Value of Urodynamics Prior to Stress Incontinence Surgery 2

Study Overview
=================
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.

Official Title
-----------------
a Multicentered Randomised Controlled Trial to Test the Cost Effectiveness of Urodynamics in Women With Symptoms of Stress Urinary Incontinence in Whom Surgical Treatment is Considered

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: midureteral sling
* Other: surgical therapy or conservative


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptoms of stress urinary incontinence and/or mixed urinary incontinence, predominantly stress incontinence Signs of stress urinary incontinence on physical examination or voiding-diary Patient is a candidate for surgical treatment (as based on history and physical examination) Patient has attended at least 3 months of physiotherapy Patient accepts randomisation Patient is capable to fill out bladder diary's, pad tests and questionnaires Patient understands the Dutch written and spoken language ASA 1 or 2 Exclusion Criteria: Previous incontinence surgery Mixed urinary incontinence, urge component is predominant Prolapse >= 1cm beyond the hymen on Valsalva in supine position Postvoid urinary residual > 150ml Present urinary tract infection The need for additional pelvic surgery (prolapse and/or hysterectomy) Patient is or wants to become pregnant Prior pelvic radiotherapy
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: surgical therapy<br> | Procedure: midureteral sling<br>* midureteral sling<br>|
| Active Comparator: individual management<br> | Other: surgical therapy or conservative<br>* midureteral sling or conservative; medication, physiotherapy<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non inferiority of the improvement of the urinary distress inventory one year after treatment. |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure of incontinence as measured with voiding diary. Complications of surgery for stress urinary incontinence, in particular re-operations and overactive bladder symptoms. Quality of life as measured by RAND-36, Euroqol and IIQ. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stress urinary incontinence, urodynamics, randomized clinical trial, surgery