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Long Term Follow up of Water Vapor Thermal Therapy (Rezum) for Benign Prostatic Hyperplasia (BPH)

Sponsor
Helwan University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT05982444
Collaborator
(none)
50
Enrollment
1
Location
1
Arm
47
Anticipated Duration (Months)
1.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

in this study the investigators are assessing the effectiveness and morbidity of rezum therapy for benign prostatic hyperplasia by collect data and assess all patient who treated by rezum from 2 to 4 years and report these results.

Condition or Disease Intervention/Treatment Phase
  • Procedure: water vapor thermal therapy (Rezum) for prostate
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia
Actual Study Start Date :
Jan 1, 2020
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Other: patient treated by rezum procedure

patients had benign prostatic hyperplasia and treated by rezum procedure from 2 to 4 years included in the study

Procedure: water vapor thermal therapy (Rezum) for prostate
all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period
Other Names:
  • Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. prostate assessment [4 years]

      assess prostate volume and post voiding residual by pelvi-abdominal ultrasound

    2. symptoms assessment [4 years]

      assess International Prostate Symptom Score (IPSS) from 0 to 7 mild symptoms - from 8 to 19 moderate symptoms and from 20 to 35 sever symptoms

    3. sexual function [4 years]

      assess international index of erectile function ( IIEF-5) score (5-7) severe - (8-11) moderate - (12-16) mild to moderate - (17-21) mild - (22-25) no erectile dysfunction

    Secondary Outcome Measures

    1. durability of procedure [4 years]

      incidence of prostate retreatment by the same or other procedure.

    2. complication of procedure [4 years]

      incidence of urological complications (e.g. urine retention, urethral stricture and hematuria) happen during follow up

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    40 Years to 80 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • patients underwent rezum procedure for benign prostatic hyperplasia from 2 to 4 years
    Exclusion Criteria:

    • previous prostatic intervention

    • concurrent urological morbidity like urethral stricture

    • neurological disease like parkinson's disease

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Medicine Helwan University Helwan Cairo Egypt 11795

    Sponsors and Collaborators

    • Helwan University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mahmoud Mohammed Elsaid Ali Elshahawy, Principal Investigator, Helwan University
    ClinicalTrials.gov Identifier:
    NCT05982444
    Other Study ID Numbers:
    • 30-2023
    First Posted:
    Aug 8, 2023
    Last Update Posted:
    Aug 8, 2023
    Last Verified:
    Aug 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Prostatic Hyperplasia
    Hyperplasia

    Study Results

    No Results Posted as of Aug 8, 2023