Male Clinical Trial
Official title:
Holmium Laser Enucleation Versus Bipolar Resection in the Management of a Large Volume (> 80 gm) Symptomatic BPH: a Randomised Controlled Trial
Verified date | June 2021 |
Source | Cairo University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
To compare bipolar resection versus holmium laser enucleation for management of symptomatic large BPH (> 80 gm)
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University Hospitals | Cairo | |
Egypt | Theodor Bilharz research institute | Giza |
Lead Sponsor | Collaborator |
---|---|
Cairo University | Theodor Bilharz Research Institute |
Egypt,
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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