Ignite Creation Date:
2024-05-06 @ 12:10 AM
Last Modification Date:
2024-10-26 @ 10:45 AM
Study NCT ID:
NCT01500603
Status:
TERMINATED
Last Update Posted:
2014-10-08
First Post:
2011-12-23
Brief Title:
Periurethral Pro-ACTTM Balloons vs Retrourethral AdvanceXPTM Male Sling for Post-prostatectomy Incontinence
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Prospective Randomized Multicentric Comparative Trial of Two Devices in Surgical Treatment of Post-radical Prostatectomy Stress Urinary Incontinence Periurethral Pro-ACTTM Balloons and AdvanceXPTM Retrourethral Male Sling
Status:
TERMINATED
Status Verified Date:
2014-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of inclusion in the study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BALLANCE
Brief Summary:
Background Periurethral Pro-ACT balloons and retrourethral AdvanceXPTM male sling have been presented as efficient treatments for management of stress urinary incontinence SUI following radical prostatectomy RP but no comparative study of these two techniques has been published The investigators aims were to compare the efficacy of the two devices and provide data about their cost effectiveness
Hypothesis The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up
Primary objective The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up
Secondary objectives
Comprehensive comparative medical evaluation of the two devices in terms of efficacy
Complete evaluation of the side effects of the two techniques
Evaluation of the quality of life
Evaluation of patient satisfaction
Cost-effectiveness study of the device total cost over one year of each of the two techniques differential cost-effectiveness ratio cost adjusted by QALY differential cost-effectiveness ratio in terms adjusted to success rate recommendations that can be made for assessing the potential coverage by the French healthcare system Population Patients with history of RP without cancer recurrence presenting pure SUI on urodynamics without detrusor overactivity of mild to moderate degree 24hour pad-test 300g
Study design This is a prospective randomized multicentric 9 tertiary reference centers comparative trial of the two devices with a superiority hypothesis The total number of subjects required is 240 and inclusion period is 12 months Follow-up consists in 4 visits at 1 3 6 and 12 months with data collection pad use uroflowmetry quality of life validated questionnaires ICIQ-SF and EQ-5D 24-hr pad test patient satisfaction with PGI-I and report of any secondary effect Statistical evaluation is carried out at the end of the follow-up in intent to treat
Medical evaluation
Main criterionfailure of the treatment defined by reduction of less than 50 of incontinence on 24-hr pad test explantation of the device or implantation of a new surgical device for SUI
Secondary outcome criteria
pad usage per day
quantitative reduction of the 24hr-pad test
complications infection erosion hematoma acute urinary retention
number of re-interventions or re-admissions during follow-up
quality of life measured by the ICIQ-SF questionnaire
patient satisfaction by the PGI-I questionnaire
Economic evaluation
Study of the total cost over one year in each case
Adjustment of cost of each device to quality of life QALY evaluation
Cost effectiveness study
Proposals will be made to state at which level the two devices should be covered by the healthcare system
Hypothesis The study is based on the superiority hypothesis that AdvanceXP male slings is more efficacious than Pro-ACT balloons at one year follow-up
Primary objective The primary objective of this study is to compare the efficacy of the AdvanceXP retrourethral male sling and periurethral Pro-ACT balloons management of SUI after RP at one year follow-up
Secondary objectives
Comprehensive comparative medical evaluation of the two devices in terms of efficacy
Complete evaluation of the side effects of the two techniques
Evaluation of the quality of life
Evaluation of patient satisfaction
Cost-effectiveness study of the device total cost over one year of each of the two techniques differential cost-effectiveness ratio cost adjusted by QALY differential cost-effectiveness ratio in terms adjusted to success rate recommendations that can be made for assessing the potential coverage by the French healthcare system Population Patients with history of RP without cancer recurrence presenting pure SUI on urodynamics without detrusor overactivity of mild to moderate degree 24hour pad-test 300g
Study design This is a prospective randomized multicentric 9 tertiary reference centers comparative trial of the two devices with a superiority hypothesis The total number of subjects required is 240 and inclusion period is 12 months Follow-up consists in 4 visits at 1 3 6 and 12 months with data collection pad use uroflowmetry quality of life validated questionnaires ICIQ-SF and EQ-5D 24-hr pad test patient satisfaction with PGI-I and report of any secondary effect Statistical evaluation is carried out at the end of the follow-up in intent to treat
Medical evaluation
Main criterionfailure of the treatment defined by reduction of less than 50 of incontinence on 24-hr pad test explantation of the device or implantation of a new surgical device for SUI
Secondary outcome criteria
pad usage per day
quantitative reduction of the 24hr-pad test
complications infection erosion hematoma acute urinary retention
number of re-interventions or re-admissions during follow-up
quality of life measured by the ICIQ-SF questionnaire
patient satisfaction by the PGI-I questionnaire
Economic evaluation
Study of the total cost over one year in each case
Adjustment of cost of each device to quality of life QALY evaluation
Cost effectiveness study
Proposals will be made to state at which level the two devices should be covered by the healthcare system
Detailed Description:
Background Stress urinary incontinence SUI is a common adverse event of radical prostatectomy RP for localized prostate cancer and can dramatically impact quality of life Management of SUI after RP is based on conservative measures and pelvic floor muscle training In case of failure of this first line therapy surgical treatment is required In recent years periurethral Pro-ACT balloons and retrourethral AdvanceXP male sling have been proven to be efficient to manage SUI after RP in case of mild to moderate symptoms Pro-ACT balloons are placed under general anesthesia via a perineal approach laterally to the membranous urethra under the bladder neck This device results in an external compression of the urethra Further adjustment of the compression is possible under local anesthesia since the balloons are linked to a subcutaneous titanium port AdvanceXP male sling is placed under general anesthesia via a perineal approach by transobturator route and results in a suspension of the membranous urethra relocating the bladder neck If multiple reports have claimed for the efficacy of these two devices they have never been compared in a prospective comparative trial Our aims were to compare the efficacy of the two devices and provide data about their cost effectiveness
Hypothesis The study is based on the superiority hypothesis that Advance male slings is more efficacious than Pro-ACT balloons at one year follow-up
Objectives
The primary objective of this study is to compare the efficacy of the Advance retrourethral male sling and periurethral Pro-ACT balloons for post-prostatectomy stress urinary incontinence SUI management
The secondary objectives of this work are
Comprehensive medical evaluation of these two emerging devices in terms of efficiency using the usual criteria in the field of urinary incontinence
Complete evaluation of the side effects of the two techniques
Evaluation of the quality of life
Cost-effectiveness study of the device Total cost over one year of each of the two techniques differential cost-effectiveness ratio cost adjusted by QALY differential cost-effectiveness ratio in terms adjusted to success rate recommendations that can be made for assessing the potential coverage by the French healthcare system
Population The study concerns patients presenting SUI following radical prostatectomy for prostate cancer Patients must be older than 18 without cancer recurrence and must present pure SUI on urodynamics without detrusor overactivity and mild to moderate incontinence 24hour pad-test 300g Every patient showing urethral stricture at preoperative cystoscopy is excluded from the study
Study design This is a prospective randomized multicentric 9 tertiary reference centers comparative trial of the two devices with a superiority hypothesis The study begins with a 12 months inclusion period The total number of subjects required is 240 At the end of the inclusion process a randomization in two arms is carried out Follow-up consists in 4 visits at 1 3 6 and 12 months with data collection pad use uroflowmetry quality of life validated questionnaires ICIQ-SF and EQ-5D 24-hr pad test patient satisfaction with PGI-I and report of any secondary effect Statistical evaluation is carried out at the end of the follow-up in intent to treat
Medical evaluation
The main criterion of the study is failure of the treatment defined by reduction of less than 50 of incontinence on 24-hr pad test explantation of the device or implantation of a new surgical device for SUI management in the year after operation
Secondary criteria are focused on efficacy and tolerance and evaluated during follow-up at 1 3 6 and 12 months on the following criteria
pad usage per day
quantitative reduction of the 24hr-pad test
complications infection erosion hematoma acute urinary retention
number of re-interventions or re-admissions during follow-up
quality of life measured by the ICIQ-SF questionnaire
patient satisfaction by the PGI-I questionnaire The statistical evaluation on the main criterion will be carried out by the chi-square test Variables with a known predictive value on efficiency radiation therapy severity of incontinence will be studied by logistic regression then multivariate analysis The results will be adjusted on the centers multicentric study The quantitative variables will be compared by Mann-Whitney test
Economic evaluation The economic evaluation will be carried out according to the following manner
A study of the total cost over one year of each device based on the data collected during the clinical trial and including all the events that required medical care visits complications reinterventions readmissions but also the cost of pads not supported by healthcare system and only supported by the patient
From this study led on cost and of the collection of quality of life data the cost of each device will be adjusted to quality of life QALY evaluation
A cost effectiveness study will also be lead by adjusting cost to success rate of each technique
Proposals will be made to state at which level the two devices should be covered by the healthcare system
Hypothesis The study is based on the superiority hypothesis that Advance male slings is more efficacious than Pro-ACT balloons at one year follow-up
Objectives
The primary objective of this study is to compare the efficacy of the Advance retrourethral male sling and periurethral Pro-ACT balloons for post-prostatectomy stress urinary incontinence SUI management
The secondary objectives of this work are
Comprehensive medical evaluation of these two emerging devices in terms of efficiency using the usual criteria in the field of urinary incontinence
Complete evaluation of the side effects of the two techniques
Evaluation of the quality of life
Cost-effectiveness study of the device Total cost over one year of each of the two techniques differential cost-effectiveness ratio cost adjusted by QALY differential cost-effectiveness ratio in terms adjusted to success rate recommendations that can be made for assessing the potential coverage by the French healthcare system
Population The study concerns patients presenting SUI following radical prostatectomy for prostate cancer Patients must be older than 18 without cancer recurrence and must present pure SUI on urodynamics without detrusor overactivity and mild to moderate incontinence 24hour pad-test 300g Every patient showing urethral stricture at preoperative cystoscopy is excluded from the study
Study design This is a prospective randomized multicentric 9 tertiary reference centers comparative trial of the two devices with a superiority hypothesis The study begins with a 12 months inclusion period The total number of subjects required is 240 At the end of the inclusion process a randomization in two arms is carried out Follow-up consists in 4 visits at 1 3 6 and 12 months with data collection pad use uroflowmetry quality of life validated questionnaires ICIQ-SF and EQ-5D 24-hr pad test patient satisfaction with PGI-I and report of any secondary effect Statistical evaluation is carried out at the end of the follow-up in intent to treat
Medical evaluation
The main criterion of the study is failure of the treatment defined by reduction of less than 50 of incontinence on 24-hr pad test explantation of the device or implantation of a new surgical device for SUI management in the year after operation
Secondary criteria are focused on efficacy and tolerance and evaluated during follow-up at 1 3 6 and 12 months on the following criteria
pad usage per day
quantitative reduction of the 24hr-pad test
complications infection erosion hematoma acute urinary retention
number of re-interventions or re-admissions during follow-up
quality of life measured by the ICIQ-SF questionnaire
patient satisfaction by the PGI-I questionnaire The statistical evaluation on the main criterion will be carried out by the chi-square test Variables with a known predictive value on efficiency radiation therapy severity of incontinence will be studied by logistic regression then multivariate analysis The results will be adjusted on the centers multicentric study The quantitative variables will be compared by Mann-Whitney test
Economic evaluation The economic evaluation will be carried out according to the following manner
A study of the total cost over one year of each device based on the data collected during the clinical trial and including all the events that required medical care visits complications reinterventions readmissions but also the cost of pads not supported by healthcare system and only supported by the patient
From this study led on cost and of the collection of quality of life data the cost of each device will be adjusted to quality of life QALY evaluation
A cost effectiveness study will also be lead by adjusting cost to success rate of each technique
Proposals will be made to state at which level the two devices should be covered by the healthcare system
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