CI

At a glance

ClinicalIndex Comparison Record
N/ATerminated· 3 enrolled
Drug / intervention
REZUM systemdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04340934
NCT04340934N/ATerminated
Terminated

The Use of REZUM System in Chinese Male Patients With Lower Urinary Tract Symptom Secondary to Benign Prostate Enlargement

Chinese University of Hong Kong·interventional·Posted Apr 10, 2020·Updated Jun 4, 2021

In Brief

A clinical study evaluating REZUM system for Benign Prostatic Hyperplasia. Terminated early, enrolled 3 participants across 1 site.

Signals

Trial was terminated early

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesHong Kong
Collaborators--

Timeline

N/ATerminatedFinished
202120222023202420252026
First PostedApr 10, 2020
Enrollment StartMay 13, 2020
Primary CompletionJan 29, 2021
TodayJul 1, 2026
Enrollment to primary: 9 monthsPosted 6.2 years ago

Interventions

REZUM systemdevice

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.