Synthetic Mesh Materials In Sling Surgery

Ataturk Training and Research Hospital

Status: Completed

Conditions: Incontinence

Treatments: Procedure: Synthetic sling surgery

Study type: Interventional

Funder types: Other

Identifiers

NCT01348334

Ataturk TRH-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 31 to 75 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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144 participants in 3 patient groups

Vypromesh®(Ethicon,USA)

Active Comparator group

Description:

Vypromesh®(semiabsorbable multiflament mesh;non-absorbable Polypropylene+absorbable Poliglactin)

Treatment:

Procedure: Synthetic sling surgery

Ultrapromesh®(Ethicon,USA)

Active Comparator group

Description:

Ultrapromesh®(semiabsorbable monofilament mesh;non-absorbable Polypropylene+absorbable polyglecaprone).

Treatment:

Procedure: Synthetic sling surgery

Prolene light mesh®(Johnson&Johnson,USA)

Active Comparator group

Description:

Prolene light mesh®(cpp-Condensed monofilament non absorbable polypropylene mesh)

Treatment:

Procedure: Synthetic sling surgery