2 The procedure
2.1.1 Uterine prolapse is the protrusion of the uterus down into, and sometimes through, the vagina. 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. Several surgical procedures can be used, including hysterectomy, infracoccygeal sacropexy, uterine suspension sling (including sacrohysteropexy) and uterine/vault suspension (without sling). Some of these procedures involve the use of mesh, with the aim of providing additional support.
2.2.1 Sacrocolpopexy with hysterectomy using mesh for uterine prolapse is performed with the patient under general anaesthesia. An open or laparoscopic approach is used, following on from a concomitant hysterectomy. Mesh is attached to the apex of the vagina and may also be attached to the anterior and/or posterior vaginal wall, with the aim of preventing future vaginal vault prolapse.
2.2.2 This procedure can be combined with surgery for stress urinary incontinence such as colposuspension or suburethral sling placement.
2.2.3 Several different types of synthetic and biological mesh are available, which vary in structure and in their physical properties such as absorbability.
Sections 2.3 and 2.4 describe efficacy and safety outcomes which were available in the published literature and which the Committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the overview.
2.3.1 A non-randomised study that compared 36 women treated by mesh sacrohysteropexy with 39 women treated by hysterectomy followed by sacrocolpopexy reported no objective failure (defined as prolapse at less than 6 cm above the hymen) in either group (0/36 and 0/39) at a mean follow-up of 51 months.
2.3.2 The same study reported that none of the 75 women required a further operation for recurrent or de novo prolapse at a mean follow-up of 51 months.
2.3.3 The Specialist Advisers considered key efficacy outcomes to include improvement in symptoms and sexual function. One Specialist Adviser also considered long-term success of more than 5 years to be an important outcome.
2.4.1 Mesh erosion was reported in 4% (1/23) of women treated by hysterectomy followed by sacrocolpopexy in a randomised controlled trial (RCT) of 47 women (available as a conference abstract; mean follow-up 33 months). The non-randomised comparative study of 75 women reported no mesh erosion (0/36) in the sacrohysteropexy group and mesh erosion in 8% (3/39) of women in the hysterectomy and sacrocolpopexy group (mean follow-up 51 months); all women with mesh erosion required further surgery. Another non-randomised comparative study of 104 women reported erosion rates of 11% (8/76) in women having total hysterectomy followed by sacrocolpopexy and 4% (1/28) in women having supracervical hysterectomy followed by sacrocolpopexy (median follow-up 4 months); 4 of the 8 women in the first group required further surgery for mesh erosion. A case series of 324 women reported that 7% (7/101) of women had mesh erosion after hysterectomy followed by sacrocolpopexy at a median follow-up of 8.4 months (range 1.4–13 months).
2.4.2 Wound infection was reported in 8% (3/39) of women treated by hysterectomy and sacrocolpopexy in the non-randomised comparative study of 75 women.
2.4.3 Perivesical haematoma or voiding dysfunction were reported in 17% (6/36) of women treated by sacrohysteropexy and 13% (5/39) of women who had hysterectomy followed by sacrocolpopexy in the non-randomised comparative study of 75 women (time of occurrence not reported).
2.4.4 The Specialist Advisers considered theoretical adverse events to include osteomyelitis, bleeding from local major vessels, bladder or bowel perforation, urinary incontinence, bowel obstruction, mesh infection or rejection, and dyspareunia. One Specialist 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.