2 The procedure
2.1.1 Bone-anchored cystourethropexy is used to treat stress incontinence in women. Stress incontinence refers to urine leakage that occurs when the pressure within the abdomen is raised during, for example, lifting, coughing or laughing. It is often a result of damage to the pelvic muscles during childbirth, which leads to the bladder 'dropping', so that the normal muscular mechanism that prevents the flow of urine into the urethra is disturbed.
2.1.2 Stress urinary incontinence is a common problem. Most women with stress incontinence are treated without surgery. Surgical options in women with stress incontinence include colposuspension and sling procedures. During 2000/01, about 10,000 operations on the outlet of the female bladder were carried out in England. These were largely performed through open abdominal operations or transvaginally.
2.2.1 Bone-anchored cystourethropexy is a minimally invasive bladder-neck needle-suspension procedure. Bone anchors are screwed into the pubic bone through the vagina or by a small abdominal incision. Sutures are passed into the vaginal wall on either side of the bladder neck and pulled upwards to elevate the vaginal wall and the bladder neck. These sutures are then tied to the bone anchors.
2.3.1 In three studies of the In-tac® cystourethropexy bone-anchoring system, 1-year continence rates were between 80% (24/30) and 82% (50/61). In a more recent case series of 28 women with a mean follow-up of 67.7 months, only six (21.4%) women remained continent at final follow-up. Four studies of the Vesica® cystourethropexy bone-anchoring system have followed up women for at least 1 year, with one study reporting on 5-year outcomes. This study reported that 95% (39/41) of women were continent at 6 months but only 15% (6/41) remained continent at 5 years. For more details refer to 'Sources of evidence'.
2.3.2 The Specialist Advisors considered that the long-term data for this procedure were poor.
2.4.1 The studies reported a number of complications including bone and urinary tract infection, urinary retention and dyspareunia. However, the incidence of these complications was low. The procedure may be undertaken percutaneously or transvaginally and these approaches may be associated with different complication rates. For more details refer to 'Sources of evidence'.
2.4.2 The Specialist Advisors reported that osteomyelitis is a potentially important complication.
2.5.1 Evidence was presented to the Interventional Procedures Advisory Committee on the use of two devices for this procedure (In-tac‚ and Vesica‚) as specified in the Safety and Efficacy Register of New Interventional Procedures (SERNIP). The Committee's decision was made on the basis of data from the use of these two devices.