Bone-anchored cystourethropexy

Evidence-based recommendations on bone-anchored cystourethropexy for treating stress urinary incontinence in women. Bone-anchored cystourethropexy is a minimally invasive bladder neck needle suspension procedure.

# Guidance
Current evidence of the safety and efficacy of bone-anchored cystourethropexy does not appear adequate to support the use of this procedure without special arrangements for consent and for audit or research. Clinicians wishing to undertake bone-anchored cystourethropexy should inform the clinical governance leads in their Trusts. They should ensure that patients offered it understand the uncertainty about the procedure's safety and efficacy and should provide them with clear written information. In particular patients should be informed that the long-term efficacy of the procedure appears to be poor. Use of NICE's information for the public is recommended. Clinicians should ensure that appropriate arrangements are in place for audit or research. Publication of safety and efficacy outcomes will be useful in reducing the current uncertainty. NICE is not undertaking further investigation at present.# The procedure

# Indications
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.
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.

# Outline of the procedure
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.

# Efficacy
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'.
The Specialist Advisors considered that the long-term data for this procedure were poor.

# Safety
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'.
The Specialist Advisors reported that osteomyelitis is a potentially important complication.

# Other comments
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.# Further information

# Sources of evidence
The evidence considered by the Interventional Procedures Advisory Committee is described in the following documents.
Interventional procedure overview of bone-anchored cystourethropexy (In-tac)
Interventional procedure overview of bone-anchored cystourethropexy (Vesica)

# Information for patients
NICE has produced information on this procedure for patients and carers. It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.