Surgical Management for Suburethral Slings

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized, observational, single center study in which subjects that have surgically-correctable Stress Urinary Incontinence undergo a suburethral sling operative procedure.

Detailed Description
-----------------
The study will collect preoperative urologic testing, medical history, and subject quality of life patient questionnaires. Intraoperative procedural data will be collected. Postoperative complications, urologic, testing, and subject questionnaires will be collected at intervals. The anatomic position of the device will be characterize by introital ultrasound testing.

Official Title
-----------------
Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has objective demonstrable signs of stress urinary incontinence (SUI), including patients with intrinsic sphincter deficiency (ISD). Objective testing includes: standing stress test, urodynamics evaluation, or pad test. Patient is age 18 or older. Patient agrees to participate in the study, including completion of all study-related procedures and evaluations, and documents this agreement by signing the IRB/EC-approved informed consent. Patient is able to fill in all questionnaires (on judgement of investigator) Exclusion Criteria: Patient has an associated or suspected neurological disease. Patient has an active lesion or present injury to perineum or urethra. Patient has a urethral obstruction. Patient has significant pelvic organ prolapse (Grade III/IV) requiring surgical treatment. The subject has current urinary tract infection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stress Urinary Incontinence<br>Females with stress urinary incontinence, who undergo a tension free surgical sling procedure. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cure/improvement rate | Patients are classified as cured if the postoperative cough test (see Outcome 4 below) is negative and the degree of subjective suffering (see Outcome 2 below) improves to over 90% (VAS score of 0 or 1). Criteria for improvement are involuntary loss of only a few drops of urine during straining and an improvement of the degree of suffering to over 75% (VAS score of 2 or 3). All other patients are classified as therapeutic failures (even if they show marked improvement of one of the parameters compared with their preoperative status). | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective symptom assessment by visual analogue scale | Scale: 0-10 (0-no suffering, 10-severe suffering) | 3 and 6 months | 
| Post-Operative Pain Assessment | Scale: 0-10 (0-no pain, 10-severe pain) | 1 day | 
| Standing Cough Stress Test | 3 categories: negative/severe, if flow of urine is observed. negative/mild, if the loss of only a few drops is observed. positive, if no urine loss occurs. | baseline, 3 and 6 months | 
| King Health Questionnaire |  | pre-operation, 3 and 6 months | 
| International Consultation on Incontinence Questionnaire |  | pre-operation, 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress Urinary Incontinence, Suburethral Sling