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

Not Applicable
Completed
Conditions
BPH With Urinary Obstruction
Male
Registration Number
NCT04935151
Lead Sponsor
Cairo University
Brief Summary

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

Detailed Description

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

Recruitment & Eligibility

Status
COMPLETED
Sex
Male
Target Recruitment
112
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
hemoglobin drop postoperatively (gm/dL)within two hours after surgery

change in hemoglobin concentration postoperatively vs preoperatively

Secondary Outcome Measures
NameTimeMethod
operative duration in minutesTime lapsed during surgery

operative duration

Hospital stayFrom time of randomisation up to last day of admission in hospital (in days) up to 30 days

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

blood transfusionduring surgery and hospitalisation up to 10 days

rate of blood transfusion

Trial Locations

Locations (2)

Cairo University Hospitals

🇪🇬

Cairo, Egypt

Theodor Bilharz research institute

🇪🇬

Giza, Egypt

Cairo University Hospitals
🇪🇬Cairo, Egypt

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