Synthetic Mesh Materials In Sling Surgery

Not Applicable

Completed

• Conditions: Incontinence

• Registration Number: NCT01348334
• Lead Sponsor: Ataturk Training and Research Hospital

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.

Study Timeline

• Status Verified: 2004-07
• Study Start: 2004-07
• Primary Completion: 2007-07
• Study Completion: 2010-11
• Study First Submitted: 2011-04-28
• Study First Submitted QC: 2011-05-04
• Last Update Submitted: 2011-05-04
• Study First Posted: 2011-05-05
• Last Update Posted: 2011-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
continence rates at three years after surgery	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 Outcome Measures

Name	Time	Method
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