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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Blasenzentrum, Cantonal Hospital
Frauenfeld, Thurgau, Switzerland
RECRUITINGCure/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).
Time frame: 3 months
Subjective symptom assessment by visual analogue scale
Scale: 0-10 (0-no suffering, 10-severe suffering)
Time frame: 3 and 6 months
Post-Operative Pain Assessment
Scale: 0-10 (0-no pain, 10-severe pain)
Time frame: 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.
Time frame: baseline, 3 and 6 months
King Health Questionnaire
Time frame: pre-operation, 3 and 6 months
International Consultation on Incontinence Questionnaire
Time frame: pre-operation, 3 and 6 months
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