Prostate Hyperplasia
Conditions
Keywords
Rezum, LUTS
Brief summary
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.
Detailed description
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.
Interventions
DEVICERezum therapy
minimal invasive technique for treating BPH
Sponsors
khaled Abdelsattar Gad Ibrahim
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
two groups
Eligibility
Sex/Gender
MALE
Age
45 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. prostate size 45-75 gm 2. sexually active 3. mod - sever LUTS 4. Q max \< 15 5. IPSS \> 15 6. failed medical treatment with alpha blockers
Exclusion criteria
1. neurogenic bladder 2. urethral stricture 3. UB stones 4. cancer prostate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post operative residual urine (PVR) | 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 | PVR was measured by ml by pelvi abdominal ultra sound in both groups. Normal ranges are below 150 ml of urine. |
| The Maximum Urinary flow rate (Qmax) | 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] | 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 |
| The Quality of Life (QoL) | 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] | 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 |
| The Prostatic specific antigen (PSA) | 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 | 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 |
| The International Prostate Symptom score (IPSS) | 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 | 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 |
| The International Index of Erectile Function (IIEF) | 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 | 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. |
| The Prostate size | 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 prostate size was measured by grams by Trans-rectal ultra sound |
| The operative time | 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 | the operative time was measured by minutes in both groups. |
| Incidence of The catheter duration post operative | 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 | The catheter duration was measured by days in both groups |
| Post operative hospital stay time | 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 | the Post operative hospital stay time was measured by hours in both groups. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of complications | through four years | For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system |
Countries
Egypt
Outcome results
None listed