Comparative Study Between Rezum Therapy in Small and Large Prostates

NCT06818383 | Completed

• 1 other identifier: Rezum therapy in prostate
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Hyperplasia

Keywords

Rezum; LUTS

Outcome Measures

Primary Outcomes (10)

• 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)

  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

Secondary Outcomes (1)

• Incidence of complications

  through four years

Study Arms (2)

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

Device: Rezum therapy

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

Device: Rezum therapy

Interventions

Rezum therapy DEVICE

minimal invasive technique for treating BPH

BPH patients have large prostates treated with Rezum; BPH patients have small prostates treated with Rezum

Eligibility Criteria

• Age: 45 Years - 75 Years
• Gender Eligibility Details: because the prostates in males only
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• prostate size 45-75 gm
• sexually active
• mod - sever LUTS
• Q max \< 15
• IPSS \> 15
• failed medical treatment with alpha blockers

You may not qualify if:

• neurogenic bladder
• urethral stricture
• UB stones
• cancer prostate

Sponsors & Collaborators

• khaled Abdelsattar Gad Ibrahim: lead

Study Sites (1)

The Armed Forces College of Medicine (AFCM)

Cairo, Nozha, 4470351, Egypt

Location

Related Publications (3)

• 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

• 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

• 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

Related Links

• efficay of Rezum tehrapy in large prostates

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Mohamed Samir Salem, MD

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: consultatnt doctor

Model Details: two groups

Study Record Dates

• First Submitted: February 5, 2025
• First Posted: February 10, 2025
• Study Start: January 1, 2021
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 12, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)