The investigators aimed to compare the efficacy and safety of Rezūm therapy for the management of benign prostatic hyperplasia (BPH) in small and large prostates.
For decades, Transurethral resection of the prostate (TURP) was the gold standard surgical intervention for small and moderate prostates, however it has high morbidity and prolonged hospital stay Rezūm is a radiofrequency made water vapour thermal treatment. It has recently been added to the international guidelines as a choice for medical treatment resistant lower urinary tract symptoms (LUTS). The AUA and Canadian Urological Association (CUA) guidelines now add water vapour therapy as a treatment option for BPH patients with small prostate size \<80 gm and for those wishing to maintain antegrade ejaculation. While investigators still offer no clear recommendation to Rezūm use for those with large prostates.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
178
minimal invasive technique for treating BPH
The Armed Forces College of Medicine (AFCM)
Cairo, Nozha, Egypt
The Maximum Urinary flow rate (Qmax)
Measurement of The Maximum Urinary flow rate (Qmax) in both groups After 3, 12, 24, 36 and 48 months of operation, the procedure is performed. Qmax is measured by (ml/sec) Normal values are described as a Qmax above 15 ml/sec and below 10 ml/sec is considered abnormal
Time frame: for each case in both groups the investigator assess Qmax at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years]
The Quality of Life (QoL)
Measurement of The Quality of Life (QoL) in both groups After 3, 12, 24, 36 and 48 months of operation, the questioner is performed. Minimum :0 means delighted / Maximum : 5 means unhappy
Time frame: for each case in both groups the investigator assess QoLat 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years]
The Prostatic specific antigen (PSA)
Concentration of The Prostatic specific antigen (PSA) in both groups after 3, 12, 24, 36 and 48 months of operation, the procedure is performed. PSA is measured by ng/ml PSA levels of 4.0 ng/ mL and lower were considered
Time frame: for each case in both groups the investigator measures PSA at 3, 12, and 24, 36 and 48 months after procedures through study completion, an average of 4 years
The International Prostate Symptom score (IPSS)
Measurement of The International Prostate Symptom score (IPSS) in both groups After 3, 12, 24, 36 and 48 months of operation, the questioner is performed. Minimum :0 / Maximum : 35 Total score: 0-7 Mildly symptomatic; 8-19 moderately symptomatic; 20-35 severely symptomatic
Time frame: for each case in both groups the investigator assess IPSS at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years
The International Index of Erectile Function (IIEF)
Measurement of The International Index of Erectile Function (IIEF) in both groups After 3, 12, 24, 36 and 48 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items.
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Time frame: for each case in both groups the investigator assess IIEF at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years
The Prostate size
the prostate size was measured by grams by Trans-rectal ultra sound
Time frame: for each case in both groups the investigator assess prostate size at 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years
The operative time
the operative time was measured by minutes in both groups.
Time frame: for each case in both groups the investigator assess the time of operation from induction of anaesthesia till the end of the operation through study completion, an average of 4 years
Incidence of The catheter duration post operative
The catheter duration was measured by days in both groups
Time frame: for each case in both groups the investigator assess the catheter duration from the end of the operation till removal through study completion, an average of 4 years
Post operative hospital stay time
the Post operative hospital stay time was measured by hours in both groups.
Time frame: for each case in both groups the investigator assess the hospital time from the day of admission of the patient in hospital to do intervention till discharge from hospital through study completion, an average of 4 years
Post operative residual urine (PVR)
PVR was measured by ml by pelvi abdominal ultra sound in both groups. Normal ranges are below 150 ml of urine.
Time frame: for each case in both groups the investigator assess prostate size at 3, 12, 24, 36 and 48 months after procedures through study completion, an average of 4 years
Incidence of complications
For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system
Time frame: through four years