Vaginal Repair with Polypropylene Mesh Compared to Traditional Colporrhaphy for Pelvic Organ Prolapse: Medium-Term Follow-Up

Abstract

Objective: The aim of this study was to compare vaginal repair augmented by mesh with traditional colporrhaphy for the treatment of pelvic organ prolapse. Design: This was a single-center prospective cohort observational study. Materials and Methods: We prospectively recruited patients undergoing vaginal mesh (n=41) and traditional colporrhaphy (n=44) at a university hospital in the United Kingdom. The validated ICIQ-VS questionnaire was completed preoperatively and up to 3 years postoperatively. Results: Improvement in the mean of the symptom scores in the mesh group was −18.75 (SD=−9.731) compared to −12.88 in the no-mesh group (SD=12.065, p<0.003). The change in mean visual analogue scores for ‘bother’ of symptoms in the mesh group was −14.9 (SD=−7.992) compared to −8.3 in the no-mesh group (SD=−5.945, p<0.000056). A negative change indicates a decrease in score over time, and improvement in symptoms. There were significant improvements with mesh compared with traditionally treated patients only with regard to vaginal soreness and dragging pain. In the mesh group, the exposure rate was 10% (n=4). Both groups had statistically significant improvements in all their postoperative symptoms except for the symptoms of vaginal dryness and vaginal sensation in the traditional group. Conclusions: There were statistically significant improvements in all symptoms in the mesh category. In the traditional repair group, there were statistically significant improvements in all symptoms except for vaginal sensation and a dry vagina. Comparison revealed statistical significant improvements in favor of mesh only with regard to the symptoms of a sore vagina and of dragging pain. (J GYNECOL SURG 29:1)

Introduction

There is increasing interest and debate surrounding the most appropriate type of surgery for the treatment of vaginal prolapse.¹ There are advocates for both the use of vaginally inserted mesh and for the continued use of traditional methods of vaginal repair. Evidence for the efficacy of vaginal mesh is increasing with case series,² randomized controlled trials^3–6 and reviews.^7,8 More evidence is required to determine when mesh may have benefit over traditional repair or indeed whether its use should be abandoned. The U.S. Food and Drug Administration (FDA) has recently issued a safety communication about the use of all vaginally placed mesh, both for incontinence and prolapse.⁹ This has sparked increased deliberation regarding the issues of safety, complications, and use of mesh, with each side of the debate making cogent arguments for their perspective views.^1,10–13

What is clear is that pelvic organ prolapse is not going away. There is evidence that the average life expectancy for humans is relentlessly increasing from an estimated 20 years of age in the Neolithic Age (10,200 BC) to 20–30 years in Medieval Britain, 30–40 years in the early 20th century, and 70 years and higher now in the developed world.¹⁴ This will lead to an increasing burden in caring for a progressively ageing population of women. If 7% of women have a prolapse operation in their lifetime^15,16 and a proportion of these a repeat operation, then in order to reduce re-operation rates, healthcare time, and expenditure, we need to develop treatments that are more likely to work on a first-time basis with long-term efficacy. What is certain is that we cannot stand still, as our present treatments may not be cost-effective over the lifetime of an ageing population, with an expected doubling in the incidence of prolapse surgery occurring in the next 30 years.¹⁷ Therefore more effective treatments are required using either improved standard techniques or mesh products. The mesh debate may be healthy in pushing both treatments forward.

Present estimates of the incidence of prolapse include rates of 14.2% for uterine prolapse, 34.3% for cystocoele, and 18.6% for rectocele,¹⁸ with some estimates of the incidence of rectocoele being as high as 80%.¹⁹ Rates of standard surgical failure vary widely, with some studies reporting anatomic recurrence of cystocoele after standard surgery of 12% at 3 months, with a re-operation rate of 3.4% at 50 months.²⁰ However, others are not quite so reassuring with anatomic failure rates of 41%–43% at 5 years and 1 year respectively.^21–23 Randomized controlled trials comparing mesh and traditional surgery for anterior colporrhaphy have generally shown superior benefit for the mesh groups, with success for the mesh at 1 year being 60.8%–92.5% and with traditional surgery being 34.5%–61.5%,^3,4,6,23 although some have not shown a difference.⁵ There is still the need for increasing comparative evidence comparing mesh and traditional surgery, although it has been recognized that this does not always mean randomized trials.²⁴ This study compares two cohorts operated on in the same unit by the same surgical team. The mesh cohort, with the surgical technique documented, has already been reported.² We then felt it important to survey a similar group of patients undergoing traditional vaginal repair by the same team for comparison.

Materials and Methods

This was a single-center prospective observational study performed at a university hospital in the UK. It involved the prospective symptom assessment of 41 consecutive patients who underwent anterior and/or posterior Avaulta Plus or Avaulta Biosynthetic Support System (BARD) repairs, and 44 patients who had a traditional anterior or posterior colporrhaphy. Women with a prolapse of stage 2 or more according to Baden–Walker staging were prospectively audited, as is the normal procedure for all women undergoing prolapse surgery in this unit. Multichannel urodynamics was performed on subjects with urinary stress incontinence prior to surgery. If a tension-free vaginal tape (TVT) was required, this was undertaken at the end of surgery. The validated International Consultation on Incontinence Modular Questionnaire—Vaginal Symptoms (ICIQ-VS) was used to analyze and quantify the various types of symptoms.² The questionnaire was completed in the clinic preoperatively, and postal questionnaires were sent to patients up to 3 years postoperatively. For each different symptom's effect on quality of life (QoL), severity was assessed using a visual analog scale (VAS) of 0 to 10. This study was considered as a clinical surgical audit for service evaluation, and formal institutional review board approval was not required. The surgical technique varied according to the site of the pelvic organ prolapse.

For the standard anterior and posterior colporrhaphy groups, a midline incision was performed, and the prevesical or prerectal tissue was dissected from the vaginal epithelium and plicated with two layers of 2-0 polydioxanone. Excess vaginal epithelium was excised as required and closed with a nonlocking running suture with 1 polysorb. Our Avaulta technique has been described previously.² Comparison between baseline and follow-up data was analyzed using a paired sample test by an independent statistician. The mesh used was monofilament, polypropylene, porous, and acellular with an ultrathin sheet of cross-linked collagen. We used both Avaulta and Avaulta Plus meshes. Both meshes contain similar properties, and the principles of the procedures were the same, although the Avaulta Plus is more operator friendly with easier insertion of trocars.

Results

In the mesh group, 41 women were recruited prospectively with follow-up of up to 3 years (median 27 months). We had responses from 40 people (97.5% response rate). In the standard repair group, 44 women were prospectively recruited with follow-up of up to 3 years (median 24 months). Forty-two women in this group responded (95% response rate). The main outcome measure was subjective success using the validated ICIQ-VS questionnaire. This included VAS of the bother of various vaginal symptoms. Secondary outcome measures were complications. In the mesh group, the mean age was 67. 9 years compared to 65.2 years in the no-mesh group. In total, 12 (30%) women had mesh as a secondary procedure. We considered it a secondary procedure if the previous repair was in the same compartment or if they had previous surgery for vault prolapse (Table 1). Of the 40 mesh patients available for follow-up, 19 (47.5%) had an anterior mesh, 20 (50%) a posterior mesh, and 1 (2.5%) had both anterior and posterior mesh repairs.

Table 1.

Details of Previous and Present Pelvic Operations in the Mesh Group

Total number (N=40)

Anterior Avaulta total 19 patients, total who had previous surgery is 26% of this group

Previous surgery: n (26.3% of the anterior group)

Anterior repair: 2 (10.5%)

Anterior repair and sacropcolpopexy (SCP): 1 (5.3%)

Anterior repair and sacrospinous fixation (SSF): 1 (5.3%)

SCP alone: 1 (5.3%)

Posterior Avaulta total 20 patients, total who had previous surgery is 35% of this group

Previous surgery: n (35% of the posterior group)

Posterior repair: 3 (15%)

Posterior repair and SCP and SSF: 1 (5%)

Posterior repair and pelvicol mesh and culdoplasty: 1 (5%)

Para vaginal repair+SCP: 1 (5%)

Sacrospinous fixation: 1 (5%)

Anterior and posterior Avaulta, no previous surgery: 1

None of the patients in the standard repair group had previously undergone vaginal repair in the same compartment. In this group, 28 (67%) underwent anterior repair, 11 (26%) a posterior repair, and 3 (7%) both anterior and posterior repairs. If stress urinary incontinence was present, a midurethral tension-free tape (Gynaecare TVT) was inserted at the end of the procedure. All of these patients had preoperative urodynamics indicating urodynamic stress incontinence.

Preoperatively, 20 (50%) women in the mesh group complained of a sore vagina, and at follow-up, only 1 (2.5%) had this symptom (p=0.0001). In the repair group preoperatively, 25 (60%) patients had vaginal soreness, and at up to 3 years follow-up, 15 (36%) still had this symptom (p=0.0289). Comparing the mesh with no mesh, there was a statistically different improvement in vaginal soreness in the mesh group (p=0.0004). In the mesh group preoperatively, 27 (67.5%) and 12 (30%) had a lax vagina and reduced vaginal sensation respectively. At follow-up, this was reduced to two (5%) and three (7.5%) respectively (p=0.0001 and 0.01). Similarly, in the repair group preoperatively, 20 (48%) and 13 (31%) patients had a lax vagina and reduced vaginal sensation respectively. At follow-up, this was reduced to five (12%) and eight (19%) respectively (p=0.0003 and 0.2077). Comparing the mesh with no mesh, there was no statistical difference for these symptoms. In the mesh group preoperatively, 13 (32%) patients were not sexually active due to their vaginal symptoms, whilst at follow-up, all of these women had resumed sexual activity (p=0.0001). In the repair group, three (7.5%) patients were not sexually active due to their vaginal symptoms. At follow-up, all of these women had resumed sexual activity (p=0.0009). Comparing the mesh with no mesh, there was no statistical difference for this symptom (p=1). At follow-up in the mesh group, 1 (2.5%) out of the 40 women had symptoms of prolapse (lump or bulge in or out of the vagina; p=0.0001). Three (7%) out of the 42 women in the standard repair group had symptoms of prolapse at follow-up (p=0.0001). Comparing the mesh with no mesh for the symptom of feeling a lump or bulge in or out of the vagina, there was no significant difference (p=0.6441). Preoperatively, 12 (57%) out of 21 women who had a posterior mesh needed to digitate the vagina to empty their bowels. At follow-up, only two patients (9.5%) still needed to digitate to empty their bowels (p=0.0001). In the standard group, 4 out of 14 (28%) patients who underwent a posterior repair needed to digitate the vagina to empty their bowels initially, and at follow-up, none of them had this symptom (p=0.0308). Comparing the mesh with no mesh, there was no statistical difference for this symptom (p=1). Preoperatively, 22 (55%) and 16 (40%) women in the mesh group experienced dragging and a dry vagina respectively. At up to 3 years follow-up, only one (2.5%) and two (5%) patients had these symptoms (p=0.0001 and 0.0001). On the other hand, in the repair group preoperatively, 31 (74%) and 14 (33%) patients had dragging pain and a dry vagina respectively, and at 3 years follow-up, 11 (26%) and 7 (17%) patients had these symptoms respectively (p=0.0001 and 0.0778). Comparing the mesh with no mesh, there was a statistically significant improvement in dragging pain in the mesh group but not for a dry vagina (p=0.0204 and 0.0662).

The change in the cumulative mean symptom score of all symptoms preoperatively to follow-up in the mesh group was −18.75 compared to −12.88 with no mesh (p=0.0003). The change in cumulative mean VAS score of the bother of symptoms in the mesh group was −14.9 (SD=−7.992) compared to −8.3 with no mesh (SD=−5.945, p=0.000056). A negative change indicates a decrease in score over time and therefore improved symptoms. For a summary of the results, see Table 2. In the mesh group, the exposure rate was 10% (n=4), all less than 1 cm diameter in the midline. These were treated as day case procedures. No major complications were documented with either group.

Table 2.

Summary of Results and Comparative Statistics

Symptoms	Preop Avaulta mesh (n=40) % (n) with symptoms	3 years Avaulta mesh (n=40) % (n) with symptoms	Avaulta p value	Preop no mesh (n=42)% (n) with symptoms	3 years no mesh (n=42) % (n) with symptoms	No mesh p value	Preop to 3 years Avaulta: Improvement in number with no symptoms	Preop to 3 years no mesh: Improvement in number with no symptoms	p Value mesh vs. no mesh
Sore vagina	50% (20)	2.5% (1)	0.0001	60% (25)	36% (15)	0.0289	−19	−10	0.0004^*#
Lax vagina	67.25% (27)	5% (2)	0.0001	48% (20)	12% (5)	0.0003	−25	−15	0.2077^*
Vaginal sensation	30% (13)	7.5% (3)	0.01	31% (13)	19% (8)	0.2077	−10	−5	0.1510^*
No sex life due to vaginal symptoms	32.5% (13)	0% (0)	0.0001	7% (3)	0% (0)	0.0009	−13	−3	1^*
Lump in or out of the vagina	100% (40)	2.5% (1)	0.0001	100% (42)	7% (3)	<0.0001	−39	−39	0.6441^*
Digitation to empty bowels	12 out of 21 (57%)	(9.5%) 2 out of 21	0.0001	(28%) 4 out of 14	0 out of 14 (0%)	0.0308	−10	−4	1^*
Dragging pain	55.5% (22)	2.5% (1)	0.0001	74% (31)	26% (11)	<0.0001	−21	−20	0.0204^*#
Dry vagina	40% (16)	5% (2)	0.0001	33% (14)	17% (7)	0.0778	−14	−7	0.0662^*
QOL mean change from preoperative to 3 years (SD)				−18.88 (9.731)			−12.88 (12.065)		0.003

In summary, there were statistically significant improvements in all symptoms in the mesh category. In the traditional repair group, there were statistically significant improvement in all symptoms except for vaginal sensation and a dry vagina. Comparison between the groups revealed statistical significant improvements in favor of mesh only with regard to symptoms of a sore vagina and of dragging pain.

Discussion

To our knowledge, this is the first report of mesh repair with Avaulta and Avaulta Plus Biosynthetic Support Systems compared with standard repair documenting medium-term outcomes at up to 3 years of follow-up, as compared to several RCTs on different vaginal mesh systems but mostly with short-term outcomes.^3,5,22,23 The questionnaire used in this audit is validated and based on symptoms, perhaps the most important measure for patients.²⁵ In our series, important questions such as vaginal soreness, dragging pain, reduced vaginal sensation, vaginal dryness, and laxity were all improved in the mesh group. Similar findings were observed in the traditional repair group except that there was no significant difference in the symptoms of vaginal sensation and a dry vagina between the preoperative and postoperative assessments. The bother of these symptoms also greatly decreased at follow-up in both groups. There was only a significant difference in favor of vaginal mesh for the symptoms of a sore vagina and of dragging pain. Symptoms of a dry vagina improved by 87% in the mesh group compared to 48% with no mesh. It is possible that this may have been confounded by more usage of topical estrogens preoperatively in the mesh group. What seems clear is that both techniques offer significantly improved symptom relief at follow-up, with mesh showing some additional benefits. There has been concern that vaginal mesh procedures may increase the incidence of postoperative dyspareunia. However, we did not find this.

Lack of new cases of a sore vagina or sexual dysfunction in the mesh group may be due to small incisions, deeper vaginal dissection, tension free placement, flat placement, and perhaps most importantly no vaginal skin excision (trimming of the vaginal mucosa was limited to only mucosal edges if significantly damaged by instrumentation). We may have expected more symptoms of a sore vagina or sexual dysfunction in the traditional group due to the tightening effect of excision of vaginal tissue and support of the underlying fascia, which may lead to narrowing and shortening of the vagina with a standard repair. That this did not occur is encouraging for the particular traditional repair we have adopted. Other reports have also shown no impairment in sexual function 1 year after transvaginal polypropylene mesh repair^8,26–28 and similar rates of pain and satisfaction during intercourse between the two surgical methods.^3,5,6,8

At long-term follow-up, only one woman (2.5%) in the mesh group one had symptoms of prolapse. In the standard repair group, three women had symptoms of prolapse. We have to remember that in the mesh group, 12 patients had previously undergone prolapse surgery in the same compartment, and in addition, when performed as a primary procedure, mesh was often used on the worst anatomical defects. Therefore the mesh was used in the most difficult cases, that is, repeat surgery or the most significant prolapse. There appears to be more acceptance of mesh in the difficult repeat case, but should we be offering mesh as the standard for primary surgery in order to reduce the general risks of repeat procedures over a lifetime? A lot of mesh surgery has to date been in either the very large primary prolapse or in repeat cases. It is therefore even more striking that anatomical and subjective success is reported to be so impressive. One must also consider that mesh exposure will undoubtedly be higher with repeat surgery, as the tissue is generally thinner and more scarred—just the sort of tissue that ideally one would normally like to avoid placing mesh in! Despite this, exposure rates are commonly reported as around 10%, but in our practice it reduced with experience. So mesh is used on the hardest cases and still appears to have impressive success.

Although this was not a randomized trial, patients were prospectively followed up and all patients were operated on by the same surgical team. This gives a degree of internal control but not of course the degree of rigor of a randomized controlled trial. What is surprising is that the overall subjective patient satisfaction (objective measures were not used) was in the most part the same. This fits with the randomized trial of Carey⁵ but not with other trials where mesh was significantly more efficacious,³ as with the finding of a recent Cochrane Review for anterior prolapse.⁸ Our results with mesh are similar to studies where success rates for polypropylene mesh range from 71%,²⁹ 87%,⁶ 93%,³⁰ to 95%.³¹ In the NICE (National Institute of Clinical Excellence) systematic review comprising 10 RCTs on anterior compartment mesh, the objective failure rate was 30% for procedures without mesh, and 14% for polypropylene mesh. When all studies were included, the objective failure rate for traditional surgery was 29% compared to 9% for mesh surgery.⁷ Many studies indicate high rates of failure with standard repair (hence the development of mesh techniques). For example, one study reported anatomic recurrence in 41% of patients with standard techniques, with a reoperation rate of 9.7%,²¹ and another showed a failure rate of 43%.²²

In our series, no patient who had a posterior mesh reported symptoms of a prolapse at follow-up. This compares favorably and consistently with the results of abdominal sacrocolpopexy (SCP) at 94%²¹, 94.6%²² and vaginal sacrospinous fixation at 91%,²¹ which may be performed for similar indications, for example vault prolapse and/or rectoenterocoele. However, vaginal mesh procedures are less invasive with quicker recovery with the possibility of day case treatment. Vaginal surgery has historically been deemed safer than abdominal procedures³² and has the potential benefit over SCP of not entering the abdomen. By entering the abdomen, there are risks of bowel injury other than the rectum, bowel obstruction quoted as 2% in laparoscopic and 3% in open procedures, wound herniation, conversion to a laparotomy, vascular and bladder injury, osteomyelitis, and injury to major vessels.³³

This comparative study has not indicated a significant benefit in the medium term for mesh procedures over our traditional repair technique. It is therefore of importance for further studies to determine the clinical scenarios whereby mesh repair may have a benefit over standard treatments. Confounding factors are that the mesh was generally used for repeat or larger prolapses, perhaps where traditional surgery may have had poorer results. Only large randomized trials are likely to answer this question. We may have to balance early morbidity for long-term benefit, for example an operation with more initial complications that works over a longer time course may, over a lifetime, be preferable. Such an operation may relieve symptoms for longer, improve quality of life over an extended period, and result in less repeat surgery with all of the additional anesthetic and surgical risk that would transpire from such surgery. We must also remember that the “gold standard” for vault surgery, SCP, only has studies with follow-up of a maximum of 5 years,³³ a remarkable state of events for an operation with its long history. We must not make the same mistakes with present studies, with ethical requests taking into account long-term follow-up over at least 10 years.

In this series, our mesh exposure rate was 10% (n=4), all less than 1 cm in diameter on the suture line, treated as day case procedures and likely to have been related to poor healing or infection. Over time, we have altered out technique, which has led to a reduction in exposures. We now perform full-thickness dissection of the vagina, including the fascia down to either the rectum or bladder with a mini-incision and two-layer closure. NICE guidance on SCP using mesh reported success rates of 93%, with erosion rates between 2% and 4%.³³ No major complications were reported in our standard repair group. There were no bladder or rectal injuries reported and no hematomas or blood transfusions required in either group. Interestingly in the Carey study, bladder or bowel injuries occurred in 5% of the standard repair group. In one randomized multicenter study involving 201 patients, there were no blood transfusions reported in the mesh group compared to 2.2% in the non-mesh group.⁵ We had no patients requiring a transfusion in either arm. Looking at other potential complications, in the NICE systematic review, there were no significant differences in infection rates between mesh (5%) and no mesh (4.8%).

Conclusion

In this study, vaginal surgery augmented by mesh resulted in a statistically significant improvement in symptoms of vaginal soreness and dragging pain. Though prolapse symptoms appeared to have greater improvement with mesh surgery, they did not attain statistical significance over standard treatment. It is reassuring that the standard procedure had a statistically significant improvement in symptoms from baseline in the majority of categories, and therefore remains a valid treatment option.

Experience in vaginal repair augmented by mesh has led us on a steep learning curve. Our operative procedure has been adapted over time, and so any randomized study that involves this procedure needs to take the learning curve of the operator into account and ensure they have reached a certain level of skill in performing the procedure.²⁴

Although this study is limited by small numbers and is not a randomized trial, it does demonstrate encouraging results with both mesh procedures and standard surgery.

Footnotes

Acknowledgments

We would like to thank the staff of gynecological outpatients and theaters of the University Hospital of North Staffordshire for their hard work and dedication.

Disclosure Statement

J. Cooper received sponsorship from various manufacturers of vaginal mesh to attend educational conferences and training courses, including on vaginal mesh. No competing financial interests exist for the other authors.

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