The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia

Study Overview
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Brief Summary
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We aimed to compare the efficacy and safety of Rezūm therapy and bipolar transurethral resection of prostate (B-TURP) for the management of benign prostatic hyperplasia (BPH) of 50-120gm size.

Detailed Description
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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. In contrast to monopolar TURP (M-TURP), where prolonged resection carries the risk of transurethral resection (TUR) syndrome, bipolar transurethral resection of prostate (B-TURP), especially in large prostates was a promising procedure for urologists, but unfortunately, the morbidity rate of B-TURP remains high [4]. Therefore, newer minimally invasive procedures have been introduced to provide alternative surgical options to TURP. 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 they still offer no clear recommendation to Rezūm use for those with large prostates. Early studies on this topic have found out promising results.

Official Title
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Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.

Conditions
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Prostatic Hyperplasia

Intervention / Treatment
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* Procedure: Rezum procedure
* Procedure: B-TURP procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients aged 50-80 years prostate volumes of 50-120 ml sexually active severe LUTS [Q max] of <10 ml/s [IPSS] of >20) failed medical treatment with alpha blockers Exclusion Criteria: prostate cancer Neurogenic bladder urethral stricture urinary bladder stone previous prostatic surgery.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: BPH patients treated with Rezum procedure<br>Patients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure | Procedure: Rezum procedure<br>* In Rezūm procedure, the Rezūm System (NxThera Inc., Maple Grove, MN, USA) consists of a radiofrequency (RF) power supply generator and single-use transurethral delivery device. Starting 1 cm distal to the bladder neck, injection was done at 3 and 9 o'clock sites. The needle was inserted for 9 s duration, retracted, and then delivered to another treatment site in 1 cm distance distal to the previous one.<br>|
| Active Comparator: BPH patients treated with B-TURP procedure<br>Patients aged 50-80 years with prostate volumes of 50-120 ml, sexually active, and have severe LUTS treated with Rezum procedure | Procedure: B-TURP procedure<br>* In B-TURP, Olympus SurgMaster™ UES-40 bipolar generator (Olympus Europe, Hamburg, Germany) was used. Current's settings used were cut/coag 200/120. Using continuous flow 26Fr resectoscope first resection of the median lobe from the level of the bladder neck to the apex of the prostate was done followed by resection of the lateral lobes. Using Ellic evacuator, Prostatic chips were extracted from the field. A 22 fr three-way silicon Foley catheter was placed with traction applied and the balloon inflated by normal saline of 30-80 cc according to the size of the prostate.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of The International Prostate Symptom score (IPSS) in both groups | After 6, 12, and 24 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 6, 12, and 24 months after procedures through study completion, an average of 2 years | 
| Measurement of The Quality of Life (QoL) in both groups | After 6, 12, and 24 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 6, 12, and 24 months after procedures through study completion, an average of 2 years | 
| Measurement of The Maximum Urinary flow rate (Qmax) in both groups | After 6, 12, and 24 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 6, 12, and 24 months after procedures through study completion, an average of 2 years | 
| Concentration of The Prostatic specific antigen (PSA) in both groups | After 6, 12, and 24 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 6, 12, and 24 months after procedures through study completion, an average of 2 years | 
| Measurement of The International Index of Erectile Function (IIEF) in both groups | After 6, 12, and 24 months of operation, the questioner is performed. The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction | for each case in both groups the investigator assess IIEF at 6, 12, and 24 months after procedures through study completion, an average of 2 years | 
| Measurement of 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 24 months after procedures through study completion, an average of 2 years | 
| The operative time of both groups | 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 anaesthesiatill the end of the operation through study completion, an average of 2 years | 
| Post operative hospital stay time in both groups | 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 2 years | 
| Incidence of The catheter duration post operative in both groups | 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 2 years | 
| Measurement of 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 6, 12 and 24 months after procedures through study completion, an average of 2 years | 

Secondary Outcome Measures

| Outcome Measure | 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 two years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rezum, LUTS, B-TURP