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

Primary Purpose

Benign Prostatic Hyperplasia

Status

Active

Phase

Not Applicable

Locations

Egypt

Study Type

Interventional

Intervention

water vapor thermal therapy (Rezum) for prostate

About this trial

This is an interventional treatment trial for Benign Prostatic Hyperplasia

Eligibility Criteria

40 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Faculty of Medicine Helwan University

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

patient treated by rezum procedure

Arm Description

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

Outcomes

Primary Outcome Measures

prostate assessment

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

symptoms assessment

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

sexual function

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

durability of procedure

incidence of prostate retreatment by the same or other procedure.

complication of procedure

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

Full Information

NCT ID

NCT05982444

First Posted

July 24, 2023

Last Updated

August 1, 2023

Sponsor

Helwan University

1. Study Identification

Unique Protocol Identification Number

NCT05982444

Brief Title

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

Official Title

Long Term Post-operative Effectiveness and Morbidity of Rezum Therapy for Benign Prostatic Hyperplasia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Active, not recruiting

Study Start Date

January 1, 2020 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Helwan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Benign Prostatic Hyperplasia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

patient treated by rezum procedure

Arm Type

Other

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

water vapor thermal therapy (Rezum) for prostate

Other Intervention Name(s)

Prostate steam treatment (Rezum) for benign prostatic hyperplasia (BPH)

Intervention Description

all patients underwent rezum therapy for bph are evaluated for its effectiveness for long period

Primary Outcome Measure Information:

Title

prostate assessment

Description

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

Time Frame

4 years

Title

symptoms assessment

Description

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

Time Frame

4 years

Title

sexual function

Description

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

Time Frame

4 years

Secondary Outcome Measure Information:

Title

durability of procedure

Description

incidence of prostate retreatment by the same or other procedure.

Time Frame

4 years

Title

complication of procedure

Description

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

Time Frame

4 years

10. Eligibility

Sex

Male

Gender Based

Yes

Gender Eligibility Description

the disease is conclusive for men

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Facility Information:

Facility Name

Faculty of Medicine Helwan University

City

Helwan

State/Province

Cairo

ZIP/Postal Code

11795

Country

Egypt

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Patients are not permitted to post any of their personal information

Learn more about this trial

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

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