Synthetic Mesh Materials In Sling Surgery
Information source: Ataturk Training and Research Hospital
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Incontinence
Intervention: Synthetic sling surgery (Procedure)
Phase: N/A
Status: Completed
Sponsored by: Ataturk Training and Research Hospital
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.
Clinical Details
Official title: Use Of Three Types Of Synthetic Mesh Materials In Sling Surgery: A Prospective Randomized Clinical Trial Evaluating Effectiveness And Complications
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment
Primary outcome: continence rates at three years after surgery
Secondary outcome: urethral erosion at three years after surgeryvaginal erosion at three years after surgery Denovo urgency at three years after surgery urine retantion at three years after surgery sutur granuloma at three years after surgery
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.
Eligibility
Minimum age: 31 Years.
Maximum age: 75 Years.
Gender(s): Female.
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
Locations and Contacts
Additional Information
Starting date: July 2004
Last updated: May 4, 2011
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