Bipolar Resection vs Enucleation of Prostate

NCT06983444 | Recruiting

• 1 other identifier: Endoscopic surgery prostate
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the 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

Outcome Measures

Primary Outcomes (1)

• 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.

  at least 6 months up to one year

Secondary Outcomes (7)

• Operative time in minutes in each group of intervention

  60 - 90 minutes for each group of intervention

• Compare complication rate of TURP versus TUEP

  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

  at least 6 months up to one year

• Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP

  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

  at least 6 months up to one year

Study Arms (2)

Transurethral resection of prostate

ACTIVE COMPARATOR

Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.

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.

Procedure: TUEP

Interventions

TURP PROCEDURE

Using bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH.

Also known as: Transurethral resection of prostate, Bipolar TURP

Transurethral resection of prostate

TUEP PROCEDURE

Using bipolar enucleation loop diathermy via cystoscopy, to anatomically enucleate prostate.

Also known as: Transurethral enucleation of prostate, Bipolar TUEP, Anatomical endoscopic enucleation of prostate, AEEP

Transuretheral enucleation of prostate

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: male patient with BPH
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Prostatic cancer.
• Bladder cancer.
• Urethral stricture.
• Neurogenic bladder.

Sponsors & Collaborators

• South Valley University: lead

Study Sites (1)

Faculty of Medicine South Valley University

Qina, Qena Governorate, 83523, Egypt

RECRUITING

Related Publications (6)

• 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.

  PMID: 30816336 BACKGROUND

• Seitz 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.

  PMID: 17628326 BACKGROUND

• Bachmann 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.

  PMID: 16126327 BACKGROUND

• Gilling 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.

  PMID: 21883820 BACKGROUND

• Arcaniolo 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.

  PMID: 31346761 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

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Central Study Contacts

AHMED A.FATAH HAMED, Master's

CONTACT

00201146085302; ahmeda.hamed1991@med.svu.edu.eg

Mostafa A.Razik Ahmed, Doctorate

CONTACT

00201004116386; mostafa_uro@med.svu.edu.eg

Study Design

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

Model Details: A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.

Study Record Dates

• First Submitted: April 29, 2025
• First Posted: May 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)