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NCT Number: NCT06983444

Bipolar Resection vs Enucleation of Prostate

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

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Requiring Surgical Resection Benign Prostatic Hyperplasia With Lower Urinary Tract Symptoms Benign Prostatic Hyperplasia With Outflow Obstruction Benign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract Symptoms Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

50 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine South Valley University

Qina, Qena Governorate, 83523, Egypt

Location status: Recruiting

Location contact

Ahmad Abolyosr Mohammed, Doctorate

CONTACT

[email protected]

00201006947950 ext. 002

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)

Exclusion criteria

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

Treatment and study plan

TURP

Procedure

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

Other names: Transurethral resection of prostate, Bipolar TURP

TUEP

Procedure

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

Other names: Transurethral enucleation of prostate, Bipolar TUEP, Anatomical endoscopic enucleation of prostate, AEEP

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

    Time frame: at least 6 months up to one year

    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.

Secondary outcomes

  1. Operative time in minutes in each group of intervention

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

    To determine operative time in minutes in each group of intervention

  2. Compare complication rate of TURP versus TUEP

    Time frame: at least 6 months up to one year

    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

  3. Cost effectiveness of TURP versus TUEP in achieving catheter-free rates in BPH patients with urinary retention

    Time frame: at least 6 months up to one year

    To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)

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

    Time frame: at least 6 months up to one year

    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

  5. Compare patient reported symptom measures by Michigan Incontinence Symptom Index (M-ISI) questionnaire after TURP versus TUEP

    Time frame: at least 6 months up to one year

    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

  6. Compare patient reported symptom measures by IIEF-5 questionnaire after TURP versus TUEP

    Time frame: at least 6 months up to one year

    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

  7. Compare patient reported quality of life by SF-12 questionnaire after TURP versus TUEP

    Time frame: at least 6 months up to one year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

AHMED A.FATAH HAMED, Master's

CONTACT

[email protected]

00201146085302 ext. 002

Mostafa A.Razik Ahmed, Doctorate

CONTACT

[email protected]

00201004116386 ext. 002

Sponsors and collaborators

Lead sponsor

South Valley University

Other

Registry information

Official study 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

Acronym: TURP vs BiTUEP

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 21, 2025
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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