HoLEP vs BPRP of a Large Volume BPH: a Randomised Controlled Trial

Cairo University145 enrolled

Overview

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

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of large BPH (\> 75 gm).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

145

Conditions

BPH With Urinary Obstruction Male

Interventions

holmium laser enucleation of the prostatePROCEDURE

cystoscopic transurethral enucleation of the prostate using Holmium laser (Versa pulse 100W; Lumenis; Germany)

Bipolar resection of the prostatePROCEDURE

cystoscopic transurethral resection of the prostate using bipolar energy

Eligibility

Sex: MALEMin age: 45 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 ≥ 75 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 duration in minutes

operative duration

Time frame: during surgery

Hospital stay in days

Hospital stay

Time frame: immediately after 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: Two years

urine flow

Qmax (ml/s),

Time frame: Two years

post-voiding residual urine

postvoiding residual urine (ml)

Time frame: Two years

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: Two years

Quality of life (QoL)

section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst)

Time frame: Two years

Data from ClinicalTrials.gov

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