NCT06257654

Brief Summary

Objective: Rezūm vapor ablation is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezūm is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, it is unclear how effective Rezūm is for men in urinary retention. The investigators sought to determine whether Rezūm is effective in the treatment of catheter-dependent urinary retention secondary to BPH.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
71

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2024

Completed
19 days until next milestone

First Posted

Study publicly available on registry

February 14, 2024

Completed
Last Updated

February 15, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

January 26, 2024

Last Update Submit

February 14, 2024

Conditions

Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (3)

  • International Prostate Symptom Score,

    Scoring from 1-35, An increase in symptoms means an increase in the score, or a decrease in symptoms means a low score.

    1 years

  • quality of life index

    Scoring from 1-4, An increase in the quality of life means an increase in the score, or a decrease in the quality of life means a decrease in the score.

    1 years

  • q max

    ml/sn

    1 years

Study Arms (1)

singel

Device: REZUM

Interventions

REZUMDEVICE

The 3rd and 12th month follow-ups of the patients who underwent REZUM operation were evaluated.

singel

Eligibility Criteria

Age40 Years - 100 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsmale patients with prostate symptoms
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

male patients with prostate symptoms

You may qualify if:

  • Benign prostatic hyperplasia

You may not qualify if:

  • Prostate cancer
  • Parkinson's disease,
  • Neurogenic bladder
  • Overactive bladder
  • Bladder calculus,
  • Bladder Tumor
  • Urinary infection
  • Alzheimer's disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Basri Cakiroglu

Istanbul, 34768, Turkey (Türkiye)

Location

Hisar Intercontinental Hospital

Istanbul, 34768, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ass. Prof.

Study Record Dates

First Submitted

January 26, 2024

First Posted

February 14, 2024

Study Start

January 1, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2023

Last Updated

February 15, 2024

Record last verified: 2024-02

Locations

TU(2)