Benign Prostatic HyperplasiaNCT04340934
The Use of REZUM System in Chinese Male Patients With LUTS Secondary to Benign Prostate Enlargement
A study testing REZUM system in people with Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- REZUM system
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteHong Kong
- Study dates
- 13 May 2020to 29 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men aged between 50 - 80 years
- clinically indicated for surgical treatment
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of REZUM System in Chinese Male Patients With Lower Urinary Tract Symptom 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.
Read the detailed description
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.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- REZUM system
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Use of REZUM system | Experimental | Surgery of benign prostatic hyperplasia by REZUM system Receives: Device: REZUM system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment
IPSS score ranging from 0-35 (the higher the worse)
Measured: at baseline, 6 months after study intervention
Secondary outcomes (9)
Complications rate
Complications rate after study intervention
Measured: 30 days after study intervention
Post-op total score in International Prostate Symptom Score (IPSS)
Change in total score of IPSS, score ranging from 0-35 (the higher the worse)
Measured: At 3 months, 6 months and 12 months after study intervention
Post-op quality of life score
Change in quality of life assessed by change in International Prostate QOL score (ranges from 0 to 6, the higher the worse)
Measured: At 3 months, 6 months and 12 months after study intervention
Post-op International Index of Erectile Function 5 (IIEF-5) score
Change in total score of International Index of Erectile Function 5 score (ranges from 0 to 25)
Measured: At 3 months, 6 months and 12 months after study intervention
Post-op Overactive bladder symptom score (OABSS) score
Change in total score of Overactive Bladder Symptom Score (ranges from 0 - 15, the higher the worse)
Measured: At 3 months, 6 months and 12 months after study intervention
Post-op pain score
Post-treatment pain score ranges from 0 to 10
Measured: Day 0, on the day of study intervention
Change in voiding function in uroflowmetry
It is assessed by maximum flow rate in uroflowmetry
Measured: At baseline, 3 months, 6 months and 12 months after study intervention
Change in urodynamic
Change in urodynamic function assessed by flowrate
Measured: At baseline, 3 months, 6 months and 12 months after study intervention
Change in prostate size
Prostate size is assessed by transrectal ultrasound of prostate
Measured: At baseline, 3 months, 6 months and 12 months after study intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start13 May 2020
- Primary completion29 Jan 2021
- Study completion29 Jan 2021
Why it stopped: Due to funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chi Fai NG, Chinese University of Hong Kong
- Investigators
- Chi Fai NG, MD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340934
- Sponsor's protocol ID
- CRE-2019.662
- Status last verified
- Jun 2021
- First submitted
- 8 Apr 2020
- Last updated
- 4 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stepanova LA. Comparative evaluation of two methods of calculating zooplankton production exemplified on the Lake Il'men population. Sov J Ecol. 1974 Sep;4(6):476-82. No abstract available.
PubMed 4445912Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
PubMed 25613154Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.
PubMed 16469429Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C. Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.
PubMed 28734706Dixon CM, Rijo Cedano E, Mynderse LA, Larson TR. Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezum((R)) system: evaluation of acute ablative capabilities in the human prostate. Res Rep Urol. 2015 Jan 30;7:13-8. doi: 10.2147/RRU.S74040. eCollection 2015.
PubMed 25674555Mynderse LA, Hanson D, Robb RA, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Cedano ER, Woodrum DA, Dixon CM, Larson TR. Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: Validation of Convective Thermal Energy Transfer and Characterization With Magnetic Resonance Imaging and 3-Dimensional Renderings. Urology. 2015 Jul;86(1):122-7. doi: 10.1016/j.urology.2015.03.021. Epub 2015 May 16.
PubMed 25987496Dixon C, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Mynderse L, Larson T. Efficacy and Safety of Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urology. 2015 Nov;86(5):1042-7. doi: 10.1016/j.urology.2015.05.046. Epub 2015 Jul 26.
PubMed 26216644McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
PubMed 26614889McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
PubMed 30677455Cantrill CH, Zorn KC, Elterman DS, Gonzalez RR. The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia. Can J Urol. 2019 Jun;26(3):9787-9793.
PubMed 31180311
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of REZUM System in Chinese Male Patients With Lower Urinary Tract Symptom Secondary to Benign Prostate Enlargement
- ClinicalTrials.gov ID
- NCT04340934
- Acronym / sponsor ID
- CRE-2019.662
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to funding
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 29 Jan 2021 (actual)
- Study completion
- 29 Jan 2021 (actual)
- First posted
- 10 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Use of REZUM system | Experimental | Device: REZUM systemSurgery of benign prostatic hyperplasia by REZUM system |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men aged between 50 - 80 years
- clinically indicated for surgical treatment
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REZUM systemRezūm 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. | Device | Use of REZUM system |
Primary outcome
Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment
Time frame: at baseline, 6 months after study intervention
IPSS score ranging from 0-35 (the higher the worse)
9 secondary outcomes
Complications rate
Time frame: 30 days after study intervention
Post-op total score in International Prostate Symptom Score (IPSS)
Time frame: At 3 months, 6 months and 12 months after study intervention
Post-op quality of life score
Time frame: At 3 months, 6 months and 12 months after study intervention
Post-op International Index of Erectile Function 5 (IIEF-5) score
Time frame: At 3 months, 6 months and 12 months after study intervention
Post-op Overactive bladder symptom score (OABSS) score
Time frame: At 3 months, 6 months and 12 months after study intervention
Post-op pain score
Time frame: Day 0, on the day of study intervention
Change in voiding function in uroflowmetry
Time frame: At baseline, 3 months, 6 months and 12 months after study intervention
Change in urodynamic
Time frame: At baseline, 3 months, 6 months and 12 months after study intervention
Change in prostate size
Time frame: At baseline, 3 months, 6 months and 12 months after study intervention
Results and safety
The study was stopped early (reason given: Due to funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2021.
- Background: PubMed 4445912Stepanova LA. Comparative evaluation of two methods of calculating zooplankton production exemplified on the Lake Il'men population. Sov J Ecol. 1974 Sep;4(6):476-82. No abstract available.
- Background: PubMed 25613154Gratzke C, Bachmann A, Descazeaud A, Drake MJ, Madersbacher S, Mamoulakis C, Oelke M, Tikkinen KAO, Gravas S. EAU Guidelines on the Assessment of Non-neurogenic Male Lower Urinary Tract Symptoms including Benign Prostatic Obstruction. Eur Urol. 2015 Jun;67(6):1099-1109. doi: 10.1016/j.eururo.2014.12.038. Epub 2015 Jan 19.
- Background: PubMed 16469429Rassweiler J, Teber D, Kuntz R, Hofmann R. Complications of transurethral resection of the prostate (TURP)--incidence, management, and prevention. Eur Urol. 2006 Nov;50(5):969-79; discussion 980. doi: 10.1016/j.eururo.2005.12.042. Epub 2006 Jan 30.
- Background: PubMed 28734706Magistro G, Chapple CR, Elhilali M, Gilling P, McVary KT, Roehrborn CG, Stief CG, Woo HH, Gratzke C. Emerging Minimally Invasive Treatment Options for Male Lower Urinary Tract Symptoms. Eur Urol. 2017 Dec;72(6):986-997. doi: 10.1016/j.eururo.2017.07.005. Epub 2017 Jul 19.
- Background: PubMed 25674555Dixon CM, Rijo Cedano E, Mynderse LA, Larson TR. Transurethral convective water vapor as a treatment for lower urinary tract symptomatology due to benign prostatic hyperplasia using the Rezum((R)) system: evaluation of acute ablative capabilities in the human prostate. Res Rep Urol. 2015 Jan 30;7:13-8. doi: 10.2147/RRU.S74040. eCollection 2015.
- Background: PubMed 25987496Mynderse LA, Hanson D, Robb RA, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Cedano ER, Woodrum DA, Dixon CM, Larson TR. Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms/Benign Prostatic Hyperplasia: Validation of Convective Thermal Energy Transfer and Characterization With Magnetic Resonance Imaging and 3-Dimensional Renderings. Urology. 2015 Jul;86(1):122-7. doi: 10.1016/j.urology.2015.03.021. Epub 2015 May 16.
- Background: PubMed 26216644Dixon C, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Mynderse L, Larson T. Efficacy and Safety of Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urology. 2015 Nov;86(5):1042-7. doi: 10.1016/j.urology.2015.05.046. Epub 2015 Jul 26.
- Background: PubMed 26614889McVary KT, Gange SN, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Rousseau M, Beahrs JR, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Larson TR, Dixon CM, Roehrborn CG. Minimally Invasive Prostate Convective Water Vapor Energy Ablation: A Multicenter, Randomized, Controlled Study for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2016 May;195(5):1529-1538. doi: 10.1016/j.juro.2015.10.181. Epub 2015 Nov 22.
- Background: PubMed 30677455McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.
- Background: PubMed 31180311Cantrill CH, Zorn KC, Elterman DS, Gonzalez RR. The Rezum system - a minimally invasive water vapor thermal therapy for obstructive benign prostatic hyperplasia. Can J Urol. 2019 Jun;26(3):9787-9793.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chi Fai NG, MD principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing REZUM system in people with Benign Prostatic Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 4 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Due to funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in International Prostate Symptom Score (IPSS) at 6 months after treatment (time frame: at baseline, 6 months after study intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04340934, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2021.