Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656689
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-22
Brief Title:
Prospective Observational Study on Water Vapor Thermal Therapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Prospective Observational Study on Water Vapor Thermal Therapy in Management of Patients with Benign Prostatic Hyperplasia BPH
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients The main question it aims to answer is
Is Rezum an effective treatment
Is Rezum safe
Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety
Is Rezum an effective treatment
Is Rezum safe
Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety
Detailed Description:
1 Study Backgroud
The incidence and importance of benign prostatic hyperplasia BPH are rapidly increasing due to population aging westernized diets and a growing desire to improve the quality of life BPH is the most common cause of lower urinary tract symptoms LUTS in aging men and tends to progressively worsen over time The treatment of BPH focuses not only on improving symptoms but also on enhancing quality of life reducing the risks of surgery and acute urinary retention due to BPH and altering the natural course of the disease The primary treatment involves medications such as alpha-blockers androgen inhibitors and antimuscarinic agents However in cases of repeated acute urinary retention recurrent urinary tract infections bladder stones kidney function decline due to bladder outlet obstruction or recurrent hematuria caused by the prostate surgical intervention becomes necessary
Surgical methods for BPH include transurethral resection of the prostate TURP holmium laser enucleation of the prostate HoLEP robot-assisted simple prostatectomy RASP etc TURP developed in the 1920s remains the standard for BPH surgery effectively improving patient symptoms though it can cause retrograde ejaculation in 20-40 of cases and complications such as dilutional hyponatremia HoLEP has a lower recurrence rate than TURP and does not lead to complications like dilutional hyponatremia but it results in almost 100 incidence of retrograde ejaculation Robot-assisted prostatectomy offers a lower recurrence rate and allows for more complete removal of the adenoma but compared to endoscopic procedures it requires longer hospital stays has a longer recovery period and is more expensive
As alternatives to these surgeries various minimally invasive procedures have been developed to effectively improve symptoms while shortening hospital stays and minimizing complications Among them the Rezum procedure which will be studied in this research is one of the minimally invasive BPH treatments approved by the US FDA in 2015 This procedure involves injecting steam at 103C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate Compared to other minimally invasive procedures Rezum can be performed regardless of the prostates morphology and its simplicity is a significant advantage Several studies have already proven its safety and efficacy In South Korea Rezum was approved on January 25 2023 through the Ministry of Health and Welfare Notice No 2023-14 based on an evaluation of its safety and effectiveness as a new medical technology It was first introduced at St Vincents Hospital in July 2023 As no studies have been conducted on Korean patients with BPH this study aims to investigate the safety and efficacy of Rezum in Korean patients with BPH
2 Inclusion Exclusion Criteria
The study subjects are patients requiring surgery for benign prostatic hyperplasia BPH with the following inclusion and exclusion criteria
1 Inclusion Criteria Age 50 or older Prostate size between 30cc and 80cc as measured by transrectal ultrasound Patients scheduled for Rezum surgery for BPH
2 Exclusion Criteria Suspected prostate cancer Suspected urinary tract infection Inability to complete follow-up Patients who do not consent to participate in the study
3 Study Method
This study is a prospective cohort study without a control group All tests and surveys are part of the standard procedures already performed during typical surgeries for benign prostatic hyperplasia BPH and no additional tests or surveys will be conducted for research purposes Postoperative follow-up will also be conducted within the typical range of follow-up for BPH surgeries and there are no plans for additional follow-up specific to the study
Consent will be obtained from patients who require surgery for BPH and are scheduled to undergo surgery using the Rezum procedure Consent may be obtained either during the outpatient clinic visit when the surgery is decided or before the surgery during the patients hospital admission Consent will be obtained by the principal investigator or co-investigators
The surgery is performed with a same-day admission to the day-surgery unit and unless an additional hospitalization is necessary due to complications the patient is discharged on the same day A brief explanation of the Rezum procedure is as follows after local general or spinal anesthesia a cystoscope is inserted into the urethra and through the endoscope a needle is inserted into the enlarged part of the prostate to inject steam completing the surgery Patients are discharged with a urethral catheter and follow-up is done in the outpatient clinic one week later At the first follow-up after the catheter is removed the ability to void spontaneously is checked If there are no abnormalities follow-up can be conducted within 1-3 months at the discretion of the researcher and the following tests and surveys will be performed at a minimum of 3 months post-surgery
Data analysis will compare changes in symptom questionnaire scores prostate size on ultrasound prostate-specific antigen PSA levels maximum flow rate Qmax and post-void residual urine volume before and after surgery
4 Parameters
The following information will be collected
1 Preoperative Information Age Comorbidities American Society of Anesthesiologists ASA physical status classification system Presence of urethral catheter International Prostate Symptom Score IPSS International Index of Erectile Function IIEF Overactive Bladder Questionnaire-Short Form OAB-q Prostate size on ultrasound Prostate-Specific Antigen PSA Uroflowmetry Flow rate test Post-void residual volume PVR Urodynamic study
2 Intraoperative Information Surgery duration Anesthesia type Number of steam injections
3 Follow-up 3 months post-surgery International Prostate Symptom Score IPSS International Index of Erectile Function IIEF Overactive Bladder Questionnaire-Short Form OAB-q Prostate size on ultrasound Prostate-Specific Antigen PSA Uroflowmetry Flow rate test Post-void residual volume PVR Urodynamic study Complications within three months after surgery eg hematuria infection voiding dysfunction urethral catheter reinsertion Complications will be evaluated using the Clavien-Dindo classification
5 Statistical Analysis
All variables will be recorded using appropriate descriptive statistics Comparisons of continuous variables before and after surgery will be conducted using either a paired sample t-test or the Wilcoxon signed-rank test depending on the results of the normality test The continuous variables being compared are the International Prostate Symptom Score IPSS International Index of Erectile Function IIEF Overactive Bladder Questionnaire-Short Form OAB-q prostate size on ultrasound Prostate-Specific Antigen PSA maximum flow rate from uroflowmetry and post-void residual volume PVRA significance level of α005 will be used and a p-value of less than 005 will be interpreted as a statistically significant difference between the two groups
The incidence and importance of benign prostatic hyperplasia BPH are rapidly increasing due to population aging westernized diets and a growing desire to improve the quality of life BPH is the most common cause of lower urinary tract symptoms LUTS in aging men and tends to progressively worsen over time The treatment of BPH focuses not only on improving symptoms but also on enhancing quality of life reducing the risks of surgery and acute urinary retention due to BPH and altering the natural course of the disease The primary treatment involves medications such as alpha-blockers androgen inhibitors and antimuscarinic agents However in cases of repeated acute urinary retention recurrent urinary tract infections bladder stones kidney function decline due to bladder outlet obstruction or recurrent hematuria caused by the prostate surgical intervention becomes necessary
Surgical methods for BPH include transurethral resection of the prostate TURP holmium laser enucleation of the prostate HoLEP robot-assisted simple prostatectomy RASP etc TURP developed in the 1920s remains the standard for BPH surgery effectively improving patient symptoms though it can cause retrograde ejaculation in 20-40 of cases and complications such as dilutional hyponatremia HoLEP has a lower recurrence rate than TURP and does not lead to complications like dilutional hyponatremia but it results in almost 100 incidence of retrograde ejaculation Robot-assisted prostatectomy offers a lower recurrence rate and allows for more complete removal of the adenoma but compared to endoscopic procedures it requires longer hospital stays has a longer recovery period and is more expensive
As alternatives to these surgeries various minimally invasive procedures have been developed to effectively improve symptoms while shortening hospital stays and minimizing complications Among them the Rezum procedure which will be studied in this research is one of the minimally invasive BPH treatments approved by the US FDA in 2015 This procedure involves injecting steam at 103C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate Compared to other minimally invasive procedures Rezum can be performed regardless of the prostates morphology and its simplicity is a significant advantage Several studies have already proven its safety and efficacy In South Korea Rezum was approved on January 25 2023 through the Ministry of Health and Welfare Notice No 2023-14 based on an evaluation of its safety and effectiveness as a new medical technology It was first introduced at St Vincents Hospital in July 2023 As no studies have been conducted on Korean patients with BPH this study aims to investigate the safety and efficacy of Rezum in Korean patients with BPH
2 Inclusion Exclusion Criteria
The study subjects are patients requiring surgery for benign prostatic hyperplasia BPH with the following inclusion and exclusion criteria
1 Inclusion Criteria Age 50 or older Prostate size between 30cc and 80cc as measured by transrectal ultrasound Patients scheduled for Rezum surgery for BPH
2 Exclusion Criteria Suspected prostate cancer Suspected urinary tract infection Inability to complete follow-up Patients who do not consent to participate in the study
3 Study Method
This study is a prospective cohort study without a control group All tests and surveys are part of the standard procedures already performed during typical surgeries for benign prostatic hyperplasia BPH and no additional tests or surveys will be conducted for research purposes Postoperative follow-up will also be conducted within the typical range of follow-up for BPH surgeries and there are no plans for additional follow-up specific to the study
Consent will be obtained from patients who require surgery for BPH and are scheduled to undergo surgery using the Rezum procedure Consent may be obtained either during the outpatient clinic visit when the surgery is decided or before the surgery during the patients hospital admission Consent will be obtained by the principal investigator or co-investigators
The surgery is performed with a same-day admission to the day-surgery unit and unless an additional hospitalization is necessary due to complications the patient is discharged on the same day A brief explanation of the Rezum procedure is as follows after local general or spinal anesthesia a cystoscope is inserted into the urethra and through the endoscope a needle is inserted into the enlarged part of the prostate to inject steam completing the surgery Patients are discharged with a urethral catheter and follow-up is done in the outpatient clinic one week later At the first follow-up after the catheter is removed the ability to void spontaneously is checked If there are no abnormalities follow-up can be conducted within 1-3 months at the discretion of the researcher and the following tests and surveys will be performed at a minimum of 3 months post-surgery
Data analysis will compare changes in symptom questionnaire scores prostate size on ultrasound prostate-specific antigen PSA levels maximum flow rate Qmax and post-void residual urine volume before and after surgery
4 Parameters
The following information will be collected
1 Preoperative Information Age Comorbidities American Society of Anesthesiologists ASA physical status classification system Presence of urethral catheter International Prostate Symptom Score IPSS International Index of Erectile Function IIEF Overactive Bladder Questionnaire-Short Form OAB-q Prostate size on ultrasound Prostate-Specific Antigen PSA Uroflowmetry Flow rate test Post-void residual volume PVR Urodynamic study
2 Intraoperative Information Surgery duration Anesthesia type Number of steam injections
3 Follow-up 3 months post-surgery International Prostate Symptom Score IPSS International Index of Erectile Function IIEF Overactive Bladder Questionnaire-Short Form OAB-q Prostate size on ultrasound Prostate-Specific Antigen PSA Uroflowmetry Flow rate test Post-void residual volume PVR Urodynamic study Complications within three months after surgery eg hematuria infection voiding dysfunction urethral catheter reinsertion Complications will be evaluated using the Clavien-Dindo classification
5 Statistical Analysis
All variables will be recorded using appropriate descriptive statistics Comparisons of continuous variables before and after surgery will be conducted using either a paired sample t-test or the Wilcoxon signed-rank test depending on the results of the normality test The continuous variables being compared are the International Prostate Symptom Score IPSS International Index of Erectile Function IIEF Overactive Bladder Questionnaire-Short Form OAB-q prostate size on ultrasound Prostate-Specific Antigen PSA maximum flow rate from uroflowmetry and post-void residual volume PVRA significance level of α005 will be used and a p-value of less than 005 will be interpreted as a statistically significant difference between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None