Clinical trial NCT06983444: Bipolar Resection vs Enucleation of Prostate
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
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
Lead sponsor: South Valley University
Sponsor class: OTHER
First posted: 2025-05-21
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A comparison between TURP and Bipolar enucleation of prostate allows us to investigate the true benefits and safety of each modality.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: Inclusion Criteria:

1. Patients with lower urinary tract symptoms (LUTS) due to BPH.
2. Patients with international prostate score system (IPSS) more than 8.
3. Patients with maximal urinary flow rate (Qmax) less than 10ml/second.
4. Patients with Prostatic volume (60 - 100 gm).
5. Patient with indication for surgical intervention.
6. Patient age (50-80 years old)

Exclusion Criteria:

1. Prostatic cancer.
2. Bladder cancer.
3. Urethral stricture.
4. Neurogenic bladder.

Primary outcomes:
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
timeFrame: at least 6 months up to one year
Secondary outcomes:
measure: Operative time in minutes in each group of intervention
timeFrame: 60 - 90 minutes for each group of intervention
measure: Compare complication rate of TURP versus TUEP
timeFrame: at least 6 months up to one year
measure: Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention
timeFrame: at least 6 months up to one year
measure: Compare patient reported symptom measures by IPSS questionnaire after TURP versus TUEP
timeFrame: at least 6 months up to one year
measure: Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP
timeFrame: at least 6 months up to one year
measure: Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP
timeFrame: at least 6 months up to one year
measure: Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP
timeFrame: at least 6 months up to one year
Other outcomes:
Locations:
city: Qinā
country: Egypt
facility: Faculty of Medicine South Valley University
state: Qena
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.