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
The aim of this study is to evaluate efficacy and safety of transurethral resection of the prostate and bipolar enucleation of the prostate.
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.
Exclusion Criteria:
Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.
Procedure: TURP
Transurethral enucleation of prostate (TUEP) will be performed under spinal or general anesthesia as per usual care.
Procedure: TUEP
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
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
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
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
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
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
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
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
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
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
Plan to share: No
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