: a prospective randomized controlled clinical trial. BMC Urol. 2026 Jan 24;26(1):52. doi: 10.1186/s12894-025-02004-1.
PubMed 41580733
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Resection Versus Transurethral Enucleation of the Prostate: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05330156
- Acronym / sponsor ID
- Prostate / TURP
- Conditions
- BPH
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Apr 2022 (estimated)
- Primary completion
- 30 Mar 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 15 Apr 2022 (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.
TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator.
Detailed description
Transurethral resection of the prostate (TURP) was first done in the 1920s. Since then, TURP has been considered as the gold standard treatment for BPH . However, its relatively high complication rate and postoperative recurrence necessitates further modification in the surgery technique .The resected adenomas have been reported to recur in up to 15% of cases that need a repeat surgical intervention, even by experienced surgeons in high-volume centers .
Before the era of TURP, simple open prostatectomy was the mainstay of surgical therapy. However, open simple prostatectomy has high risk of considerable intraoperative bleeding requiring transfusion. The lower abdominal incision done in open prostatectomy may result in significant postoperative pain, an extended recovery period and longer hospital stay, with greater morbidity and a perioperative mortality rate of 0.2%. In addition, TURP for large prostatic adenomas causes significantly much more bleeding with clot retention as compared to simple open prostatectomy, it also need a longer operative time, which leads to increased risk of TUR syndrome with subsequent morbidity . A new technique in which transurethral enucleation and resection of the prostate (TUERP) was developed and adopted to replicate the open enucleation of prostatic adenomas in an endoscopic way. This will combine the benefits of complete prostate enucleation in a minimally invasive technique . prostate enucleation by laser currently used as minimally invasive and save alternative to TURP, but still has not been widely accepted for some reasons, including high cost and prolonged learning curve.
TUERP technique could be used in prostates of all sizes with the same safety and efficacy "size independent procedure" . TUERP could be performed using the bipolar system only ,with or without the use of morcellator
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transurethral resection of the prostate group (TURP). | Active comparator | Procedure: Transurethral resection of the prostatethe 1st group of patients will undergone Transurethral resection of the prostate for treatment of BPH |
| transurethral enucleation of prostate group (TUEP) | Active comparator | Procedure: transurethral enucleation of prostatethe 2nd group of patients will undergone Transurethral enucleation of the prostate for treatment of BPH |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- -Patients aging from 50 to 80 years old who are diagnosed with clinical symptomatic BPH.
- The patients have clear indi¬cation for endoscopic surgery (according to the guidelines).
- Clinically fit patients for surgery.
- Signed an informed consent.
Key exclusion criteria (1 listed)
- Prostate cancer Previous urethral or prostate surgery Neurogenic bladder Urethral stricture Poor general condition of the patient
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 |
|---|---|---|
| Transurethral resection of the prostate- After an initial cysto-urethroscopy assessment done, Transurethral resection of the prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia. | Procedure or surgery | Transurethral resection of the prostate group (TURP). |
| transurethral enucleation of prostateAfter an initial cysto-urethroscopy assessment done, transurethral enucleation of prostate is performed using the bipolar system with normal saline irrigation, under spinal or general anesthesia. | Procedure or surgery | transurethral enucleation of prostate group (TUEP) |
Primary outcome
Time of operation
Time frame: intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)
time used for resection or enucleation and resection of the prostate
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Derived from this study: PubMed 41580733Mostafa MM, Ibrahim AF, Moeen AM, Elgammal MA, El-Azab AS, Faragallah MA. Bipolar resection versus enucleation of the prostate in management of benign prostatic hyperplasia patients with large-sized prostates: a prospective randomized controlled clinical trial. BMC Urol. 2026 Jan 24;26(1):52. doi: 10.1186/s12894-025-02004-1.
- 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.
MOHAMED F ABBAS, MD principal investigator
AUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transurethral resection of the prostate and transurethral enucleation of prostate in people with BPH, run by Assiut 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 4 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 15 Apr 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ahmed F Hassan, Master (01069569946, ahmedfarahat358@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of operation (time frame: intraoperative (from the start of resection or enucleation till the fixation of urethral catheter)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05330156, which also lists 1 linked publication.
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 15 Apr 2022.