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DOI: 10.1055/s-2006-952783
Results of a prospective observational study on efficacy and safety of the TOT-SAFYRE® (TOT/S), a composite silicone-polypropylene sling system for the treatment of stress urinary incontinence (SUI)
Objective: Examine the efficacy and safety of the TOT/S, a composite sling consisting of a macroporous polypropylene mesh and two lateral self-anchoring silicone columns, allowing readjustment but seem to predispose for tape dislocation.
Methods: Between 11/05 and 2/06 79 consecutive operated women with TOT/S between 2003 and 2004 were sent a questionnaire including the validated patient’s global impression of severity and improvement (PGIS/I) (1) and returned averagely after 20.4 months for a gynaecological examination.
Results: 83.3% of all patients (pts) considered their preoperative SUI as 'severe'. Postoperatively 89% of the pts stated that their incontinence had improved 'very much' (47.9%), 'much' (31.5%) or 'a little' (9.6%) while 6.8% showed no change or were worse (4.1%). 59.5% of the pts had subjectively no leakage at any time anymore. 7.6% (53/79) of the sexually active women complained of pain and 1 partner had felt discomfort during sexual intercourse since implantation of the sling. 12.6% of the pts developed de-novo-urgency. Vaginal mesh erosion was found in 8.8%, 3 being entirely asymptomatic. In a further 13.9% of the pts the mesh could be palpated as a rough structure within the vaginal mucosa. In 5 pts the mesh was removed, 2 pts refused further surgery. In 47% of the pts the lateral silicone column which at the time of the initial surgery was covered by lateral muscular tissue could be palpated medial to the pubic bone by two different examiners indicating dislocation.
Conclusions: The TOT/S results in a high subjective continence rate and high subjective patient's satisfaction. The TOT/S erosion rate of 8.8% matches an erosion rate of 6.2% in 129 pts recently published on another TOT procedure (2). Whether the TOT procedure in general or the dislocation of the silicone column found in this study is the major reason remains unclear.