Assessment of a new bone anchor system for the treatment of female genuine stress incontinence.

Abstract

To evaluate the efficacy of the In-Tac bone-anchor system (using shape-memory metal bone anchors, Influence Medical Technologies, Lancs, UK) as a vaginal procedure for the treatment of female genuine stress incontinence (GSI). Between January 1997 and April 1998, 30 patients with GSI were recruited into the study (age range 36-74 years); patients who had undergone previous failed continence surgery were not excluded. All patients underwent a urodynamic assessment before and 3 months after surgery. All In-Tac bone-anchor procedures were performed under general anaesthesia. Patients were reviewed after surgery at 6 weeks, 3, 6 and 12 months, and yearly thereafter. The mean (range) operative duration was 42 (20-75) min and the blood loss 60 (10-200) mL (median 30). There were no intraoperative complications and minimal analgesia was required postoperatively. At 6 weeks, 27 patients (90%) were subjectively cured. The urodynamic assessment at 3 months revealed that 22 patients (73%) were objectively cured; at 6 months and one year the subjective cure rate was 80%. The In-Tac bone-anchor system is simple and safe, the procedure easily learned and the operation brief. It offers promise as an incision-less vaginal procedure that may have wide application for the treatment of women with GSI. A longer follow-up is needed to fully confirm its durability and effectiveness.