Comparison of short-term outcomes between two sacrospinous suture capture devices : a randomised controlled trial

BACKGROUND Sacrospinous Fixation is a procedure for mid-compartment apical suspension in pelvic organ prolapse surgery with high success rates. The approach by traditional wide dissection has been well-documented. The literature is lacking however with regard to newer devices on the market that use less extensive dissection to perform this procedure. METHODS A randomised controlled trial was carried out comparing the Boston Scientific's Capio Slim® (control) and Bard's Fixt® (intervention) for bilateral sacrospinous fixation in women with mid-compartment prolapse requiring surgery and who met the study criteria. The primary outcome was time (in seconds) to successful bilateral suspension suture placements. Secondary outcomes examined were used to assess short-term safety and efficacy of the devices at the time of the procedure and at the six week follow-up