One-year Results After Single-center Water Vapor Thermal Therapy for Symptomatic Benign Prostatic Hyperplasia.

NCT ID: NCT06257654

Last Updated: 2024-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

71 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-01-01

Study Completion Date

2023-12-31

Brief Summary

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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.

Detailed Description

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The data of participants who underwent Rezūm operation with the diagnosis of BPH between 2021 and 2023 were evaluated retrospectively. The investigators evaluated procedure details and evaluated pre- and post-Rezūm (including International Prostate Symptom Score (IPSS), IPSS quality of life (IPSS-QOL), prostate volumes, maximum flow (Qmax), post-void residual urine volume, IEEF-5, ejaculation dysfunction). The investigators examined variables at 6 and 12 months).

Conditions

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Prostatic Hyperplasia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

RETROSPECTIVE

Study Groups

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singel

REZUM

Intervention Type DEVICE

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

Interventions

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REZUM

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

-Benign prostatic hyperplasia

Exclusion Criteria

* Prostate cancer
* Parkinson's disease,
* Neurogenic bladder
* Overactive bladder
* Bladder calculus,
* Bladder Tumor
* Urinary infection
* Alzheimer's disease
Minimum Eligible Age

40 Years

Maximum Eligible Age

100 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hisar Intercontinental Hospital

OTHER

Sponsor Role lead

Responsible Party

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Basri Cakiroglu

Ass. Prof.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Basri Cakiroglu

Istanbul, , Turkey (Türkiye)

Site Status

Hisar Intercontinental Hospital

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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26.01.2024/24-2

Identifier Type: -

Identifier Source: org_study_id

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