Benign Prostatic HyperplasiaNCT06939062
B-TURP vs BipolEP in Management of BPH Patients With Medium-sized Prostates
A study testing Bipolar enucleation of the prostate (BipolEP) and Bipolar transurethral resection of the prostate (B-TURP) in people with Benign Prostatic Hyperplasia, run by Assiut University at 1 site in Egypt.
Trial summary
This is a comparative study of the efficacy and safety of endoscopic bipolar transurethral resection and enucleation of the prostate in management of benign prostatic hyperplasia patients with medium-sized prostates Read more about this study
- Who is it for?
- Ages 45 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Bipolar enucleation of the prostate (BipolEP) and Bipolar transurethral resection of the prostate (B-TURP)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 63 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Jul 2025
- 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 45 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male patients aged 45-80 years with symptomatic BPH (IPSS ≥8).
- Prostate volume between 40-80 cc as determined by transrectal ultrasound (TRUS).
- Failure of medical management.
- Written informed consent.
Who cannot join
- Prostate cancer (suspected on PSA/DRE or confirmed by biopsy).
- Previous prostate/urethral surgery.
- Neurogenic bladder or urethral strictures.
- Significant coagulopathy.
- Uncontrolled urinary tract infection.
- Patient on anticoagulant medication.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of Bipolar Resection Versus Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Medium-sized Prostates: A Prospective Randomized Controlled Clinical Trial
This is a comparative study of the efficacy and safety of endoscopic bipolar transurethral resection and enucleation of the prostate in management of benign prostatic hyperplasia patients with medium-sized prostates
Read the detailed description
Benign prostatic hyperplasia (BPH) is a highly prevalent condition among aging males, with incidence rates escalating progressively with age. Epidemiological data indicate that approximately 8% of men in their fourth decade are affected, a proportion that rises to 50% by the sixth decade and exceeds 80% in individuals reaching their ninth decade. BPH may induce bladder outlet obstruction (BOO), leading to lower urinary tract symptoms (LUTS). LUTS are one of the most frequent urological complaints in aging males. LUTS are typically categorized into obstructive and storage subtypes, with clinical BPH representing the predominant underlying etiology.
Approximately 20% of men with BPH will eventually require surgical intervention. Transurethral resection of the prostate (TURP) remains the gold-standard surgical treatment, offering both immediate relief of intravesical obstruction and durable improvement in voiding parameters and symptoms. However, the procedure carries significant risks, including perioperative bleeding and transurethral resection syndrome (TUR syndrome), with complication rates increasing proportionally to prostate size.
The recent technological advancements in urological equipment have led to increased adoption of bipolar transurethral resection of the prostate (B-TURP) for BPH management. This technique employs a plasma kinetic system that provides superior coagulation capabilities. A significant advantage of B-TURP is its use of normal saline irrigation, which substantially reduces the risk of TUR syndrome compared to conventional methods. Clinical studies have demonstrated B-TURP's efficacy in relieving bladder outlet obstruction secondary to BPH, with outcomes comparable to traditional approaches.
Despite advancements in TURP technology, incidence of complications such as postoperative recurrence remained unchanged, necessitating surgical innovation. In this context, bipolar enucleation of the prostate (BipoLEP) has emerged as an alternative technique designed to address these challenges. Our study was designed to conduct a comparative analysis of BipoLEP versus bipolar B-TURP in the treatment of medium-sized BPH patients.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Bipolar enucleation of the prostate (BipolEP), Bipolar transurethral resection of the prostate (B-TURP)
- Keywords
- Benign Prostatic Hyperplasia (BPH), Bipolar enucleation of the prostate (BipolEP), Bipolar Transurethral reaction of the prostate (B-TURP)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar enucleation of the prostate (BipolEP)Procedure or surgery
Endoscopic transurethral enucleation of the prostate using bipolar energy
Bipolar transurethral resection of the prostate (B-TURP)Procedure or surgery
Endoscopic transurethral resection of the prostate using bipolar energy
| Study group | Role | What they receive |
|---|---|---|
| Bipolar enucleation of the prostate (BipolEP) patients | Active comparator | Benign prostatic hyperplasia patients with medium -sized prostates who will undergo Bipolar enucleation of the prostate (BipolEP) Receives: Procedure: Bipolar enucleation of the prostate (BipolEP) |
| Bipolar transurethral resection of the prostate (B-TURP) patients | Active comparator | Benign prostatic hyperplasia patients with medium -sized prostates who will undergo Bipolar transurethral resection of the prostate (B-TURP) Receives: Procedure: Bipolar transurethral resection of the prostate (B-TURP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in international prostate symptom score (IPSS)
Treatment efficacy will be evaluated by comparing the change in international prostate symptom score (IPSS) between the two groups
Measured: At 6 months after the procedure (BipolEP or B-TURP)
Secondary outcomes (1)
Complications
Treatment safety will be evaluated by collecting and analyzing any reported complication within the first 6 postoperative months. Complications will be reported using the modified Clavien-Dindo classification system.
Measured: At 6 months after the procedure (BipolEP or B-TURP)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2025
- Study start1 Jul 2022
- Primary completion1 Jun 2025
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Mohamed Atef Abdelaziz Mostafa, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06939062
- Sponsor's protocol ID
- B-TURP vs BipolEP
- Status last verified
- Jul 2025
- First submitted
- 15 Apr 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be made available to protect privacy of patients
Publications
Chen S, Zhu L, Cai J, Zheng Z, Ge R, Wu M, Deng Z, Zhou H, Yang S, Wu W, Liao L, Tan J. Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: a randomized noninferiority controlled trial with long-term results at 6 years. Eur Urol. 2014 Aug;66(2):284-91. doi: 10.1016/j.eururo.2014.01.010. Epub 2014 Jan 24.
PubMed 24502959Bhansali M, Patankar S, Dobhada S, Khaladkar S. Management of large (>60 g) prostate gland: PlasmaKinetic Superpulse (bipolar) versus conventional (monopolar) transurethral resection of the prostate. J Endourol. 2009 Jan;23(1):141-5. doi: 10.1089/end.2007.0005.
PubMed 19178175Ho 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 17416453Singh H, Desai MR, Shrivastav P, Vani K. Bipolar versus monopolar transurethral resection of prostate: randomized controlled study. J Endourol. 2005 Apr;19(3):333-8. doi: 10.1089/end.2005.19.333.
PubMed 15865523Ahyai SA, Gilling P, Kaplan SA, Kuntz RM, Madersbacher S, Montorsi F, Speakman MJ, Stief CG. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010 Sep;58(3):384-97. doi: 10.1016/j.eururo.2010.06.005. Epub 2010 Jun 11.
PubMed 20825758Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PubMed 25613154Kok ET, Schouten BW, Bohnen AM, Groeneveld FP, Thomas S, Bosch JL. Risk factors for lower urinary tract symptoms suggestive of benign prostatic hyperplasia in a community based population of healthy aging men: the Krimpen Study. J Urol. 2009 Feb;181(2):710-6. doi: 10.1016/j.juro.2008.10.025. Epub 2008 Dec 16.
PubMed 19091352GBD 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2022 Nov;3(11):e754-e776. doi: 10.1016/S2666-7568(22)00213-6. Epub 2022 Oct 20.
PubMed 36273485
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Bipolar Resection Versus Enucleation of the Prostate in Management of Benign Prostatic Hyperplasia Patients With Medium-sized Prostates: A Prospective Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06939062
- Acronym / sponsor ID
- B-TURP vs BipolEP
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Benign Prostatic Hyperplasia (BPH), Bipolar enucleation of the prostate (BipolEP), Bipolar Transurethral reaction of the prostate (B-TURP)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 22 Apr 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.
This is a comparative study of the efficacy and safety of endoscopic bipolar transurethral resection and enucleation of the prostate in management of benign prostatic hyperplasia patients with medium-sized prostates
Detailed description
Benign prostatic hyperplasia (BPH) is a highly prevalent condition among aging males, with incidence rates escalating progressively with age. Epidemiological data indicate that approximately 8% of men in their fourth decade are affected, a proportion that rises to 50% by the sixth decade and exceeds 80% in individuals reaching their ninth decade. BPH may induce bladder outlet obstruction (BOO), leading to lower urinary tract symptoms (LUTS). LUTS are one of the most frequent urological complaints in aging males. LUTS are typically categorized into obstructive and storage subtypes, with clinical BPH representing the predominant underlying etiology.
Approximately 20% of men with BPH will eventually require surgical intervention. Transurethral resection of the prostate (TURP) remains the gold-standard surgical treatment, offering both immediate relief of intravesical obstruction and durable improvement in voiding parameters and symptoms. However, the procedure carries significant risks, including perioperative bleeding and transurethral resection syndrome (TUR syndrome), with complication rates increasing proportionally to prostate size.
The recent technological advancements in urological equipment have led to increased adoption of bipolar transurethral resection of the prostate (B-TURP) for BPH management. This technique employs a plasma kinetic system that provides superior coagulation capabilities. A significant advantage of B-TURP is its use of normal saline irrigation, which substantially reduces the risk of TUR syndrome compared to conventional methods. Clinical studies have demonstrated B-TURP's efficacy in relieving bladder outlet obstruction secondary to BPH, with outcomes comparable to traditional approaches.
Despite advancements in TURP technology, incidence of complications such as postoperative recurrence remained unchanged, necessitating surgical innovation. In this context, bipolar enucleation of the prostate (BipoLEP) has emerged as an alternative technique designed to address these challenges. Our study was designed to conduct a comparative analysis of BipoLEP versus bipolar B-TURP in the treatment of medium-sized BPH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar enucleation of the prostate (BipolEP) patients | Active comparator | Procedure: Bipolar enucleation of the prostate (BipolEP)Benign prostatic hyperplasia patients with medium -sized prostates who will undergo Bipolar enucleation of the prostate (BipolEP) |
| Bipolar transurethral resection of the prostate (B-TURP) patients | Active comparator | Procedure: Bipolar transurethral resection of the prostate (B-TURP)Benign prostatic hyperplasia patients with medium -sized prostates who will undergo Bipolar transurethral resection of the prostate (B-TURP) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male patients aged 45-80 years with symptomatic BPH (IPSS ≥8).
- Prostate volume between 40-80 cc as determined by transrectal ultrasound (TRUS).
- Failure of medical management.
- Written informed consent.
Key exclusion criteria (6 listed)
- Prostate cancer (suspected on PSA/DRE or confirmed by biopsy).
- Previous prostate/urethral surgery.
- Neurogenic bladder or urethral strictures.
- Significant coagulopathy.
- Uncontrolled urinary tract infection.
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 |
|---|---|---|
| Bipolar enucleation of the prostate (BipolEP)Endoscopic transurethral enucleation of the prostate using bipolar energy | Procedure or surgery | Bipolar enucleation of the prostate (BipolEP) patients |
| Bipolar transurethral resection of the prostate (B-TURP)Endoscopic transurethral resection of the prostate using bipolar energy | Procedure or surgery | Bipolar transurethral resection of the prostate (B-TURP) patients |
Primary outcome
Change in international prostate symptom score (IPSS)
Time frame: At 6 months after the procedure (BipolEP or B-TURP)
Treatment efficacy will be evaluated by comparing the change in international prostate symptom score (IPSS) between the two groups
1 secondary outcome
Complications
Time frame: At 6 months after the procedure (BipolEP or B-TURP)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Results publication: PubMed 24502959Chen S, Zhu L, Cai J, Zheng Z, Ge R, Wu M, Deng Z, Zhou H, Yang S, Wu W, Liao L, Tan J. Plasmakinetic enucleation of the prostate compared with open prostatectomy for prostates larger than 100 grams: a randomized noninferiority controlled trial with long-term results at 6 years. Eur Urol. 2014 Aug;66(2):284-91. doi: 10.1016/j.eururo.2014.01.010. Epub 2014 Jan 24.
- Results publication: PubMed 19178175Bhansali M, Patankar S, Dobhada S, Khaladkar S. Management of large (>60 g) prostate gland: PlasmaKinetic Superpulse (bipolar) versus conventional (monopolar) transurethral resection of the prostate. J Endourol. 2009 Jan;23(1):141-5. doi: 10.1089/end.2007.0005.
- Results publication: 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.
- Results publication: PubMed 15865523Singh H, Desai MR, Shrivastav P, Vani K. Bipolar versus monopolar transurethral resection of prostate: randomized controlled study. J Endourol. 2005 Apr;19(3):333-8. doi: 10.1089/end.2005.19.333.
- Results publication: PubMed 20825758Ahyai SA, Gilling P, Kaplan SA, Kuntz RM, Madersbacher S, Montorsi F, Speakman MJ, Stief CG. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010 Sep;58(3):384-97. doi: 10.1016/j.eururo.2010.06.005. Epub 2010 Jun 11.
- Results publication: PubMed 25613154Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
- Results publication: PubMed 19091352Kok ET, Schouten BW, Bohnen AM, Groeneveld FP, Thomas S, Bosch JL. Risk factors for lower urinary tract symptoms suggestive of benign prostatic hyperplasia in a community based population of healthy aging men: the Krimpen Study. J Urol. 2009 Feb;181(2):710-6. doi: 10.1016/j.juro.2008.10.025. Epub 2008 Dec 16.
- Results publication: PubMed 36273485GBD 2019 Benign Prostatic Hyperplasia Collaborators. The global, regional, and national burden of benign prostatic hyperplasia in 204 countries and territories from 2000 to 2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet Healthy Longev. 2022 Nov;3(11):e754-e776. doi: 10.1016/S2666-7568(22)00213-6. Epub 2022 Oct 20.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be made available to protect privacy of patients
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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 Bipolar enucleation of the prostate (BipolEP) and Bipolar transurethral resection of the prostate (B-TURP) in people with Benign Prostatic Hyperplasia, 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 6 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 24 Jul 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in international prostate symptom score (IPSS) (time frame: At 6 months after the procedure (BipolEP or B-TURP)). 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 NCT06939062, which also lists 8 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 24 Jul 2025.