Benign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionTURP vs BiTUEPNCT06983444
Bipolar Resection vs Enucleation of Prostate
A study testing TURP and TUEP in people with Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection and Benign Prostatic Hyperplasia With Outflow Obstruction, run by South Valley University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, Benign Prostatic Hyperplasia With Outflow Obstruction, Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms
- What is being tested?
- TURP and TUEP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to Jul 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 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with lower urinary tract symptoms (LUTS) due to BPH.
- Patients with international prostate score system (IPSS) more than 8.
- Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
- Patients with Prostatic volume (60 - 100 gm).
- Patient with indication for surgical intervention.
- Patient age (50-80 years old)
Who cannot join
- Prostatic cancer.
- Bladder cancer.
- Urethral stricture.
- Neurogenic bladder.
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
Faculty of Medicine South Valley University
Qina, Qena Governorate, 83523
Ahmad Abolyosr Mohammed, Doctorate, 00201006947950 ext. 002, AhmadAbolyosr@med.svu.edu.eg
About this study
Official title: Bipolar Trans Urethral Resection of the Prostate (TURP) Versus Bipolar Enucleation of the Prostate in Treatment of Benign Prostatic Hyperplasia (BPH): A Prospective Randomized Comparative Clinical Study
The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.
Read the detailed description
Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.
Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.
Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.
Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.
Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.
A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
- Conditions
- Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, Benign Prostatic Hyperplasia With Outflow Obstruction, Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
- Being tested
- TURP, TUEP
- Keywords
- TURP, TUEP, BPH
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TURPProcedure or surgery
Also called Transurethral resection of prostate, Bipolar TURP
Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH.
TUEPProcedure or surgery
Also called Transurethral enucleation of prostate, Bipolar TUEP, Anatomical endoscopic enucleation of prostate, AEEP
Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate.
| Study group | Role | What they receive |
|---|---|---|
| Transurethral resection of prostate | Active comparator | Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care. Receives: Procedure: TURP |
| Transuretheral enucleation of prostate | Active comparator | Transurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care. Receives: Procedure: TUEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms
To determine number of patients in each group that will be Catheter and lower urinary tract symptoms free with changes in IPPS < 20 score after intervention and follow up at 1 month, 3 months and 6 months.
Measured: at least 6 months up to one year
Secondary outcomes (7)
Operative time in minutes in each group of intervention
To determine operative time in minutes in each group of intervention
Measured: 60 - 90 minutes for each group of intervention
Compare complication rate of TURP versus TUEP
To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification).
- Minimum score is class I: No intervention needed
- Maximum score is class V: Death of a patient
Measured: at least 6 months up to one year
Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention
To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)
Measured: at least 6 months up to one year
Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP
sing International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention
minimal score: 0, maximum score is 35 higher score means worse outcome
Measured: at least 6 months up to one year
Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP
Using the Michigan Incontinence Symptom Index (M-ISI) questionnaire to determine patient reported symptom measure after each intervention
- Minimum score: 1
- Maximum score: 12
- The higher the score means worse outcome
Measured: at least 6 months up to one year
Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP
Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention
minimum score: 1, maximum score: 25 higher score means better outcome
Measured: at least 6 months up to one year
Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP
sing the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention
minimum score: 0, maximum score: 100 higher score means better outcome
Measured: at least 6 months up to one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionStudies 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
- A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- South Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Abdelfattah Hamed Abdelraheem, South Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06983444
- Sponsor's protocol ID
- Endoscopic surgery prostate
- Acronym
- TURP vs BiTUEP
- Status last verified
- May 2025
- First submitted
- 29 Apr 2025
- Last updated
- 21 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.
PubMed 30816336Seitz M, Sroka R, Gratzke C, Schlenker B, Steinbrecher V, Khoder W, Tilki D, Bachmann A, Stief C, Reich O. The diode laser: a novel side-firing approach for laser vaporisation of the human prostate--immediate efficacy and 1-year follow-up. Eur Urol. 2007 Dec;52(6):1717-22. doi: 10.1016/j.eururo.2007.06.028. Epub 2007 Jun 26.
PubMed 17628326Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18.
PubMed 16126327Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23.
PubMed 21883820Arcaniolo D, Manfredi C, Veccia A, Herrmann TRW, Lima E, Mirone V, Fusco F, Fiori C, Antonelli A, Rassweiler J, Liatsikos E, Porpiglia F, De Sio M, Autorino R; EAU Section of Uro-Technology (ESUT) Research Group. Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: an ESUT systematic review and cumulative analysis. World J Urol. 2020 May;38(5):1177-1186. doi: 10.1007/s00345-019-02890-9. Epub 2019 Jul 25.
PubMed 31346761Ho HS, Yip SK, Lim KB, Fook S, Foo KT, Cheng CW. A prospective randomized study comparing monopolar and bipolar transurethral resection of prostate using transurethral resection in saline (TURIS) system. Eur Urol. 2007 Aug;52(2):517-22. doi: 10.1016/j.eururo.2007.03.038. Epub 2007 Mar 28.
PubMed 17416453
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bipolar Trans Urethral Resection of the Prostate (TURP) Versus Bipolar Enucleation of the Prostate in Treatment of Benign Prostatic Hyperplasia (BPH): A Prospective Randomized Comparative Clinical Study
- ClinicalTrials.gov ID
- NCT06983444
- Acronym / sponsor ID
- TURP vs BiTUEP / Endoscopic surgery prostate
- Conditions
- Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, Benign Prostatic Hyperplasia With Outflow Obstruction, Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
- Keywords
- TURP, TUEP, BPH
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- South Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 21 May 2025 (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.
The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.
Detailed description
Endoscopic management of benign prostatic hyperplasia (BPH), monopolar transurethral resection of the prostate (TURP) has been the gold standard for many years.
Despite its promising efficacy in treating BPH, TURP is associated with a risk of significant complications and clinical limitations, including life-threatening events such as transurethral resection (TUR) syndrome, as well as high cost due to long hospital stay, long catheterization time and difficulty in management of large sized prostate so alternative surgical approaches have been explored.
Minimally invasive approaches achieve equal efficiency to standard resection, but with a more favorable safety and less complications.
Anatomical enucleation of the prostate using Bipolar or Laser-based approaches such as holmium laser have been introduced with success and the efficacy and safety of these procedure has led to the integration into several international guidelines.
Early results of bipolar enucleation resemble those reported for holmium laser procedure, Bipolar transurethral enucleation of the prostate was at least equally effective, and showed less complications, good hemostatic control and both shorter catheterization time and hospital stay than old standard procedure.
A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
| Arm | Type | Receives |
|---|---|---|
| Transurethral resection of prostate | Active comparator | Procedure: TURPTransurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care. |
| Transuretheral enucleation of prostate | Active comparator | Procedure: TUEPTransurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with lower urinary tract symptoms (LUTS) due to BPH.
- Patients with international prostate score system (IPSS) more than 8.
- Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
- Patients with Prostatic volume (60 - 100 gm).
- Patient with indication for surgical intervention.
Key exclusion criteria (4 listed)
- Prostatic cancer.
- Bladder cancer.
- Urethral stricture.
- Neurogenic bladder.
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 |
|---|---|---|
| TURPAlso: Transurethral resection of prostate, Bipolar TURPUsing bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH. | Procedure or surgery | Transurethral resection of prostate |
| TUEPAlso: Transurethral enucleation of prostate, Bipolar TUEP, Anatomical endoscopic enucleation of prostate, AEEPUsing bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate. | Procedure or surgery | Transuretheral enucleation of prostate |
Primary outcome
Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms
Time frame: at least 6 months up to one year
To determine number of patients in each group that will be Catheter and lower urinary tract symptoms free with changes in IPPS < 20 score after intervention and follow up at 1 month, 3 months and 6 months.
7 secondary outcomes
Operative time in minutes in each group of intervention
Time frame: 60 - 90 minutes for each group of intervention
Compare complication rate of TURP versus TUEP
Time frame: at least 6 months up to one year
Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention
Time frame: at least 6 months up to one year
Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP
Time frame: at least 6 months up to one year
Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP
Time frame: at least 6 months up to one year
Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP
Time frame: at least 6 months up to one year
Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP
Time frame: at least 6 months up to one year
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 21 May 2025.
- Background: PubMed 30816336Zhang Y, Yuan P, Ma D, Gao X, Wei C, Liu Z, Li R, Wang S, Liu J, Liu X. Efficacy and safety of enucleation vs. resection of prostate for treatment of benign prostatic hyperplasia: a meta-analysis of randomized controlled trials. Prostate Cancer Prostatic Dis. 2019 Dec;22(4):493-508. doi: 10.1038/s41391-019-0135-4. Epub 2019 Feb 28.
- Background: PubMed 17628326Seitz M, Sroka R, Gratzke C, Schlenker B, Steinbrecher V, Khoder W, Tilki D, Bachmann A, Stief C, Reich O. The diode laser: a novel side-firing approach for laser vaporisation of the human prostate--immediate efficacy and 1-year follow-up. Eur Urol. 2007 Dec;52(6):1717-22. doi: 10.1016/j.eururo.2007.06.028. Epub 2007 Jun 26.
- Background: PubMed 16126327Bachmann A, Schurch L, Ruszat R, Wyler SF, Seifert HH, Muller A, Lehmann K, Sulser T. Photoselective vaporization (PVP) versus transurethral resection of the prostate (TURP): a prospective bi-centre study of perioperative morbidity and early functional outcome. Eur Urol. 2005 Dec;48(6):965-71; discussion 972. doi: 10.1016/j.eururo.2005.07.001. Epub 2005 Jul 18.
- Background: PubMed 21883820Gilling PJ, Wilson LC, King CJ, Westenberg AM, Frampton CM, Fraundorfer MR. Long-term results of a randomized trial comparing holmium laser enucleation of the prostate and transurethral resection of the prostate: results at 7 years. BJU Int. 2012 Feb;109(3):408-11. doi: 10.1111/j.1464-410X.2011.10359.x. Epub 2011 Aug 23.
- Background: PubMed 31346761Arcaniolo D, Manfredi C, Veccia A, Herrmann TRW, Lima E, Mirone V, Fusco F, Fiori C, Antonelli A, Rassweiler J, Liatsikos E, Porpiglia F, De Sio M, Autorino R; EAU Section of Uro-Technology (ESUT) Research Group. Bipolar endoscopic enucleation versus bipolar transurethral resection of the prostate: an ESUT systematic review and cumulative analysis. World J Urol. 2020 May;38(5):1177-1186. doi: 10.1007/s00345-019-02890-9. Epub 2019 Jul 25.
- Background: PubMed 17416453Ho HS, Yip SK, Lim KB, Fook S, Foo KT, Cheng CW. A prospective randomized study comparing monopolar and bipolar transurethral resection of prostate using transurethral resection in saline (TURIS) system. Eur Urol. 2007 Aug;52(2):517-22. doi: 10.1016/j.eururo.2007.03.038. Epub 2007 Mar 28.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TURP and TUEP in people with Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection and Benign Prostatic Hyperplasia With Outflow Obstruction, run by South Valley 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 6 inclusion and 4 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 21 May 2025. 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 AHMED A.FATAH HAMED, Master's (00201146085302 ext. 002, ahmeda.hamed1991@med.svu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Catheter and lower urinary tract symptoms free after Bipolar Transurethral resection of prostate (TURP) versus Bipolar Transurethral enucleation of prostate (TUEP) in patient with BPH with lower urinary tract symptoms (time frame: at least 6 months up to one year). 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 NCT06983444, which also lists 6 linked publications.
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 21 May 2025.