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RecruitingNCT06983444TURP vs BiTUEPUpdated May 21, 2025

Bipolar Resection vs Enucleation of Prostate

An interventional study of TURP and TUEP in Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection, Benign Prostatic Hyperplasia With Outflow Obstruction and Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms, sponsored by South Valley University. Recruiting at 1 site in Egypt. Open to male participants aged 50 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-05-21.

Sponsored by South Valley University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
50 Years to 80 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • 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
03

Who can participate

Ages eligible
50 Years to 80 Years
Sexes eligible
Male
Accepts healthy volunteers
No

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

Exclusion Criteria:

  1. Prostatic cancer.
  2. Bladder cancer.
  3. Urethral stricture.
  4. Neurogenic bladder.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Transurethral resection of prostate

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

    Procedure: TURP

  • Active comparator
    Transuretheral enucleation of prostate

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

    Procedure: TUEP

Interventions

  • ProcedureTURP

    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

  • ProcedureTUEP

    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

05

What researchers measure

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.

    Time frame: at least 6 months up to one year

Secondary outcomes

  1. Operative time in minutes in each group of intervention

    To determine operative time in minutes in each group of intervention

    Time frame: 60 - 90 minutes for each group of intervention

  2. 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

    Time frame: at least 6 months up to one year

  3. 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)

    Time frame: at least 6 months up to one year

  4. 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

    Time frame: at least 6 months up to one year

  5. 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

    Time frame: at least 6 months up to one year

  6. 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

    Time frame: at least 6 months up to one year

  7. 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

    Time frame: at least 6 months up to one year

06

Study locations

1 of 1 sites recruiting
  • Faculty of Medicine South Valley University
    Qinā, Qena 83523, Egypt
    Recruiting
07

References and documents

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 30816336 ↗
  • 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. PubMed 17628326 ↗
  • 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. PubMed 16126327 ↗
  • 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. PubMed 21883820 ↗
  • 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. PubMed 31346761 ↗
  • 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. PubMed 17416453 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT06983444
Lead sponsor
South Valley University
Responsible party
Ahmed Abdelfattah Hamed Abdelraheem (Assistant Lecturer, South Valley University) — Principal investigator
First posted
May 21, 2025
Start date
Jun 1, 2025 (estimated)
Primary completion
Jun 30, 2026 (estimated)
Completion
Jul 2026 (estimated)
Last update
May 21, 2025

Study contacts

AHMED A.FATAH HAMED, Master's
Contact
ahmeda.hamed1991@med.svu.edu.eg
00201146085302 ext. 002
Mostafa A.Razik Ahmed, Doctorate
Contact
mostafa_uro@med.svu.edu.eg
00201004116386 ext. 002

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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