Clinical trial NCT06818383: Comparative Study Between Rezum Therapy in Small and Large Prostates
Official title: Four-year Follow-up in Rezum Therapy of Small Prostates in Comparison with Large Prostates. a Prospective Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Hyperplasia
Keywords: Rezum
LUTS
Lead sponsor: Armed Forces College of Medicine, Cairo, Egypt
Sponsor class: OTHER
First posted: 2025-02-10
Enrollment: 178
Sex: MALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two groups
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Maximum Urinary flow rate (Qmax)
timeFrame: 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]
measure: The Quality of Life (QoL)
timeFrame: 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]
measure: The Prostatic specific antigen (PSA)
timeFrame: 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
measure: The International Prostate Symptom score (IPSS)
timeFrame: 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
measure: The International Index of Erectile Function (IIEF)
timeFrame: 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
measure: The Prostate size
timeFrame: 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
measure: The operative time
timeFrame: 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
measure: Incidence of The catheter duration post operative
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 4 years
measure: Post operative hospital stay time
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 4 years
measure: Post operative residual urine (PVR)
timeFrame: 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
Secondary outcomes:
measure: Incidence of complications
timeFrame: through four years
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: The Armed Forces College of Medicine (AFCM)
state: Nozha
Study officials:
name: Mohamed Samir Salem, MD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.