A prospective study of laparoscopic sacrocolpopexy for the management of pelvic organ prolapse

Authors


Dr CE North, Department of Urogynaecology, St Mary’s Hospital, Whitworth Park, Manchester M13 0JH, UK.
Email carolyn.north@ntlworld.com

Abstract

Objective  Assessment of the 2-year outcome of laparoscopic sacrocolpopexy.

Design  A prospective observational study of women undergoing laparoscopic sacrocolpopexy for prolapse.

Setting  A tertiary referral unit in the North West of England.

Population  A total of 22 women taking part in a prospective longitudinal study of prolapse who had a laparoscopic sacrocolpopexy between September 2002 and January 2005.

Methods  Women attended a research clinic where they completed validated quality-of-life questionnaires and were examined. Women were assessed preoperatively and postoperatively at 6 months, 1 year and 2 years.

Main outcome measures  Pelvic organ support assessed by Pelvic Organ Prolapse Quantification score. Assessment of the degree and impact of vaginal, urinary and bowel symptoms using validated quality-of-life questionnaires.

Results  At a mean follow up of 26.5 months, all 22 women had stage 0 vault support with 21 cured of prolapse symptoms. Stress urinary incontinence resolved in half of women without concomitant continence surgery. Bowel symptoms were uncommon, but of those reporting postoperative bowel symptoms, approximately one-third had no symptoms prior to surgery. No new onset dyspareunia was reported in those women sexually active at 2 years.

Conclusions  Laparoscopic sacrocolpopexy is a safe and effective treatment for vault prolapse, providing excellent vault support in the medium term. The outcome for anterior and posterior support is less predictable, and anatomical outcome correlated poorly with functional outcome.

Introduction

The incidence of symptomatic vault descent following hysterectomy is unknown. However, it is estimated to affect 0.2–43% of women1 and is more common in women for whom hysterectomy was performed because of symptoms of prolapse.2 Many women with vault prolapse can be successfully managed with the use of a vaginal pessary;3,4 however, where this fails or is declined by the woman, surgical management may be appropriate.

Numerous surgical procedures have been described for the management of vault prolapse, and few have been subject to rigorous assessment of their anatomical and functional outcome. Consequently, the optimal surgical approach remains controversial. Vaginal surgery may be associated with less postoperative pain and a more rapid return to daily living than abdominal repair.5,6 However, in a randomised study, sacrocolpopexy was twice as likely to result in optimal anatomical outcome as vaginal surgery.7

Laparoscopic sacrocolpopexy provides the potential to combine the success rates of an abdominal approach with the faster recovery associated with a minimally invasive technique. Tissue dissection and mesh placement may also be facilitated by the magnification and field of view permitted by the laparoscopic approach.8–11

Previous published results from this unit have concerned the short-term and long-term outcome of this procedure in 103 women.12,13 However, these reviews were retrospective and commenced before the introduction of the Pelvic Organ Prolapse Quantification (POP-Q) examination.14 The additional information provided by the use of validated quality-of-life questionnaires was also unavailable. We describe the 2-year follow up of a series of women from out unit who were part of a cohort participating in a long-term prospective longitudinal study of prolapse. A comprehensive objective assessment of outcome was undertaken with reference to anatomical outcome and vaginal, urinary and bowel symptoms, bother and quality-of-life scores using validated questionnaires.

Subjects and methods

This study was performed in a unit providing a tertiary referral urogynaecology service for the North West of England. A prospective longitudinal study of prolapse commenced in 2002. This study has NHS Research Ethics Committee approval (Central Manchester LREC 02/SM/326) and has been approved by the Trust’s Research and Development Department. The 22 women of this cohort who elected for surgical treatment by laparoscopic sacrocolpopexy are included in this report.

All surgery was performed by the senior author (A.R.B.S.). Polypropylene mesh was inserted laparoscopically with no vaginal incisions. Following dissection of the rectovaginal space to the level of the levator ani muscles, mesh was placed along the full length of the posterior vaginal wall in all women but was not extended along the anterior wall. The mesh was sutured in place with absorbable (Vicryl®) sutures. The cranial aspect of the mesh was secured to the sacral promontory with 5-mm tacks (ProTack; Tyco Healthcare, Norwalk, CT, USA). Twenty women underwent sacrocolpopexy with Premilene® mesh (B Braun, Tuttlingen, Germany). Two women underwent sacrocolpopexy with Mini-mesh® (Mpathy Medical Devices Ltd, Glasgow, UK). The selection of mesh was determined by availability. One woman underwent a concomitant tension-free vaginal tape (TVT) procedure. No other concomitant procedure, such as colporrhaphy, was performed.

Women were seen preoperatively and were then asked to attend at 6 months, 1 year and 2 years postoperatively. All women completed a Pelvic Floor Distress Inventory (PFDI) and a Pelvic Floor Impact Questionnaire (PFIQ). These questionnaires have been validated for use in women with prolapse and/or urinary incontinence and have demonstrated responsiveness to change following surgery for prolapse.15,16

An examination for prolapse was performed using the POP-Q system. All women were asked to empty their bladder prior to the examination, which was performed in the lithotomy position, semi-recumbent. Women were asked to perform a maximal valsalva effort. Maximal prolapse was confirmed by asking the woman to confirm, by touch, that the vaginal bulge was maximal and/or by observing taut, shiny vaginal epithelium. Those unable to generate a maximal valsalva were examined during a forceful cough.

Results

In the results of this study, all averages are presented as the arithmetic mean (SD).

The average age of women at the time of surgery was 63.5 years (8.4). The average parity was 2.6 (0.65). Average body mass index (BMI) at the time of surgery was 28.8 kg/m2 (3.9) with nine women having a BMI of 30 kg/m2 or more. All 22 women had previously undergone hysterectomy with 23% having had a vaginal hysterectomy and 69% by the abdominal route. The number of previous procedures for prolapse ranged from 1 to 5 and consisted entirely of colporrhaphy with the exception of one woman who had undergone sacrospinous fixation. Two women had previously undergone surgery for stress urinary incontinence with one having had a colposuspension and one having had a fascial sling procedure.

Average postoperative inpatient stay was 3 days (1.3). Immediate and short-term complications were uncommon. One woman with dense adhesions between the vault and the bladder sustained a cystotomy during adhesiolysis. This was immediately repaired, and a urethral catheter was left in situ for 7 days. The woman experienced an otherwise uneventful recovery. One woman was treated as an outpatient for a vault infection during the first 2 weeks following surgery.

There was one medium-term complication during the period of follow up; one case of Premilene mesh extrusion at the vault. This presented at 13 months with dyspareunia, ‘hispareunia’17 (complaint of pain on intercourse from the patients’ partner) and vaginal bleeding. An area of mesh extrusion measuring approximately 0.5 cm was found on the right side of the posterior vaginal wall, 2 cm distal to the vault. Medical treatment, with topical estrogen cream and oral antibiotic therapy, was unsuccessful, and surgical excision, of the extruded piece of mesh only, was performed by a combined laparoscopic and vaginal approach without compromising vaginal support. The woman was asymptomatic at review at 29 months.

Follow up was performed at an average of 27.5 months (3.3). A structured interview and POP-Q examination was performed in all 22 women. All women completed a preoperative and postoperative PFIQ. All women completed a preoperative PFDI; however, one woman refused to complete a postoperative PFDI.

The POP-Q stage data are presented in Table 1. It demonstrates that at 2 years, all women had stage 0 vault support. One woman underwent laparoscopic sacrocolpopexy primarily to manage her recurrent posterior compartment prolapse, having stage 0 vault support. Although seven women had stage 1 vault support preoperatively, it should be remembered that this stage includes women for whom the leading edge of the vault does not reach 1 cm above the hymenal remnant. Thus, the vault may be prolapsed clinically to a significant extent and yet be measured as stage 1. This may demonstrate a limitation of the POP-Q scoring system.

Table 1.   POP-Q stage at baseline and at 2 years
 PreoperativeTwo years
Apical
Stage 0122
170
220
3100
420
Anterior
Stage 0010
107
254
3151
420
Posterior
Stage 035
145
248
3104
410
Overall
Stage 002
104
2411
3165
420

Overall stage improved in 15 women. Although 11 women had a POP-Q stage 2 at 2 years, the leading edge of the prolapse lay above the level of the hymenal remnant in seven women. The stage of the anterior compartment improved in 21 women and posterior compartment stage improved in 11 women.

Preoperatively, all women had complained of a sensation of bulging or protrusion from the vagina and all had a lump that they could either see or feel. These symptoms were bothersome, with an average preoperative score of 3.7 (0.5) on PFDI (maximal score for bother is 4). Average postoperative score was 0.7 (1.2) with the majority of women experiencing a complete resolution of their symptoms of a lump. One woman had no improvement in the sensation of a lump, scoring 4 on both occasions. This score persisted despite resolution of her vault prolapse, rectocele and improvement of her anterior compartment support from stage 3 to 1 (with the leading edge of the prolapse at the hymenal remnant).

Eleven women were sexually active preoperatively, 2 of whom complained of dyspareunia. At 2 years, this had resolved in one woman. The other was no longer sexually active due to her husband’s ill health. Three additional women were no longer sexually active at 2 years. One woman reported reduced libido as the reason for her lack of sexual activity, and the reason for the discontinuation of sexual activity is not recorded in the remaining two women. Two women had resumed sexual activity since their surgery. At the 2-year visit, no women reported new onset dyspareunia.

The change in urinary symptoms is shown in Table 2. Although preoperative urodynamic studies were not part of the protocol, 77% had urodynamics prior to surgery. Of those who complained of bothersome symptoms, urodynamic stress urinary incontinence (USI) was demonstrated in one woman. This woman underwent concomitant TVT and had resolution of her stress incontinence at 2 years. Three women had asymptomatic USI on preoperative urodynamic studies, of which none had become symptomatic at 2 years. Complaints of stress incontinence at 2 years were not associated with the degree of prolapse of the anterior compartment.

Table 2.   Change in urinary symptoms at 2 years
Symptom and relevant question on PFDINumber affected preoperativelyChange following surgery
Voiding difficulties
‘Do you usually experience difficulty emptying your bladder?’1211 improved
1 present but unchanged
0 deteriorated
0 arisen de novo
‘Do you ever have to push up on a bulge … to start or complete urination?’76 improved
1 present but unchanged
0 deteriorated
1 arisen de novo
Stress incontinence
‘Do you usually experience urine leakage related to coughing, sneezing or laughing?’137 improved
4 present but unchanged
2 deteriorated
3 arisen de novo
Urinary urgency
‘Do you usually experience a strong feeling of urgency to empty your bladder?’158 improved
6 present but unchanged
1 deteriorated
1 arisen de novo
Urge incontinence
‘Do you usually experience urinary leakage associated with a feeling of urgency …?’158 improved
4 present but unchanged
2 deteriorated
2 arisen de novo

The change in bowel symptoms is shown in Table 3. One woman complaining of bothersome symptoms of obstructed defecation preoperatively underwent a defecating proctogram. This revealed an anterior rectocele and a mid-third circumferential rectal mucosal prolapse. She elected to proceed with laparoscopic sacrocolpopexy without additional rectopexy and her symptoms resolved following surgery. The presence of any bowel symptom, including the complaint of obstructed defecation, at 2 years was not associated with the degree of prolapse of the posterior compartment.

Table 3.   Change in bowel symptoms at 2 years
Symptom and relevant question on PFDINumber affected preoperativelyChange following surgery
Difficult defecation
‘Do you feel you need to strain too hard …?’107 improved
2 present but unchanged
1 deteriorated
2 arisen de novo
‘Do you usually have to push up on the vagina … to have or complete a bowel movement?’139 improved
2 present but unchanged
2 deteriorated
1 arisen de novo
Anal incontinence
‘Do you usually lose stool beyond your control if your stool is well formed?’22 improved
0 present but unchanged
0 deteriorated
0 arisen de novo
‘Do you usually lose gas from the rectum beyond your control?’94 improved
4 present but unchanged
1 deteriorated
3 arisen de novo
Urgency
‘Do you experience a strong sense of urgency…. to have a bowel movement?’86 improved
1 present but unchanged
1 deteriorated
2 arisen de novo

The average preoperative and postoperative PFDI and PFIQ scores are shown in Table 4 and demonstrate wide variation. However, the change is statistically significant when analysed using a paired t-test. The change seen in particular subscales of the PFDI is shown in Table 5. These subscales were analysed in detail given their particular relevance to vault prolapse and the effect of sacrocolpopexy. All showed a reduction in average score at 2 years.

Table 4.   Average scores for PFDI and PFIQ preoperatively and at 2 years
 Preoperative (n= 22)Two years postoperative (n= 21)p value
PFDI (n=22)
Urinary distress inventory107 (70)56 (54)<0.05
POP distress inventory143 (70)61 (68)<0.05
Colorectal-anal distress inventory96 (77)57 (55.5)<0.05
PFIQ (n=21)
Urinary impact questionnaire193 (93)153 (79)<0.05
Colorectal-anal impact questionnaire176 (102)129 (62)<0.05
POP impact questionnaire211 (99)132 (79)<0.05
Table 5.   Average change in PFDI subscales of particular interest
Urinary impact questionnaire
Obstructive subscale−35 (15)
Irritative subscale−11 (21)
Stress subscale−7.5 (33)
POP distress inventory
General subscale−40 (26)
Colorectal-anal distress inventory
Obstructive subscale−20 (37)
Incontinence subscale−10 (23)

Discussion

Since it was first described in 1992,18 numerous authors have published their experience of laparoscopic sacrocolpopexy for the management of post-hysterectomy vault prolapse.8,19–25 However, such series have been, for the most part, small and retrospective in nature.

A previous retrospective review of 66 women at our unit13 raised questions with regard to the effect of laparoscopic sacrocolpopexy on bladder, bowel and sexual function. Therefore, a prospective study was initiated, and although a relatively small number of women are included, it benefits from using validated measures of anatomical outcome and quality of life. The mean follow up of 27.5 months allows assessment of medium-term outcomes. A longer follow-up period is needed to draw firm conclusions with regard to the rate of recurrent prolapse. The follow-up period is also too short to reveal all mesh complications as this can occur many years following surgery. Extrusion of mesh into the vagina occurred up to 3 years following surgery in our previous retrospective analysis,13 and extrusion of mesh following TVT has occurred 5 years following surgery.26

This prospective study provides further evidence that laparoscopic sacrocolpopexy provides good vault support in the medium term with all 22 women having stage 0 apical support at 2 years. Intraoperative complications were rare, and no women required return to theatre. The only medium-term complication was one case of mesh extrusion requiring surgical excision as part of the mesh. This is in agreement with the 3–9% rate of mesh extrusion previously reported for sacrocolpopexy by either the open or laparoscopic route.9,13,27–29

Although laparoscopic sacrocolpopexy provides excellent vault support, the outcome for anterior and posterior compartment support is less predictable. Five women had anterior compartment prolapse of stage 2 or greater, and 12 women had stage 2 or greater posterior support at 2 years. This <0.05 occurred despite attachment of the distal edge of the mesh to the levator ani muscles at the time of surgery in all women, which has been reported to reduce posterior compartment recurrence.9,30 The rate is comparable to the rate of nonvault prolapse previously reported from our unit.13 However, only 1 of the 22 women complained of a vaginal lump that she could see or feel. This replicates the findings of other studies that have shown that ‘perfect’ support is not required for the relief of prolapse symptoms. None of the women required further treatment for prolapse, either surgical or with a vaginal pessary, during the follow-up period.

Retrospective analysis has previously demonstrated that urinary symptoms improved in approximately 30% of women having laparoscopic sacrocolpopexy and worsened in approximately 15%, with the reminder being unchanged. In that cohort, a concomitant colposuspension was performed in almost 40%.13 The performance of routine concomitant continence procedures at the time of abdominal sacrocolpopexy remains an area of controversy with two recent prospective, randomised trials of colposuspension at the time of abdominal sacrocolpopexy achieving very different results.31,32 Some of this difference may be associated with the degree of anterior mesh placement performed during the sacrocolpopexy, with some surgeons routinely extending the mesh anteriorly and others not. There are no randomised studies of continence procedures at the time of laparoscopic sacrocolpopexy.

In this study, only one woman had a concomitant TVT. She was the only patient in the cohort to have bothersome symptomatic USI preoperatively. None of the three women with asymptomatic USI developed such symptoms postoperatively. No women required treatment for stress incontinence during the follow-up period. The risk of symptoms of postoperative stress incontinence was not predicted by preoperative symptoms. Half of those with preoperative symptoms of stress leakage reported improvement of their symptoms at 2 years. This mirrors our anecdotal experience that postoperative stress incontinence often improves spontaneously in the year following laparoscopic sacrocolpopexy. This has been assumed to be related to a degree of ‘relaxation’ of anterior compartment support. However, in this study, no clear relationship was identified between preoperative or postoperative anterior compartment support and the risk of symptoms of stress incontinence at 2 years.

The data with regard to functional outcome for the bowel following laparoscopic sacrocolpopexy remain unclear. Dissection of the rectum from the posterior vaginal wall during mesh placement may adversely affect bowel function. Ross and Preston9 report improvement in symptoms of chronic constipation but no significant change in faecal incontinence at 5 years following laparoscopic sacrocolpopexy. Higgs et al.13 reported new onset bowel symptoms in one-third of women following laparoscopic sacrocolpopexy.

In this prospective study, the majority of women with preoperative bowel symptoms reported improvement following surgery. Transient ‘constipation’ occurred commonly in the weeks immediately after surgery but has resolved by 6 months. A small number of women developed symptoms of obstructed defecation or flatal incontinence after the procedure. During our laparoscopic sacrocolpopexy, the mesh is cut ‘bespoke’ for each woman, and the distal edge of the mesh is cut to a ‘trouser-leg’ shape in the belief that this may reduce the risk of obstructing the passage of any hard stool through the rectum. However, the number of women complaining of bowel symptoms in this study was small, and it was not possible to analyse the contribution from the shape of the mesh.

The low rate of postoperative dyspareunia in this study was surprising. A previous study from our unit reported 44% postoperative dyspareunia.13 However, sexual function was not well documented preoperatively, making it difficult to draw firm conclusions about the effect of surgery on sexual function. In this study, women were asked whether they were sexually active and, if so, whether they had any coital difficulties including dyspareunia and hispareunia. The reason for sexual inactivity was not clear in all women. It is a weakness of the study that a condition-specific questionnaire with regard to sexual function, such as pelvic organ prolapse urinary incontinence sexual questionnaire (PISQ),33 was not used. Of interest, it was noted that during the period of follow up, participation in sexual activity appeared to change with women reporting different answers to questions regarding their sexual activity at each visit. The reason for this is unknown and may reflect changing relationships or the variable health of their partner, which is known to be a major determinant in whether women with prolapse are sexually active.34 It does demonstrate that questions regarding sexual function need to be asked at each clinic visit, and it cannot be assumed that just because a woman is not sexually active preoperatively that she will remain so.

The condition-specific, quality-of-life questionnaires selected for this study have been validated for use in North American women with pelvic floor disorders, where they have demonstrated responsiveness following treatment for prolapse with both a vaginal pessary and a vaginal reconstructive surgery.16 The PFDI and PFIQ have not been specifically validated for the UK population. The minimal clinically important difference (MCID) has also not been calculated for these questionnaires, which makes it difficult to analyse what changing scores after surgery mean for our women. We did, however, demonstrate a significant reduction in average scores for all scales and subscales of these questionnaires at 2 years following laparoscopic sacrocolpopexy compared with scores preoperatively, suggesting an improvement in quality of life and a reduction in bother. However, the change in score did not correlate with the change in POP-Q. For example, one subject demonstrated an improvement from stage 4 to 1 prolapse but had an increase in POP distress inventory and POP impact questionnaire scores at 2 years compared with baseline.

Conclusions

This is a prospective study of laparoscopic sacrocolpopexy using both POP-Q measurements of anatomical outcome and a validated quality-of-life questionnaire. Our results suggest that laparoscopic sacrocolpopexy is a safe and effective surgical treatment for post-hysterectomy vault prolapse, which provides excellent vault support in the medium term. Mesh complications were uncommon. Functional outcome of the bladder and bowels is difficult to predict, either on preoperative symptoms or on urodynamic studies. In contrast to some studies of open sacrocolpopexy, half of women complaining of stress urinary incontinence found their symptoms improved following sacrocolpopexy alone, without additional continence surgery. Postoperative bowel symptoms were uncommon. However, approximately one-third of those who complained of bowel symptoms postoperatively had no bowel symptoms before surgery. There was a significant decrease in PFDI and PFIQ scores following surgery, suggesting improved quality of life, although the MCID for these tools remains unclear. Overall, results were comparable to our previous retrospective review with the exception of postoperative dyspareunia, which appeared less frequent than previously reported. The inclusion of a validated tool, such as PISQ, in further studies will be important in clarifying the effect of laparoscopic sacrocolpopexy on sexual function.

Disclosure of interest

The salary of C.E.N. and N.S.A.-R. has been, in part, funded by a grant from MPathy Medical Devices Ltd, Glasgow, UK who manufactures Mini-mesh. MPathy Medical Devices were not involved in any part of the study.

Contribution to authorship

C.E.N. was responsible for the acquisition of data and was involved in the analysis and interpretation of the data. She was substantially involved in the drafting, revision and final approval of the manuscript. N.S.A.-R. was responsible for the conception and design of the study. She was also responsible for the acquisition and analysis of the data. She was involved in the revision and final approval of the manuscript. A.R.B.S. was jointly responsible for the conception and design of the study. He was involved in the interpretation and analysis of the data. He was substantially involved in the drafting, revision and final approval of the manuscript. F.M.R. was involved in the interpretation and analysis of the data. She was substantially involved in the drafting, revision and final approval of the manuscript.

Details of ethics approval

This study forms part of a larger prospective, observational study on women with pelvic organ prolapse. It has approval from the local research ethics committee (reference number 02/SM/326).

Funding

This study was performed without specific funding. However, the salary for C.E.N. and N.S.A.-R. was partly funded by a grant from MPathy Medical Devices, as detailed in the conflict of interest.

Acknowledgement

The authors would like to thank Dr P Higgs for her help in collecting some of the preoperative data.

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