The National Institute for Clinical Excellence is examining bone-anchored cystourethropexy and will publish guidance on its safety and efficacy to the NHS in England and Wales. The Institute's Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisors, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about bone-anchored cystourethropexy.

This document has been prepared for public consultation. It summarises the procedure and sets out the provisional recommendation made by the Advisory Committee.

Note that this document is not the Institute's formal guidance on this procedure. The recommendations are provisional and may change after consultation.

The process that the Institute will follow after the consultation period ends is as follows.

• The Advisory Committee will meet again to consider the original evidence and its provisional recommendation in the light of the comments received during consultation.
• The Advisory Committee will then prepare the Final Interventional Procedures Document (FIPD) and submit it to the Institute.
• The FIPD may be used as the basis for the Institute's guidance on the use of the procedure in the NHS in England and Wales.

For further details, see the Interim Guide to the Interventional Procedures Programme, which is available from the Institute's website (www.nice.org.uk/ip).

Closing date for comments: 24 June 2003
Target date for publication of guidance: 24 September 2003

*SERNIP was the Safety and Efficacy Register of New Interventional Procedures. NICE is reviewing procedures that SERNIP classified.

Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation

Provisional recommendation

Current evidence on the safety and efficacy of bone-anchored cystourethropexy does not appear adequate for this procedure to be used 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, and should ensure that patients offered the procedure understand the uncertainty about its safety and efficacy and that appropriate arrangements are in place for clinical audit. 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. Traditional surgical options in women with severe stress incontinence include hysterectomy, vaginal repair, and laparoscopic or open surgery to lift the uterus (colposuspension). 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 vaginal wall. 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

The studies reviewed showed limited evidence on the efficacy of the cystourethropexy bone-anchoring system compared with other minimally invasive techniques or traditional surgical approaches. In all the case series looking at the In-tac^® cystourethropexy bone-anchoring system, women were followed up for 1 year only. With the Vesica^® cystourethropexy bone-anchoring system four of the studies followed up women for at least 1 year, with the longest follow up being 2 years. Long-term outcomes were therefore uncertain.

The Specialist Advisors considered that the long-term data for this procedure were poor, and that the procedure confers no benefit over other procedures.

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 different approaches may be associated with different complication rates.

The Specialist Advisors reported that osteomyelitis is a particular complication.

Other comments

The Interventional Procedures Advisory Committee's decision was made on data from the use of only two devices (Vesica® and In-tac®).