Transvaginal cystourethropexy using bone anchors system for treatment of stress urinary incontinence

Objective: A new minimally invasive surgical procedure using a staple-like bone anchor inserter was developed for the treatment of women with stress incontinence. We assessed the safety and efficacy of this bone anchor device and surgical technique. Materials: 47 consecutive female pts ages 38 to 81 years (mean 53 years) were treated for type I or II stress incontinence. Initial evaluation included: history, questionnaire, physical exam, urine culture, pad test (or count) CMG and measurement of post void residual urine (PVR). All but CMG were repeated periodically after surgery. General, spinal or local anesthesia was used. With the patients in the lithotomy position the bone anchor inserter is introduced into the vagina and pulled towards the posterior surface of the pubic bone. Pressing a button drives a sharp 9X2.4mm bone anchor made of a shape memory Alloy attached to a # 1 prolene suture through the cortex of the pubis. Once inside the bone and heated to body temperature the anchor curves so as to fixate itself in the cortex. Two anchors are positioned on each side of the urethra : Each ipsilateral pairs of sutures are tied together resulting in fixation of the periurethral tissue to the pubis. Results: The procedure was successfully performed in all pts without intraoperative bleeding. No clinical or radiological evidence of osteitis pubis were noted. Concomitant pelvic surgery was performed in 28 (60%) cases. With median follow-up of 9 months (range 2-18 months)38 (81%) are completely dry, 7 (15%) reported symptomatic improvement (requiring 1-2 pads/day), 2 pts (4%) failed. Permanent retention did not occur. A average PVR is 20ml. Two (4%) pts developed UTI and 3 (6%) had transient dyspareuma. Bone pain or tenderness were not recorded. Conclusions: Our data suggests that this new minimally invasive procedure is easy to learn, quick, safe and effective. A longer follow-up is required to assess its durability.