Ignite Creation Date:
2024-05-05 @ 6:33 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00509730
Status:
TERMINATED
Last Update Posted:
2009-10-07
First Post:
2007-07-30
Brief Title:
Value of Urodynamics Prior to Stress Incontinence Surgery
Sponsor:
Radboud University Medical Center
Organization:
Radboud University Medical Center
Study Overview
Official Title:
Multicentered Randomized Controlled Trail to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered
Status:
TERMINATED
Status Verified Date:
2008-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VUSIS
Brief Summary:
To test the value of preoperatively performed urodynamics with regard to outcome of surgery for stress urinary incontinence SUI and to examine whether not performing urodynamics preoperatively is more cost effective than performing urodynamics preoperatively using the non-inferiority assumption
Detailed Description:
Design multidisciplinary and multicentre randomized controlled trial
Study populationinclusion criteria all women not previously operated for stress incontinence seeking help for urinary stress incontinence where conservative therapy in particular physiotherapy has failed and are opting and candidates for surgical therapy will be asked to participate in our study Incontinence must have been demonstrated on physical examination andor micturition diary Patients can be included by gynaecologists or urologists who are cooperating in the study
Intervention consists of the non performance of urodynamics in the studygroup The control group will undergo urodynamics as is at present the norm
In all patients the next items will be recorded at inclusion
1 History and clinical examination
2 48h-Bladdervoiding and incontinence diary
3 48h-Pad test
4 Validated Quality of Life questionnaires SF 36 Euroqol 5D UDI IIQ
5 Urinalysis for the detection of urinary tract infection
6 Residual urine measured by ultrasound
At this point an interim decision will be made for surgery At that moment patients are informed about the study After obtaining informed consent the patients are randomly assigned to undergo urodynamic testing or not In the study group the decision for intervention will be based on the history and clinical examination only and will be the same as the interim decision which is surgery
In the control group this decision will be based on history and clinical examination IN COMBINATION with the result of the urodynamic testing It can be a decision to proceed with surgery estimated at 23rd of the women or conservative usually medication The T0moment of intervention is defined as the moment of the first intervention which is by definition surgery in the study group and either surgery or conservative in the control group After the intervention additional therapy is possible in both arms
The follow-up period will be 24 months after T0 in which the same parameters as pre-operative will be assessed
These items will be assessed at
6 weeks post intervention PI 3 months PI 6 months PI 12 months PI 24 months PI
Urodynamics in the control group will be performed according to ICS standards and consist of free flow fillingscystometry pressure flow study and a urethral pressure profilometry in rest and during stress The outcomes will be matched to urodynamic findings to indicate the possible useful parts of the urodynamic findings
Post operative urodynamics is NOT part of the study
The primary outcome of this study is the improvement of Urogenital Distress Inventory UDI at 24 months after baseline and the power calculation is performed using the non-inferiority assumption The mean improvement in UDI in both groups is expected to be 35 with standard deviation 1022 A difference in mean improvement of 8 or less is considered non-inferior As this condition is allowed for one third of the total group those women in the non-UDI group who would not have been operatively treated this results in a difference in mean improvement of 27 or less between the UDI and non-UDI group Then effectively 130 women in each group are needed to reach a power of 70 using one-sided testing at 005 Considering an expected percentage lost to follow up of ca 10 in total 290 women 145 in each group will be included in this study
Multivariate analysis of covariance with group centre and the baseline covariate as independent variables will be used to estimate differences in improvement of the UDI after 24 months between the groups with 95 confidence intervals As the UDI is skewed data will be logtransformed prior to analysis Other variables ie Incontinence Impact Questionnaire will be analysed similar
Economic evaluation
For each patient utilisation of health care services will be recorded prospectively using Case Record Forms including urodynamic testing surgery for SUI re-operations medical treatment for detrusor instability care for urinary incontinence and care for urinary retention By multiplying these volumes of care with unit cost prices direct medical costs incurred by SUI during the follow up period will be calculated for each patient For unit cost prices national guidelines will be used CVZ 2004 For costs of care for urinary incontinence and urinary retention data from the literature will be used converted to 2006 prices We incorporated the health related quality of life questionnaire euroqol 5D in our study to be able to calculate QALYs quality-adjusted life-years which is a measure of health outcomes A QALY is the change in quality of life induced by the treatment multiplied by the duration of the treatment effect and it provides the number of QALYs gained QALYs can then be related to medical costs to arrive at a final common denominator of costQALY This parameter can be used to compare the cost-effectiveness of the treatment
Study populationinclusion criteria all women not previously operated for stress incontinence seeking help for urinary stress incontinence where conservative therapy in particular physiotherapy has failed and are opting and candidates for surgical therapy will be asked to participate in our study Incontinence must have been demonstrated on physical examination andor micturition diary Patients can be included by gynaecologists or urologists who are cooperating in the study
Intervention consists of the non performance of urodynamics in the studygroup The control group will undergo urodynamics as is at present the norm
In all patients the next items will be recorded at inclusion
1 History and clinical examination
2 48h-Bladdervoiding and incontinence diary
3 48h-Pad test
4 Validated Quality of Life questionnaires SF 36 Euroqol 5D UDI IIQ
5 Urinalysis for the detection of urinary tract infection
6 Residual urine measured by ultrasound
At this point an interim decision will be made for surgery At that moment patients are informed about the study After obtaining informed consent the patients are randomly assigned to undergo urodynamic testing or not In the study group the decision for intervention will be based on the history and clinical examination only and will be the same as the interim decision which is surgery
In the control group this decision will be based on history and clinical examination IN COMBINATION with the result of the urodynamic testing It can be a decision to proceed with surgery estimated at 23rd of the women or conservative usually medication The T0moment of intervention is defined as the moment of the first intervention which is by definition surgery in the study group and either surgery or conservative in the control group After the intervention additional therapy is possible in both arms
The follow-up period will be 24 months after T0 in which the same parameters as pre-operative will be assessed
These items will be assessed at
6 weeks post intervention PI 3 months PI 6 months PI 12 months PI 24 months PI
Urodynamics in the control group will be performed according to ICS standards and consist of free flow fillingscystometry pressure flow study and a urethral pressure profilometry in rest and during stress The outcomes will be matched to urodynamic findings to indicate the possible useful parts of the urodynamic findings
Post operative urodynamics is NOT part of the study
The primary outcome of this study is the improvement of Urogenital Distress Inventory UDI at 24 months after baseline and the power calculation is performed using the non-inferiority assumption The mean improvement in UDI in both groups is expected to be 35 with standard deviation 1022 A difference in mean improvement of 8 or less is considered non-inferior As this condition is allowed for one third of the total group those women in the non-UDI group who would not have been operatively treated this results in a difference in mean improvement of 27 or less between the UDI and non-UDI group Then effectively 130 women in each group are needed to reach a power of 70 using one-sided testing at 005 Considering an expected percentage lost to follow up of ca 10 in total 290 women 145 in each group will be included in this study
Multivariate analysis of covariance with group centre and the baseline covariate as independent variables will be used to estimate differences in improvement of the UDI after 24 months between the groups with 95 confidence intervals As the UDI is skewed data will be logtransformed prior to analysis Other variables ie Incontinence Impact Questionnaire will be analysed similar
Economic evaluation
For each patient utilisation of health care services will be recorded prospectively using Case Record Forms including urodynamic testing surgery for SUI re-operations medical treatment for detrusor instability care for urinary incontinence and care for urinary retention By multiplying these volumes of care with unit cost prices direct medical costs incurred by SUI during the follow up period will be calculated for each patient For unit cost prices national guidelines will be used CVZ 2004 For costs of care for urinary incontinence and urinary retention data from the literature will be used converted to 2006 prices We incorporated the health related quality of life questionnaire euroqol 5D in our study to be able to calculate QALYs quality-adjusted life-years which is a measure of health outcomes A QALY is the change in quality of life induced by the treatment multiplied by the duration of the treatment effect and it provides the number of QALYs gained QALYs can then be related to medical costs to arrive at a final common denominator of costQALY This parameter can be used to compare the cost-effectiveness of the treatment
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 80-007022-98-07203 | None | None | None |