HoLEP vs BPRP in the Management of a Large Volume (> 80 gm) Symptomatic BPH

Cairo University112 enrolled

Overview

To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (\> 80 gm)

To compare safety and efficacy of bipolar resection (BPRP) versus holmium laser enucleation (HoLEP) for management of symptomatic large BPH (\> 80 gm)

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

112

Conditions

BPH With Urinary Obstruction Male

Interventions

holmium laser enucleation of the prostatePROCEDURE

cystoscopic transurethral enucleation of the prostate using Holmium laser

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 with 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 (2)

Cairo University Hospitals

Cairo, Egypt

Theodor Bilharz research institute

Giza, Egypt

Outcomes

Primary Outcomes

hemoglobin drop postoperatively (gm/dL)

change in hemoglobin concentration postoperatively vs preoperatively

Time frame: within two hours after surgery

Secondary Outcomes

operative duration in minutes

operative duration

Time frame: Time lapsed during surgery

Hospital stay

Hospitalisation starting from day of surgery till the day of discharge from Hospital in days

Time frame: From time of randomisation up to last day of admission in hospital (in days) up to 30 days

blood transfusion

rate of blood transfusion

Time frame: during surgery and hospitalisation up to 10 days

Data from ClinicalTrials.gov

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