ABSTRACT

Objectives:

To assess the safety and efficacy of the TFS in patients with prolapse and incontinence, with or without uterine preservation and including the learning curve.

Methods:

The Tissue Fixation System (TFS) is an adjustable minisling which uses small lengths of tape to reinforce loose and damaged ligaments and fascial tissue. This is a twenty four month prospective study in a large outer metropolitan Melbourne hospital. Forty women, mean age 60 (50 - 80) years had site-specific TFS repair for grade II to IV urogenital prolapse. Assessment: pre-operative P.O.P.Q, Urodynamics, QOL Questionnaire. Patients with bowel dysfunction had Wexner Score assessment and defecating proctogram. Patients who were sexually active had PISQ-12 assessment.

Results:

The mean surgical time for placement of each device was 12.3 minutes. Improvement rates at 24 months expressed as %, with 12 months in brackets. Prolapse 80% (90%), USI 90% (85%), dragging lower abdominal pain 90% (90%), anal incontinence 70% (70%), nocturia 50% (50%), overactive bladder symptom 50% (50%). There was an average >80% cure rate of urogynaecological prolapse and stress urinary incontinence. There were no tape erosions, anchor slippage or anchor migrations.

Conclusions:

Contrary to the FDA warning on serious complications with transvaginal mesh15 we found TFS neoligament surgery to be safe and minimally invasive, restoring anatomy and function. The unique design which includes a precise one way tensioning system and use of very small amounts of tape is site specific and effective for all pelvic floor reconstruction. Further evaluation is ongoing.