Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Incontinence
- Sponsor
- Ataturk Training and Research Hospital
- Enrollment
- 144
- Primary Endpoint
- continence rates at three years after surgery
- Status
- Completed
- Last Updated
- 15 years ago
Overview
Brief Summary
The purpose of this study is to determine the clinical results contributions to surgical success,and complications of mixed type of mesh materials as well as prolen mesh materials in sling surgery in a 3 year follow-up the first time in literature.
Detailed Description
Broad based double forced sling operations were performed in 144 patients by using 3 different types of mesh materials between 2004 and 2007. Group I consisted of 48 patients in whom Vypromesh® (Ethicon,USA) was used; Group II consisted of 48 patients in whom Ultrapromesh®( Ethicon,USA) and Group III consisted of 48 patients in whom Prolene light mesh® (Johnson\&Johnson,USA) was used. The data of the patients and the success of the operation were evaluated based on 24hr pad test, ICIQ-SF scoring, and Korman questionnaire analysis. Main outcome measures:The Ultrapromesh® synthetic sling procedures have lower complications incidence and higher success rates than the other synthetic slings in 3-year follow-up.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Stress urinary incontinence
- •Mix urinary incontinence
- •Previous failed anti-incontinence surgery
- •Previous gynecologic surgery
Exclusion Criteria
- •Urodynamical detrusor overactivity or impaired bladder activity
- •Prolaps of pelvic organ
- •Urge incontinence
- •Neurogenic bladder
- •Bladder outlet obstruction
- •Urinary fistula, Pregnancy
- •Active urinary or vaginal enfection
- •Contraindication to anesthesia
- •\> 100ml PVR urine volume
Outcomes
Primary Outcomes
continence rates at three years after surgery
Time Frame: three years after surgery
Ultrapromesh® with its superior biomechanical characteristics and with its high success rates,low vaginal and urethral extrusion and denovo urgency rates determined in clinical studies,can be reliably and effectively used in sling surgery.
Secondary Outcomes
- urethral erosion at three years after surgery(three years after surgery)
- vaginal erosion at three years after surgery(three years after surgery)
- Denovo urgency at three years after surgery(three years after surgery)
- urine retantion at three years after surgery(three years after surgery)
- sutur granuloma at three years after surgery(three years after surgery)