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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BPH patients have small prostates treated with Rezum | Active Comparator | Patients aged 45-75 years with prostate volumes of 50-80 ml, sexually active, and have severe LUTS treated with Rezum procedure |
|
| BPH patients have large prostates treated with Rezum | Active Comparator | Patients aged 45-75 years with prostate volumes of 80-120 ml, sexually active, and have severe LUTS treated with Rezum procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rezum therapy | Device | minimal invasive technique for treating BPH |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of complications | For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system | through four years |
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Inclusion Criteria:
Exclusion Criteria:
because the prostates in males only
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| Name | Affiliation | Role |
|---|---|---|
| Mohamed Samir Salem, MD | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Armed Forces College of Medicine (AFCM) | Cairo | Nozha | 4470351 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32408768 | Background | Bole R, Gopalakrishna A, Kuang R, Alamiri J, Yang DY, Helo S, Ziegelmann MJ, Kohler TS. Comparative Postoperative Outcomes of Rezum Prostate Ablation in Patients with Large Versus Small Glands. J Endourol. 2020 Jul;34(7):778-781. doi: 10.1089/end.2020.0177. Epub 2020 Jun 12. | |
| 30677455 | Background | McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21. |
| Label | URL |
|---|---|
| efficay of Rezum tehrapy in large prostates | View source |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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two groups
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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.
| 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 | 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. | 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 | 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. | 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. | 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 |
| 27921028 | Background | Dixon CM, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Larson TR, Mynderse LA. Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia. Res Rep Urol. 2016 Nov 21;8:207-216. doi: 10.2147/RRU.S119596. eCollection 2016. |
| D052801 |
| Male Urogenital Diseases |