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Bipolar Resection vs Enucleation of Prostate

ConditionsBenign Prostatic Hyperplasia (BPH) Requiring Surgical ResectionBenign Prostatic Hyperplasia With Outflow ObstructionBenign Prostatic Hyperplasia With Symptomatic Lower Urinary Tract SymptomsBenign Prostatic Hyperplasia With Lower Urinary Tract Symptoms
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50-80
SponsorSouth Valley University

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Prostatic cancer.

Bladder cancer.

Urethral stricture.

Neurogenic bladder.

Trial design

Design model

Parallel

Treatments tested in this trial

  • TURP

    Procedure/Surgery

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

  • TUEP

    Procedure/Surgery

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Transurethral resection of prostateActive comparator 1 intervention
Group B: Transuretheral enucleation of prostateActive comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

South Valley University

Lead sponsor

Source ClinicalTrials.gov
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