Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06649357
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-17
Brief Title:
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Comparison Between Bipolar Transurethral Resection of the Prostate and Moses Assisted Holmium Laser Enucleation of the Prostate a Prospective Randomized Multicentric Study
Status:
NOT_YET_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:
Introduction Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay On the other hand no differences have been observed in terms of functional outcomes between both techniques and surgical times reported in different studies tend to be longer for HoLEP These results likely contribute to TURP especially with bipolar energy Bi-TURP continuing to be considered by many the gold standard for surgical treatment of BPH
Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017 delivered MOSES 20 a single-use laser fibre used to perform MOSES augmented HoLEP MoLEP MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP The availability of new morcellators might also decrease surgical time for HoLEP This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP
Primary Objective To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP
Secondary objectives
To compare the surgical time of MoLEP with that of Bi-TURP
To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP
To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP
To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP
This study is a prospective multicentric randomized and controlled trial The study compares two types of BPH surgery without changing standard medical practice
The study will include patients who are candidates according to standard medical practice for BPH surgery Patients will be randomized to one of two groups of treatment
The MoLEP group will receive surgical treatment with MoLEP
The Bi-TURP group will receive surgical treatment with Bi-TURP Surgical technique and postoperative care will follow standard clinical practice at each participating centre
Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017 delivered MOSES 20 a single-use laser fibre used to perform MOSES augmented HoLEP MoLEP MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP The availability of new morcellators might also decrease surgical time for HoLEP This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP
Primary Objective To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP
Secondary objectives
To compare the surgical time of MoLEP with that of Bi-TURP
To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP
To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP
To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP
This study is a prospective multicentric randomized and controlled trial The study compares two types of BPH surgery without changing standard medical practice
The study will include patients who are candidates according to standard medical practice for BPH surgery Patients will be randomized to one of two groups of treatment
The MoLEP group will receive surgical treatment with MoLEP
The Bi-TURP group will receive surgical treatment with Bi-TURP Surgical technique and postoperative care will follow standard clinical practice at each participating centre
Detailed Description:
Introduction The evolution of surgery for benign prostatic hyperplasia BPH has come a long way since Freyer described his technique of open adenomectomy over 100 years ago The advancement of instruments and surgical techniques has made surgery increasingly les invasive Transurethral resection of the prostate TURP allowed endoscopic treatment of BPH and it is still regarded by many as the gold-standard for BPH surgical treatment The application of Holmium laser for endoscopic enucleation of the prostate HoLEP in the last 20 years has allowed for the surgical treatment of BPH through an endoscopic approach practically without limitations in prostate size
Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay On the other hand no differences have been observed in terms of functional outcomes between both techniques and surgical times reported in different studies tend to be longer for HoLEP These results likely contribute to TURP especially with bipolar energy Bi-TURP continuing to be considered by many the gold standard for surgical treatment of BPH
However the available studies often have short follow-up periods most do not report on the surgeons experience with HoLEP and were based on early laser and morcellation technology Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017 delivered MOSES 20 a single-use laser fibre used to perform MOSES augmented HoLEP MoLEP MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP resulting in shorter enucleation haemostasis and total surgical times for similar energy delivered The availability of new morcellators might also decrease surgical time for HoLEP This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP
Hypothesis MoLEP surgery is superior to Bi-TURP in terms of postoperative stay bladder catheter duration blood loss and transfusion rate without significant functional outcomes and retreatment rate with no significant differences in surgical time
Objectives
Primary Objective To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP
Secondary objectives
To compare the surgical time of MoLEP with that of Bi-TURP
To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP
To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP
To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP
Study Design This study is a prospective multicentric randomized and controlled trial The study compares two types of BPH surgery without changing standard medical practice The CONSORT guidelines for randomized clinical trials will be followed
Participants Patients who are candidates according to standard medical practice for BPH surgery with a prostate volume 80 cc measured by urological ultrasound or magnetic resonance imaging MRI
Intervention The study will include patients who are candidates according to standard medical practice for BPH surgery Patients will be randomized to one of two groups of treatment
The MoLEP group will receive surgical treatment with MoLEP
The Bi-TURP group will receive surgical treatment with Bi-TURP Surgical technique and postoperative care will follow standard clinical practice at each participating centre
Surgery and Follow-up Schedule
Surgeries will be conducted between November 2024 and April 2025
Initial 6-month follow-up Database construction and refinement 2 months Statistical analysis 2 months Preparation of the final report 2 months Completion of the first phase of the study April 2026
Second phase follow-up 24 months Database construction and refinement 2 months Statistical analysis 2 months Preparation of the final report 2 months Dissemination of results 2 months Completion of the second phase of the study October 2027
Third phase follow-up 5 years Database construction and refinement 2 months Statistical analysis 2 months Preparation of the final report 2 months Dissemination of results 2 months Completion of the third phase of the study October 2030
Sample size calculation was calculated based on length of hospital stay Previous studies indicate that the mean days of hospital stay is around 25 days in patients with RTU The length of hospital stay for patients with MoLEP may be at least 1 day less Around 10 of patients are treated with antiplatelet agents In order to perform an analysis according to patients with and without this treatment the sample size will be increased by 10 Accepting an alpha risk of 5 and a beta risk of 20 in a two-tailed test a total of 130 patients are needed 65 in each study group A common standard deviation of 1 day is assumed A loss to follow-up rate of 12 has been also estimated
Statistical Analysis Qualitative variables will be described with absolute frequencies and percentages The description of quantitative variables will be performed using the mean standard deviation SD median and quartiles The Kolmogorov-Smirnov test will be used to assess the normality of distributions
An initial bivariate intention to treat analysis will be performed in order to analyze potential differences according study groups The relationship between two qualitative variables will be calculated using the chi-squared test or Fishers exact test frequency 5 Quantitative variables will be compared using the Students t-test Mann Whitney For non-normal distributions analysis of variance ANOVA 2 categories linear regression test and Scheas multiple comparisons test The linear relationship between the quantitative variables will be calculated using Pearsons correlation coefficient or Spearmans rank correlation test when variable not normally distributed Changes at the end of follow up in the main outcomes will be analyzed by Wilcoxon nonparametric test in the case of quantitative variables The McNemar test will be used for the comparison of categorical variables A backward stepwise linear regression analysis will be performed in order to determine which factors are independently associated to higher length of hospital stay Study groups and variables with a p value 02 in the univariate analysis will be included as independent variables The results will be described with beta coefficient 95 confidence interval CI and p-values For all the tests p-values 005 were considered statistically significant The statistical package R Studio V251 was used for the analyses
Publications will be made with the results of the study whether they are positive or negative There will be at least 3 publication scheduled This will be the results at 6 months 2 years and 5 years of follow up
Multiple studies have demonstrated the superiority of HoLEP in aspects such as transfusión rates or postoperative stay On the other hand no differences have been observed in terms of functional outcomes between both techniques and surgical times reported in different studies tend to be longer for HoLEP These results likely contribute to TURP especially with bipolar energy Bi-TURP continuing to be considered by many the gold standard for surgical treatment of BPH
However the available studies often have short follow-up periods most do not report on the surgeons experience with HoLEP and were based on early laser and morcellation technology Sofware and hardware upgrades to the Lumenis Pulse 120H system in 2017 delivered MOSES 20 a single-use laser fibre used to perform MOSES augmented HoLEP MoLEP MoLEP has shown to be superior in intraoperative outcomes when compared to traditional HoLEP resulting in shorter enucleation haemostasis and total surgical times for similar energy delivered The availability of new morcellators might also decrease surgical time for HoLEP This changing landscape for BPH endoscopic surgery deserves a re-evaluation of the differences between Bi-TURP and MoLEP
Hypothesis MoLEP surgery is superior to Bi-TURP in terms of postoperative stay bladder catheter duration blood loss and transfusion rate without significant functional outcomes and retreatment rate with no significant differences in surgical time
Objectives
Primary Objective To compare the hospital stay of patients of patients undergoing MoLEP with those undergoing Bi-TURP
Secondary objectives
To compare the surgical time of MoLEP with that of Bi-TURP
To compare the bladder catheterization time aCer MoLEP with that of Bi-TURP
To compare the postoperative complication rate patients undergoing MoLEP with those undergoing Bi-TURP
To compare functional results of patients undergoing MoLEP with those undergoing Bi-TURP
Study Design This study is a prospective multicentric randomized and controlled trial The study compares two types of BPH surgery without changing standard medical practice The CONSORT guidelines for randomized clinical trials will be followed
Participants Patients who are candidates according to standard medical practice for BPH surgery with a prostate volume 80 cc measured by urological ultrasound or magnetic resonance imaging MRI
Intervention The study will include patients who are candidates according to standard medical practice for BPH surgery Patients will be randomized to one of two groups of treatment
The MoLEP group will receive surgical treatment with MoLEP
The Bi-TURP group will receive surgical treatment with Bi-TURP Surgical technique and postoperative care will follow standard clinical practice at each participating centre
Surgery and Follow-up Schedule
Surgeries will be conducted between November 2024 and April 2025
Initial 6-month follow-up Database construction and refinement 2 months Statistical analysis 2 months Preparation of the final report 2 months Completion of the first phase of the study April 2026
Second phase follow-up 24 months Database construction and refinement 2 months Statistical analysis 2 months Preparation of the final report 2 months Dissemination of results 2 months Completion of the second phase of the study October 2027
Third phase follow-up 5 years Database construction and refinement 2 months Statistical analysis 2 months Preparation of the final report 2 months Dissemination of results 2 months Completion of the third phase of the study October 2030
Sample size calculation was calculated based on length of hospital stay Previous studies indicate that the mean days of hospital stay is around 25 days in patients with RTU The length of hospital stay for patients with MoLEP may be at least 1 day less Around 10 of patients are treated with antiplatelet agents In order to perform an analysis according to patients with and without this treatment the sample size will be increased by 10 Accepting an alpha risk of 5 and a beta risk of 20 in a two-tailed test a total of 130 patients are needed 65 in each study group A common standard deviation of 1 day is assumed A loss to follow-up rate of 12 has been also estimated
Statistical Analysis Qualitative variables will be described with absolute frequencies and percentages The description of quantitative variables will be performed using the mean standard deviation SD median and quartiles The Kolmogorov-Smirnov test will be used to assess the normality of distributions
An initial bivariate intention to treat analysis will be performed in order to analyze potential differences according study groups The relationship between two qualitative variables will be calculated using the chi-squared test or Fishers exact test frequency 5 Quantitative variables will be compared using the Students t-test Mann Whitney For non-normal distributions analysis of variance ANOVA 2 categories linear regression test and Scheas multiple comparisons test The linear relationship between the quantitative variables will be calculated using Pearsons correlation coefficient or Spearmans rank correlation test when variable not normally distributed Changes at the end of follow up in the main outcomes will be analyzed by Wilcoxon nonparametric test in the case of quantitative variables The McNemar test will be used for the comparison of categorical variables A backward stepwise linear regression analysis will be performed in order to determine which factors are independently associated to higher length of hospital stay Study groups and variables with a p value 02 in the univariate analysis will be included as independent variables The results will be described with beta coefficient 95 confidence interval CI and p-values For all the tests p-values 005 were considered statistically significant The statistical package R Studio V251 was used for the analyses
Publications will be made with the results of the study whether they are positive or negative There will be at least 3 publication scheduled This will be the results at 6 months 2 years and 5 years of follow up
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