Prospective, Non-Randomized, Observational Trial of the Surgical Management for Suburethral Slings in Women With Stress Urinary Incontinence
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Stress Urinary Incontinence
- Sponsor
- Cantonal Hospital, Frauenfeld
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cure/improvement rate
- Status
- Completed
- Last Updated
- last month
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.
Investigators
Prof. Dr. Volker Viereck
Prof. Dr.
Cantonal Hospital, Frauenfeld
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.
Outcomes
Primary Outcomes
Cure/improvement rate
Time Frame: 3 months
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).
Secondary Outcomes
- Standing Cough Stress Test(baseline, 3 and 6 months)
- International Consultation on Incontinence Questionnaire(pre-operation, 3 and 6 months)
- King Health Questionnaire(pre-operation, 3 and 6 months)
- Subjective symptom assessment by visual analogue scale(3 and 6 months)
- Post-Operative Pain Assessment(1 day)