Sacrocolpopexy with hysterectomy using mesh to repair uterine prolapse

Evidence-based recommendations on sacrocolpopexy with hysterectomy using mesh to repair uterine prolapse. This involves attaching mesh from the top of the vagina to the base of the spine to support the pelvic organs after the womb has been removed.

# Recommendations
Current evidence on the safety and efficacy of sacrocolpopexy with hysterectomy using mesh to repair uterine prolapse is inadequate in quantity and quality. Therefore this procedure should only be used with special arrangements for clinical governance, consent and audit or research. Find out what special arrangements mean on the NICE interventional procedures guidance page.
Clinicians wishing to do sacrocolpopexy with hysterectomy using mesh to repair uterine prolapse should:
Inform the clinical governance leads in their trusts.
During the consent process, ensure that patients understand the uncertainty about the procedure's safety, including mesh erosion (for example, into the vagina) and the risk of recurrence, and provide them with clear written information. In addition, the use of NICE's information for the public is recommended.
Patient selection and treatment should only be done by specialists with experience in managing pelvic organ prolapse and urinary incontinence in women. All clinicians doing this procedure should have specific up-to-date training in the procedure.
Clinicians should enter details about all patients having sacrocolpopexy with hysterectomy using mesh to repair uterine prolapse onto an appropriate registry (for example, the British Society of Urogynaecology database). All adverse events involving the medical device used in this procedure should be reported to the Medicines and Healthcare products Regulatory Agency.
NICE may update the guidance on publication of further evidence.# Indications and current treatments
Uterine prolapse is when the uterus descends from its usual position, into and sometimes through, the vagina. It can affect quality of life by causing pressure and discomfort, and by its effect on urinary, bowel and sexual function.
Current treatment options include pelvic floor muscle training, use of pessaries and surgery. Different surgical procedures can be used, including hysterectomy, infracoccygeal sacropexy, uterine suspension sling (including sacrohysteropexy) and uterine or vault suspension (without sling). Some of these procedures involve the use of mesh, to provide additional support.# The procedure
Sacrocolpopexy with hysterectomy using mesh to repair uterine prolapse is done with the patient under general anaesthesia. An open or laparoscopic abdominal approach is used after the hysterectomy. Mesh is attached to the apex of the vagina and may also be attached to the anterior or posterior vaginal wall, to prevent future vaginal vault prolapse.
This procedure can be combined with surgery for stress urinary incontinence such as colposuspension or suburethral sling placement. Several different types of synthetic and biological mesh are available, which vary in structure and in their physical properties, such as absorbability.# Efficacy
This section describes efficacy outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedures overview.
A non-randomised study, included in a systematic review of 311 women with uterine prolapse, compared 36 women treated by mesh sacrohysteropexy with 39 women treated by hysterectomy with concomitant sacrocolpopexy. There was no objective failure (defined as prolapse at less than 6 cm above the hymen) in either group. This was at a mean followup of 51 months.
In the same non-randomised study included in the systematic review of 311 women, none of the 75 women needed a further operation for recurrent or de novo prolapse at a mean followup of 51 months. In a prospective case series of 67 women treated by sacrocolpopexy with concomitant total abdominal hysterectomy, recurrent stage 2 rectocele without any cystoceles or vault prolapse occurred in 8% (4/64) of women at a median followup of 27 months. A retrospective comparative study of 182 women with uterovaginal prolapse compared 123 women treated by total vaginal hysterectomy with concomitant laparoscopic sacrocolpopexy (TVH+LSC) with 59 women treated by laparoscopic supracervical hysterectomy with concomitant laparoscopic sacrocolpopexy (LSCH+LSC). There was no difference in anatomical success (defined as no prolapse at or beyond the hymen and no apical prolapse beyond the mid-vagina; TVH+LSC 94% versus LSCH+LSC 93%, p=0.8) or subjective success (defined as the absence of bulge symptoms and overall Patient Global Impression of ImprovementI response of 'very much better' or 'much better'; TVH+LSC 91% versus LSCH+LSC 81%, p=0.3) between the 2 groups.
In the prospective case series of 67 women treated by sacrocolpopexy with concomitant total abdominal hysterectomy, 93% (60/64) of women reported satisfaction with the procedure at a median followup of 27 months. Mean pelvic floor distress inventory scores improved from 50 to 10 (p=0.001).
The specialist advisers considered key efficacy outcomes as patient satisfaction, correction of prolapse and reduction of a bulge.
Six commentaries from patients who had experience of this procedure were received, which were discussed by the committee.# Safety
This section describes safety outcomes from the published literature that the committee considered as part of the evidence about this procedure. For more detailed information on the evidence, see the interventional procedures overview.

# Mesh erosion

## Abdominal sacrocolpopexy with concomitant hysterectomy
The risk of mesh erosion varied across 4 studies on abdominal sacrocolpopexy with concomitant hysterectomy to repair uterine prolapse included in a systematic review.
Mesh erosion was reported in 4% (1/23) of women treated by hysterectomy with concomitant sacrocolpopexy in a randomised controlled trial of 47 women available as a conference abstract (mean followup 33 months).
In a non-randomised comparative study of 75 women, mesh erosion occurred in 8% (3/39) of women treated by hysterectomy with concomitant sacrocolpopexy and in no women (0/36) in the sacrohysteropexy group (mean followup 51 months); all women with mesh erosion needed further surgery.
In another non-randomised comparative study of 88 women, erosion rates of 11% (8/76) were reported in women treated by total hysterectomy with concomitant sacrocolpopexy and in 4% (1/28) of women treated by supracervical hysterectomy with concomitant sacrocolpopexy (median followup 4 months); 4 of the 8 women with mesh erosion needed further surgery.
In a case series of 324 women, 7% (7/101) of women reported mesh erosion after hysterectomy with concomitant sacrocolpopexy at a median followup of 8.4 months (range 1.4 to 13 months).
In a retrospective non-randomised comparative study of 179 women, mesh erosion was reported in 6.5% (5/74) of women in the hysterectomy with concomitant sacrocolpopexy group, in 5.9% (3/51) of women in the sacrohysteropexy group and in 7.4% (4/54) of women in the sacrocolpopexy group with previous hysterectomy at a mean followup 57 months. The time to mesh erosion ranged from 2 to 66 months. Four erosions were asymptomatic and 5 presented with vaginal bleeding, associated with dyspareunia in 2 women and infection in 3 women. In all women, surgery was needed to remove the mesh because conservative management did not work.
In a case-control study of 336 women treated by abdominal sacrocolpopexy (ASC n=43, control n=147) or vaginal mesh procedure (VMP n=41, control n=105) with concomitant hysterectomy, concomitant hysterectomy was associated with mesh extrusion among women who had ASC (odds ratio , 3.18; 95% confidence interval  1.27 to 7.93, p=0.01) and VMP (OR 3.72, 95% CI 1.20 to 11.54, p=0.02).
In a retrospective non-randomised comparative study of 292 women treated by ASC (74 with concomitant hysterectomy, 218 with previous hysterectomy), the rates of mesh exposure were lower in women with previous hysterectomy (mesh erosion 53%  versus no erosion 76% , p=0.03) at a median followup of 42 months. Also, the study found that concomitant hysterectomy (mesh erosion 47%  versus no erosion 24% , p=0.03) or 3 or more additional procedures (mesh erosion 32%  versus no erosion 11% , p=0.02) increased the risk of mesh exposure.

## Robotic assisted sacrocolpopexy with concomitant hysterectomy
Mesh erosion rate after robotic assisted sacrocolpopexy (RASC) with a concomitant hysterectomy or RASC alone was not significantly different (2.7%  versus 5.1% ; p=0.50) in a retrospective non-randomised comparative study of 230 women at 6week followup. The 2.7% (3/79) of mesh exposures in the hysterectomy group were associated with total hysterectomy and none with supracervical hysterectomy (n=33), this difference was not significant (p=0.50). In another retrospective non-randomised comparative study, there was a mesh exposure rate of 14% (8/57) in the combined RASC with total hysterectomy group compared with 0% (0/45) in the RASC with supracervical hysterectomy group (p<0.01) at 3month followup. All erosions occurred at the vaginal apex.

## Laparoscopic sacrocolpopexy with concomitant hysterectomy
Mesh erosion rates were higher in women having conventional laparoscopic sacrocolpopexy (LSC) with concomitant total vaginal hysterectomy (TVH) compared with both robotic or conventional sacrocolpopexy after hysterectomy (23%  versus 5% ; p=0.003) and robotic LSC with supracervical hysterectomy (23%  versus 5% ; p=0.984) in a retrospective cohort study of 188 women (mean followup of 20 weeks). In multivariate regression analysis, the odds ratio of erosion for TVH done at the same time as sacrocolpopexy was 5.67 (95% CI 1.88 to 17.10; p=0.002) compared with sacrocolpopexy with concomitant hysterectomy.
Mesh exposure was more common when the vaginal cuff was opened, either in the course of hysterectomy or during vaginal attachment of mesh in women with a previous hysterectomy (4.9%  versus 0.5% ; relative risk  9.0; p=0.012) in a retrospective non-randomised comparative study of 390 women at a median followup 26 weeks. In women who had a concomitant hysterectomy, a higher mesh exposure rate was seen in open-cuff hysterectomy (TVH or laparoscopically assisted vaginal hysterectomy ) compared with supracervical hysterectomy (4.9%  versus 0% , p=0.032). Mesh exposure was more common when the mesh was sutured laparoscopically compared with transvaginally in women treated by open-cuff hysterectomy (14.3%  versus 2.7% ; relative risk, 5.4; p=0.013). There was no difference in exposure rates between TVH and LAVH groups (6.8%  versus 4% ; p=0.469).The rate of mesh complications was not significantly different among women who had TVH with LSC compared with women who had laparoscopic supracervical hysterectomy (LSCH) with LSC (1.6%  versus 1.7% ; p=1.0) in a retrospective non-randomised comparative study of 182 women with a median prospective followup of 9 months.
Extrusion of permanent suture was more common in women treated by LSCH with LSC compared with women treated by TVH with LSC (5.6%  versus 0.6% ; relative risk, 8.8; p=0.010) in a retrospective cohort study of 390 women. Most of these extrusions were asymptomatic and were managed non-surgically. The rate of suture erosion was not significantly different among women who had TVH with LSC compared with women who had LSCH with LSC (1% versus 2%; p=1.0) in the retrospective non-randomised comparative study of 182 women with a median prospective followup of 9 months.

## Other complications
Wound infection was reported in 8% (3/39) of women treated by hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review.
The presence of granulation tissue was not significantly different among women who had TVH with LSC compared with women who had LSCH with LSC (10% versus 7%; p=0.6) in the retrospective non-randomised comparative study of 182 women with a median prospective followup of 9 months. This was treated in the operating room.
Peri-vesical haematoma was reported in 5% (2/36) of women treated by sacrohysteropexy and 10% (4/39) of women who had hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review. The time of occurrence and further details were not reported.
Incisional hernia was reported in 5% (2/36) of women treated by sacrohysteropexy and 2% (1/39) of women who had hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review.
Severe abdominal pain because of bowel obstruction was reported in 1 patient in the LSCH+LSC group (n=59) in the non-randomised comparative study of 182 women. This was managed by small bowel resection and re-anastomosis of the bowel. The patient recovered completely and there was no evidence of mesh exposure.
Voiding dysfunction was reported in 11% (4/36) of women treated by sacrohysteropexy and 2% (1/39) of women who had hysterectomy with concomitant sacrocolpopexy in the non-randomised comparative study of 75 women included in the systematic review.
In addition to safety outcomes reported in the literature, specialist advisers are asked about anecdotal adverse events (events which they have heard about) and about theoretical adverse events (events which they think might possibly occur, even if they have never done so). For this procedure, specialist advisers listed the following anecdotal adverse event: osteomyelitis because of vagina being opened and inserting mesh.
Six commentaries from patients who had experience of this procedure were received, which were discussed by the committee.# Further information
For related NICE guidance, see the NICE website.

# Information for patients
NICE has produced information on this procedure for patients and carers (information for the public). It explains the nature of the procedure and the guidance issued by NICE, and has been written with patient consent in mind.
ISBN: 978-1-4731-2395-3