Comparative Study Between Rezum Therapy in Small and Large Prostates

February 8, 2025 updated by: khaled Abdelsattar Gad Ibrahim

Four-year Follow-up in Rezum Therapy of Small Prostates in Comparison with Large Prostates. a Prospective Trial

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • Nozha
      • Cairo, Nozha, Egypt, 4470351
        • The Armed Forces College of Medicine (AFCM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: BPH patients have small prostates treated with Rezum
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
minimal invasive technique for treating BPH
Active Comparator: BPH patients have large prostates treated with Rezum
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
minimal invasive technique for treating BPH

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Maximum Urinary flow rate (Qmax)
Time Frame: 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]
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)
Time Frame: 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]
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)
Time Frame: 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
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)
Time Frame: 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
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)
Time Frame: 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
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
Time Frame: 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 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
Time Frame: 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
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
Time Frame: 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
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
Time Frame: 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
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)
Time Frame: 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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of complications
Time Frame: through four years
For each case in both groups the investigator assess the safety using incidence of complications by The Clavien-Dindo system
through four years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

khaled Abdelsattar Gad Ibrahim

Investigators

  • Study Chair: Mohamed Samir Salem, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2021

Primary Completion (Actual)

January 1, 2025

Study Completion (Actual)

February 1, 2025

Study Registration Dates

First Submitted

February 5, 2025

First Submitted That Met QC Criteria

February 7, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 8, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Rezum therapy in prostate

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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