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

NCT06116370 | Completed

• 1 other identifier: surgical treatments of BPH
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostatic Hyperplasia

Keywords

Rezum; LUTS; B-TURP

Outcome Measures

Primary Outcomes (10)

• 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 Outcomes (1)

• Incidence of complications

  through two years

Study Arms (2)

BPH patients treated with Rezum procedure

ACTIVE COMPARATOR

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

BPH patients treated with B-TURP procedure

ACTIVE COMPARATOR

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

Interventions

Rezum procedure PROCEDURE

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.

BPH patients treated with Rezum procedure

B-TURP procedure PROCEDURE

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.

BPH patients treated with B-TURP procedure

Eligibility Criteria

• Age: 50 Years - 80 Years
• Gender Eligibility Details: disease specific to men
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• prostate cancer
• Neurogenic bladder
• urethral stricture
• urinary bladder stone
• previous prostatic surgery.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University

Cairo, Abbassia, 11566, Egypt

Location

Related Publications (9)

• 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.

  PMID: 27921028 BACKGROUND

• Elshal AM, Soltan M, El-Tabey NA, Laymon M, Nabeeh A. Randomised trial of bipolar resection vs holmium laser enucleation vs Greenlight laser vapo-enucleation of the prostate for treatment of large benign prostate obstruction: 3-years outcomes. BJU Int. 2020 Dec;126(6):731-738. doi: 10.1111/bju.15161. Epub 2020 Sep 30.

  PMID: 32633020 BACKGROUND

• Samir M, Tawfick A, Mahmoud MA, Elawady H, Abuelnaga M, Shabayek M, Youssef AEH, Tawfeek AM. Two-year Follow-up in Bipolar Transurethral Enucleation and Resection of the Prostate in Comparison with Bipolar Transurethral Resection of the Prostate in Treatment of Large Prostates. Randomized Controlled Trial. Urology. 2019 Nov;133:192-198. doi: 10.1016/j.urology.2019.07.029. Epub 2019 Aug 9.

  PMID: 31404581 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.

  PMID: 30677455 BACKGROUND

• Parsons JK, Dahm P, Kohler TS, Lerner LB, Wilt TJ. Surgical Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia: AUA Guideline Amendment 2020. J Urol. 2020 Oct;204(4):799-804. doi: 10.1097/JU.0000000000001298. Epub 2020 Jul 23.

  PMID: 32698710 BACKGROUND

• Nickel JC, Aaron L, Barkin J, Elterman D, Nachabe M, Zorn KC. Canadian Urological Association guideline on male lower urinary tract symptoms/benign prostatic hyperplasia (MLUTS/BPH): 2018 update. Can Urol Assoc J. 2018 Oct;12(10):303-312. doi: 10.5489/cuaj.5616. No abstract available.

  PMID: 30332601 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.

  PMID: 32408768 BACKGROUND

• Garden EB, Shukla D, Ravivarapu KT, Kaplan SA, Reddy AK, Small AC, Palese MA. Rezum therapy for patients with large prostates (>/= 80 g): initial clinical experience and postoperative outcomes. World J Urol. 2021 Aug;39(8):3041-3048. doi: 10.1007/s00345-020-03548-7. Epub 2021 Jan 3.

  PMID: 33392646 BACKGROUND

• Elterman D, Bhojani N, Vannabouathong C, Chughtai B, Zorn KC. Rezum therapy for >/=80-mL benign prostatic enlargement: a large, multicentre cohort study. BJU Int. 2022 Oct;130(4):522-527. doi: 10.1111/bju.15753. Epub 2022 May 7.

  PMID: 35466513 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• mohamed sa salem, MD

  Ain Shams University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: November 3, 2023
• Study Start: June 1, 2021
• Primary Completion: June 1, 2023
• Study Completion: September 1, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)