B-TURP vs BipolEP in Management of BPH Patients With Medium-sized Prostates

NCT06939062 | Completed

• 1 other identifier: B-TURP vs BipolEP
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia (BPH); Bipolar enucleation of the prostate (BipolEP); Bipolar Transurethral reaction of the prostate (B-TURP)

Outcome Measures

Primary Outcomes (1)

• 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

  At 6 months after the procedure (BipolEP or B-TURP)

Secondary Outcomes (1)

• Complications

  At 6 months after the procedure (BipolEP or B-TURP)

Study Arms (2)

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)

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)

Procedure: Bipolar transurethral resection of the prostate (B-TURP)

Interventions

Bipolar enucleation of the prostate (BipolEP) PROCEDURE

Endoscopic transurethral enucleation of the prostate using bipolar energy

Bipolar enucleation of the prostate (BipolEP) patients

Bipolar transurethral resection of the prostate (B-TURP) PROCEDURE

Endoscopic transurethral resection of the prostate using bipolar energy

Bipolar transurethral resection of the prostate (B-TURP) patients

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Urology Hospital

Asyut, Egypt

Location

Related Publications (8)

• 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.

  PMID: 24502959 BACKGROUND

• Bhansali 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.

  PMID: 19178175 BACKGROUND

• Ho 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.

  PMID: 17416453 BACKGROUND

• Singh 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.

  PMID: 15865523 BACKGROUND

• Ahyai 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.

  PMID: 20825758 BACKGROUND

• Gratzke 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.

  PMID: 25613154 BACKGROUND

• Kok 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.

  PMID: 19091352 BACKGROUND

• GBD 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.

  PMID: 36273485 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Urology

Study Record Dates

• First Submitted: April 15, 2025
• First Posted: April 22, 2025
• Study Start: July 1, 2022
• Primary Completion: June 1, 2025
• Study Completion: July 1, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)