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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04935151
Other study ID # REC-TBRI-PT563
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 4, 2016
Est. completion date March 10, 2021

Study information

Verified date June 2021
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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


Recruitment information / eligibility

Status Completed
Enrollment 112
Est. completion date March 10, 2021
Est. primary completion date March 6, 2018
Accepts healthy volunteers No
Gender Male
Age group 45 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Procedure:
holmium laser enucleation of the prostate
cystoscopic transurethral enucleation of the prostate using Holmium laser
Bipolar resection of the prostate
cystoscopic transurethral resection of the prostate using bipolar energy

Locations

Country Name City State
Egypt Cairo University Hospitals Cairo
Egypt Theodor Bilharz research institute Giza

Sponsors (2)

Lead Sponsor Collaborator
Cairo University Theodor Bilharz Research Institute

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Other complications (percent) All complications Three years
Other 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 Three years
Other Quality of life (QoL) section of International prostate symptom score (IPSS) one question scored from 0 up to 6 (6 is worst) Three years
Other flowmetry rate of flow (ml urine) per second Three years
Primary hemoglobin drop postoperatively (gm/dL) change in hemoglobin concentration postoperatively vs preoperatively within two hours after surgery
Secondary operative duration in minutes operative duration Time lapsed during surgery
Secondary Hospital stay Hospitalisation starting from day of surgery till the day of discharge from Hospital in days From time of randomisation up to last day of admission in hospital (in days) up to 30 days
Secondary blood transfusion rate of blood transfusion during surgery and hospitalisation up to 10 days
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