Clinical trial NCT06116370: The Clinical Efficacy of Rezūm Therapy Versus Bipolar Trans-urethral Resection of the Prostate for Treatment Benign Prostatic Hyperplasia
Official title: Two-Year Follow-Up Comparing Rezūm Therapy Versus Bipolar Transurethral Resection of the Prostate for Treating Benign Prostatic Hyperplasia. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostatic Hyperplasia
Keywords: Rezum
LUTS
B-TURP
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2023-11-03
Enrollment: 100
Sex: MALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Measurement of The International Prostate Symptom score (IPSS) in both groups
timeFrame: 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
measure: Measurement of The Quality of Life (QoL) in both groups
timeFrame: 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
measure: Measurement of The Maximum Urinary flow rate (Qmax) in both groups
timeFrame: 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
measure: Concentration of The Prostatic specific antigen (PSA) in both groups
timeFrame: 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
measure: Measurement of The International Index of Erectile Function (IIEF) in both groups
timeFrame: 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
measure: Measurement of The Prostate size
timeFrame: for each case in both groups the investigator assess prostate size at 24 months after procedures through study completion, an average of 2 years
measure: The operative time of both groups
timeFrame: 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
measure: Post operative hospital stay time in both groups
timeFrame: 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
measure: Incidence of The catheter duration post operative in both groups
timeFrame: 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
measure: Measurement of Post operative residual urine (PVR)
timeFrame: 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 outcomes:
measure: Incidence of complications
timeFrame: through two years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain Shams University
state: Abbassia
Study officials:
affiliation: Ain Shams University
name: mohamed sa salem, MD
role: STUDY_CHAIR
References:
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