Infracoccygeal sacropexy using mesh for vaginal vault prolapse repair: interventional procedure consultation document
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE
Interventional Procedure Consultation Document
Infracoccygeal sacropexy using mesh for vaginal vault prolapse repair
| Vaginal vault prolapse occurs in women who have had their wombs removed surgically, when the upper vaginal wall (called the vaginal vault) slips down from its normal position. Infracoccygeal sacropexy is an operation involving the insertion of a piece of material (mesh) with the aim of holding the vaginal vault in place |
|
The National Institute for Health and Clinical Excellence (NICE) is examining infracoccygeal sacropexy using mesh for vaginal vault prolapse repair and will publish guidance on its safety and efficacy to the NHS in England, Wales, Scotland and Northern Ireland. NICE?s Interventional Procedures Advisory Committee has considered the available evidence and the views of Specialist Advisers, who are consultants with knowledge of the procedure. The Advisory Committee has made provisional recommendations about infracoccygeal sacropexy using mesh for vaginal vault prolapse repair. This document summarises the procedure and sets out the provisional recommendations made by the Advisory Committee. It has been prepared for public consultation. The Advisory Committee particularly welcomes:
Note that this document is not NICE's formal guidance on this procedure. The recommendations are provisional and may change after consultation. The process that NICE will follow after the consultation period ends is as follows.
For further details, see the Interventional Procedures Programme manual, which is available from our website (www.nice.org.uk/ipprogrammemanual). NICE is committed to promoting through its guidance race and disability equality and equality between men and women, and to eliminating all forms of discrimination. One of the ways we do this is by trying to involve as wide a range of people and interest groups as possible in the development of our guidance on interventional procedures. In particular, we aim to encourage people and organisations from groups in the population who might not normally comment on our guidance to do so. We also ask consultees to highlight any ways in which draft guidance fails to promote equality or tackle discrimination and give suggestions for how it might be improved. Closing date for comments: 24 September 2008 Target date for publication of guidance: December 2008 |
| Note that this document is not the Institute's guidance on this procedure. The recommendations are provisional and may change after consultation. |
| 1 | Provisional recommendations | |
| 1.1 | Current evidence on the efficacy and safety of infracoccygeal sacropexy using mesh for vaginal vault prolapse repair is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. | |
| 1.2 |
Clinicians wishing to undertake infracoccygeal sacropexy using mesh for vaginal vault prolapse repair should take the following actions:
|
|
| 1.3 | The procedure should only be carried out by surgeons specialising in the management of pelvic organ prolapse and female urinary incontinence. | |
| 1.4 | The British Society for Urogynaecology runs a database on urogynaecological procedures, and clinicians should enter details about all patients undergoing this procedure onto this database (www.bsug.net). | |
| 1.5 | NICE encourages the entry of women having this procedure into well-designed studies, and may review the procedure on publication of further evidence. Clinicians are encouraged to collect long-term data on clinical outcomes and patient-reported quality-of-life outcomes using validated scales. | |
| 2 | The procedure | |
| 2.1 | Indications and current treatments | |
| 2.1.1 | Vaginal vault prolapse can occur in women who have had a hysterectomy. The uppermost part of the vagina descends from its normal position, sometimes out through the vaginal opening. It can affect quality of life by causing symptoms of pressure and discomfort, and by its effect on urinary, bowel and sexual function. | |
| 2.1.2 | Current treatment options include pelvic floor muscle training, use of pessaries and surgery. Some surgical procedures involve the use of mesh, with the aim of providing additional support. | |
| 2.2 | Outline of the procedure | |
| 2.2.1 | The procedure is performed with the patient under general anaesthesia. An incision is made in the posterior wall of the vagina and puncture incisions in each buttock. A tape (mesh) is introduced through one buttock and a tunnelling device (guided by a finger through the vaginal incision) is used to pass it around the rectum. It is then passed up the side of the vagina, across the top, and then out through the incision in the other buttock. The tape is sutured to the top of the vagina to act as a tension-free sling to suspend the vaginal vault. | |
| 2.2.2 | This procedure can be combined with a hysterectomy or surgery for stress urinary incontinence. | |
| 2.2.3 | A number of different types of synthetic and biological mesh are available, which vary in structure and in their physical properties such as absorbability. | |
|
||
| 2.3 | Efficacy | |
| 2.3.1 | A case series of 93 women treated by infracoccygeal sacropexy reported subjective failure in 9% (8/91) of women (mean follow-up 12 months, two women lost to follow-up). | |
| 2.3.2 | A case series of 75 women reported objective failure within 24 months in 10% (4/40) of women (35 patients lost to follow-up). A case series of 20 women reported no objective failure (0/20) at a mean follow-up of 16 months. | |
| 2.3.3 | Case series of 93 and 75 women reported that 2% (2/91) and 30% (12/40) of women, respectively, had further surgery for vault prolapse at a mean follow-up of 12 months, between 1 and 4.5 years, and at a mean of 16 months, respectively. | |
| 2.3.4 | The Specialist Advisers considered key efficacy outcomes to include success rates, as measured by the pelvic organ prolapse quantification system (POPQ), and outcomes including resolution of prolapse symptoms and urinary, bowel and sexual function. Three Advisers noted a need for long-term efficacy outcomes. | |
| 2.4 | Safety | |
| 2.4.1 | Rectal perforation was reported in 1% (1/93) and 3% (2/75) of patients in the case series of 93 and 75 women, respectively (subsequent management and follow-up not stated). | |
| 2.4.2 | Mesh erosion was reported in 7% (2/30) of women treated by infracoccygeal sacropexy in a randomised controlled trial of 60 women (conference abstract only) at a mean follow-up of 24 months. Four case series of 93, 75, 52 and 15 women reported mesh erosion in 6% (6/93), 5% (4/75), 21% (11/52) and 7% (1/15) of women at mean follow-up periods of between 20 weeks and 12 months. | |
| 2.4.3 | Infection was reported in 5% (5/93) and 1% (1/75) of women (urinary tract infection and unspecified infection, respectively) within one week of surgery in the case series of 93 and 75 patients, respectively. | |
| 2.4.4 | The Specialist Advisers considered theoretical adverse events to include functional disturbance of the bowel or bladder, rectal injury, infection/sepsis, mesh erosion or rejection, and dyspareunia. One Adviser commented that the development of new types of mesh means that current mesh-related complication rates may be lower than those available in the evidence. | |
| 3 | Further information | |
| 3.1 | This guidance requires that clinicians undertaking the procedure make special arrangements for audit. NICE has identified relevant audit criteria and is developing audit support (which is for use at local discretion), which will be available when the guidance is published. | |
| 3.2 | NICE has published guidance on surgical repair of vaginal wall prolapse using mesh and is developing guidance on infracoccygeal sacropexy using mesh for uterine prolapse repair, sacrocolpopexy using mesh for uterine and vaginal vault prolapse repair and the insertion of a mesh uterine suspension sling (including sacrohysteropexy) for uterine prolapse repair. For more information go to www.nice.org.uk. | |
Bruce Campbell
Chairman, Interventional Procedures Advisory Committee
DATE 2008
This page was last updated: 30 March 2010
