Randomized clinical trial comparing suprapubic arch sling (SPARC) and tension-free vaginal tape (TVT): one-year results.

PURPOSE: Suprapubic Arch sling (SPARC) has been initially presented as being comparable to Tension-free Vaginal Tape (TVT) without published trials. To test the safety and efficacy of this new product, we designed a prospective, randomized clinical trial with a minimum follow-up of 1 year.

MATERIALS AND METHODS: 84 women presenting with Stress Urinary Incontinence (SUI) were randomly assigned to SPARC or TVT as a minimally invasive mid-urethral sling procedure. All patients were re-evaluated at 1, 6, and 12 months. Symptom assessment, Incontinence Impact Questionnaire (IIQ), physical examination, Uro-Dynamic Studies (UDS) and 1-hour pad test were repeated at 1-year follow-up.

RESULTS: 41 patients were randomized to SPARC and 43 to TVT. The two groups had similar baseline characteristics. Both procedures resulted in similar peri-operative complications: bladder perforation (24% vs. 23%), median estimated blood loss (0-50 ml), median hospital stay (1-night), post-operative analgesia, and persistent urinary retention necessitating tape resection (2 patients in each group). There were three other complications in the SPARC group: tape erosion, infected pelvic hematoma, and urinary tract infection. At 12 months, there was no statistically significant difference between SPARC and TVT, in terms of objective cure rates as determined by 1-hour pad test of less than two grams (83% vs. 95%; p< or =0.1; 12% difference, 95% CI: 25.4% to -1.4%) and subjective cure rates as determined by IIQ scores (49.9+/-25.6 vs. 45.3+/-18.4; p=0.46).

CONCLUSIONS: At 1-year follow-up, there is no statistically significant difference between SPARC and TVT. Longer follow-up is needed to confirm these results.