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The Use of REZUM System in Chinese Male Patients With LUTS Secondary to Benign Prostate Enlargement

NCT04340934 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2021-06-04

No results posted yet for this study

Summary

Men with enlarged prostates commonly experience lower urinary tract symptoms and may go on to develop complications such as acute urinary retention (AUR). Surgery is the standard treatment option required to remove the enlarged prostates and to rectify such complications. Transurethral resection of prostate (TURP) was first performed over 80 years ago and is still regarded as the "gold standard" for the treatment of benign prostatic enlargement (BPE) in prostates between 30 and 80ml. While TURP results in an improvement in symptoms, perioperative morbidity and long-term complications can include postoperative bleeding, urinary retention, incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction. Rezūm is a system uses water steam energy to remove the particular part of the prostate that enlarges and causes symptoms due to BPH. Rezum involves a radiofrequency (RF) generator system and an endoscopic device that is introduced into the body via the urethra. Radiofrequency energy from the generator will heat up a controlled amount of water inside the system and converting the water into vapour or steam. The thermal energy created outside the body is delivered into the prostate tissue through the tiny needle at the tip of the endoscopic device. Small amount of steam will then be injected into the tissue and energy will be released during the conversion of steam to water. The energy will heat up the prostate tissue and result in gradually removal of the targeted obstructive prostate tissue. The treatment procedure takes approximately 3-7 minutes and can be performed as day surgery. No radiofrequency energy is delivered into the body, other than the prostate. Throughout the procedure normal saline (salty water) is running into the urethra through the scope to help ensure better views and to prevent the urethra from overheating. Voiding symptom will gradually improve after the procedure. From clinical study based in Caucasian population, patients had improved urinary flow rate by on average 50% and also improvement in quality of life scores. The treatment results could last for at least 4 years. However, information regarding the use of Rezum in Chinese and Asian is lacking. This study is proposed to evaluate the efficacy and safety of Rezum in our population.

Conditions

  • Benign Prostatic Hyperplasia

Interventions

DEVICE

REZUM system

Rezūm is a system uses water steam energy to remove the particular part of the prostate that enlarges and causes symptoms due to BPH. Rezum involves a radiofrequency (RF) generator system and an endoscopic device that is introduced into the body via the urethra.

Sponsors & Collaborators

  • Chinese University of Hong Kong

    lead OTHER

Principal Investigators

  • Chi Fai NG, MD · Chinese University of Hong Kong

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-13
Primary Completion
2021-01-29
Completion
2021-01-29

Countries

  • Hong Kong

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04340934 on ClinicalTrials.gov