The Use of REZUM System in Chinese Male Patients With LUTS Secondary to Benign Prostate Enlargement
The Use of REZUM System in Chinese Male Patients With LUTS Secondary to Benign Prostate Enlargement
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.
Benign prostatic enlargement (BPE) is a non-malignant growth of the prostate gland that can
 lead to a range of lower urinary tract symptoms (LUTS), and in some cases eventually leading
 to retention of urine. In patients failing to wean off catheter after retention of urine due
 to BPE, surgical intervention is the standard treatment.

 Surgical intervention options have evolved from electrosurgical resection to the use of
 lasers for enucleation and ablation [1]. Transurethral resection of prostate (TURP) was first
 performed over 80 years ago and is still regarded as the "gold standard" for the treatment of
 BPE in prostates between 30 and 80ml [2]. While TURP results in a statistically significant
 improvement in symptoms score and and maximum urinary flow rate (Qmax), perioperative
 morbidity and long-term complications can include postoperative bleeding, urinary retention,
 incontinence, urethral strictures, erectile dysfunction, and ejaculatory dysfunction [3].

 Rezum system use the principle of thermodynamic principle of convective energy transfer,
 which is different to other conductive heat transfer techniques like transurethral microwave
 therapy or transurethral needle ablation. [4] In the Rezum system, radiofrequency power is
 used to create thermal energy in the form of water vapor, which in turn deposits the stored
 thermal energy during the change from steam phase to liquid after injected into the prostatic
 tissue. The Rezum system contained a generator with a radiofrequency power supply to create
 water vapor from sterile water and a single-use transurethral delivery device. The tip of the
 delivery device contains an 18-gauge needle where 12 small emitter holes spaced
 circumferentially for dispersion of water vapor into the targeted prostatic tissue. The
 injection is at a pressure slightly higher than interstitial pressure. Due to the convective
 properties of water vapor, the injected steam will disperse rapidly and homogenously through
 the tissue and releases stored thermal energy into prostatic tissue. The released thermal
 energy will cause tissue necrosis. The most important character of the treatment is when the
 transition zone is treated, its energy will only deposit within the zonal anatomy of the
 prostate. Studies by histologic and MRI imaging had shown that after treatment, the thermal
 lesions were only limited to the transition zone without extension to the peripheral zone,
 bladder, rectum or striated urinary sphincter [5,6]. It was shown that 6 mo after treatment
 the total prostate volume was reduced by 28.9% and the resolution of thermal lesions as
 determined with Gadolini- um-enhanced magnetic resonance imaging was almost complete. [6] A
 small pilot study had shown that Rezum could provide safe and effective treatment upto one
 year for men with LUTS due to BPE. [7] In the first multicentre, randomised, controlled study
 197 men were enrolled and randomised in a 2:1 ratio to treatment with the Rezum system or
 control. [8] The sham procedure (control) was rigid cystoscopy with imitated treatment
 sounds. The primary efficacy end point was met at 3 months with relief of symptoms measured
 by a change in International prostate symptom score (IPSS) of 50% for the treatment arm
 compared to 20% for the control group (p < 0.0001). In the thermal treatment arm, the maximal
 uroflow rate increased significantly by 67% from 9.9 ml/s to 16.1 ml/s (p < 0.0001) after 3
 months. The clinical beneficial outcome was sustained throughout the study period with an
 improvement of 54% at the 12-mo follow up. In the latest updated report on the 4-year
 outcome, the improvement in voiding (as measured by IPSS and uroflowmetry) was sustained to 4
 years with surgical retreatment rate of only 4.4%. [9] Therefore, Rezum was proven to be an
 effective treatment for BPH.

 However, all studies focused on the application of Rezum in patients with LUTS are from
 Caucasian population. Therefore, in this study, investigator plan to evaluate the feasibility
 and safety of Rezum in the management of Chinese male patients with LUTS secondary to BPE.
 This could provide information on the tolerability and effectiveness of the treatment in
 local population.
Inclusion Criteria:

 -  Men aged between 50 - 80 years

 -  clinically indicated for surgical treatment

 Exclusion Criteria:

 -  Patients with active urinary tract infection or in retention of urine

 -  Patients with bleeding disorder or on anti-coagulation

 -  Patients with bladder pathology including bladder stone and bladder cancer

 -  Patients with urethral stricture

 -  Patients with neurogenic bladder and/or sphincter abnormalities

 -  Patients with previous nonpharmacological prostate treatment, Prostate cancer

 -  Fail to give informed consent