Holmium Laser vs Bipolar Enucleation of a Large Volume BPH: a Randomised Controlled Study

Cairo University64 enrolled

Overview

To compare bipolar plasmakinetic enucleation versus holmium laser enucleation for management of large BPH.

To compare safety and efficacy of bipolar plasmakinetic enucleation (BPEP) versus holmium laser enucleation (HoLEP) for management of large BPH (\>80gm).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

BPH With Urinary Obstruction Male

Interventions

Holmium laser enucleation of the prostatePROCEDURE

cystoscopic transurethral enucleation of the prostate using Holmium laser (Asclepion MultiPulse HoPlus 110W and Lumenis pulse 100W and 120W)

Bipolar plasma kinetic enucleation of the prostatePROCEDURE

cystoscopic transurethral enucleation of the prostate using bipolar plasma kinetic energy (KLS Martin Maxium or Covidien Force Triad)

Eligibility

Sex: MALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients suffering from LUTS secondary to infravesical obstruction from BPH * failed medical treatment * International Prostate Symptom Score (IPSS) \> 13 * a peak urinary flow rate (Qmax) \< 15 ml/sec * a prostate size ≥ 80 gm Exclusion Criteria: * presence of a urethral stricture * neurological disorder * bladder cancer * prostate cancer * previous history of bladder neck surgery or TURP

Locations (1)

Cairo University Hospitals

Cairo, Egypt

Outcomes

Primary Outcomes

hemoglobin drop postoperatively (gm/dL)

difference in hemoglobin concentration postoperatively vs preoperatively

Time frame: Immediate postoperatively

operative time

operative time in minutes

Time frame: during surgery

Secondary Outcomes

complications (%)

intraoperative and postoperative complications including blood transfusion, capsular perforation, irritative symptoms, SUI, urethral stricture, bladder neck contracture, urinary retention.

Time frame: one year

urine flow

Qmax (ml/s),

Time frame: one year

post-voiding residual urine

postvoiding residual urine (ml)

Time frame: one year

International prostate symptom score (IPSS)

an international commonly used score ranging from 0 - 35 (the worst is 35) evaluating voiding and storage urinary symptoms using 7 questions each one is scored from 0 to 5 according to severity of symptom

Time frame: one year

Quality of life (QoL) section of International prostate symptom score (IPSS)

one question scored from 0 up to 6 (6 is worst)

Time frame: one year

Data from ClinicalTrials.gov

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