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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


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 surgery

vaginal 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.


Minimum age: 31 Years. Maximum age: 75 Years. Gender(s): Female.


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

Page last updated: August 23, 2015

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