International Urogynecology Journal

, Volume 17, Issue 5, pp 492–497 | Cite as

SIS graft for anterior vaginal wall prolapse repair—a case-controlled study

  • Charlotte Chaliha
  • Usman Khalid
  • Luciana Campagna
  • G. Alessandro Digesu
  • Bini Ajay
  • Vik Khullar
Original Article

Abstract

The purpose of this study was to assess the effect on quality of life and prolapse severity of traditional anterior repair compared to anterior repair with a small intestine submucosa (SIS) graft. This report was designed as a case-control study. The sample of this study consisted of 14 women who underwent traditional anterior repair and 14 women who underwent anterior repair with SIS graft (SG) at a London teaching hospital. All women were assessed preoperatively and at 6 and 24 months postoperatively using a validated prolapse quality of life questionnaire and pelvic organ quantification system (POP-Q). Quality-of-life outcomes included the following: (1) General health perception, (2) Prolapse impact, (3) Role limitations, (4) Physical limitations, (5) Social limitations, (6) Personal relationships, (7) Emotions, (8) Sleep/Energy, and (9) Severity measures. The pelvic organ quantification measurement measured nine specific points relating to the anterior and posterior wall of the vagina, vaginal apex, genital hiatus (GH) and perineal body (PB). At 6-month follow-up, the SG repair group showed significant improvement in all quality-of-life parameters measured. In comparison to traditional repair, it was significantly better in improving role limitations, physical limitations and emotions. Both operations significantly improved prolapse quality-of-life severity measures. SG repair improved all POP-Q measurements significantly, except total vaginal length (TVL), whereas traditional repair improved some measurements (AA, midline point of anterior vaginal wall 3 cm proximal to the external urethral meatus; BA, most distal dependant position of the anterior vaginal wall from the vaginal vault or anterior fornix to AA; C, most distal/dependant edge of cervix or vault; AP, point on midline posterior vaginal wall 3 cm proximal to hymenal ring; BP, most distal/dependant point on the posterior vaginal wall from vault or posterior fornix to AP) but not others (location of posterior fornix (D), TVL, GH and PB). At 2-year follow-up, there was no significant difference between the two groups in terms of quality-of-life outcomes or prolapse severity measurements. Surgery for vaginal prolapse results in marked improvement in quality of life and prolapse severity. The greater improvement seen initially in the SG anterior group was not seen at 2-year follow-up.

Keywords

Prolapse Cystocele Collagen SIS graft 

Introduction

Pelvic organ prolapse is a common health problem, and though severe morbidity is rare, it has marked effects on quality of life. Approximately 50% of parous women will have some degree of vaginal prolapse, and only 10–20% of these will seek medical help [1]. The lifetime risk for prolapse surgery has been estimated to be around 11%, and 30% will undergo re-operation for recurrent prolapse [2]. The commonest site for recurrent prolapse is the anterior compartment with failure rates as high as 40% [1, 2]. Surgical treatments to reduce the high rates of recurrence have involved the use of biomaterials and have been suggested to improve vaginal prolapse repair success rates by reinforcing the repair [3].

A wide variety of biological and synthetic grafts are now available—autologous, allograft, xenograft and synthetic prosthesis. The aim of these is to optimise surgical outcome with no compromise of sexual function and vaginal capacity.

Autologous grafts increase postoperative morbidity and increase the risk of incisional hernia. Synthetic prostheses were developed to overcome these problems and are classified according to type of material, pore size and whether they are monofilamentous or multifilament in nature [4]. These materials are long lasting, inert, non-toxic and lack antigenicity. All synthetic non-absorbable meshes carry an inherent risk of erosion related to their biomechanical properties, sepsis and tissue healing. A pore size of greater than 75 μm facilitates macrophage and leucocyte migration to reduce the infective risk. A pore size of less than 10 μm may allow the passage of bacteria but is too small to allow the passage of leucocytes and increases the risk of sepsis [5, 6]. Donor allograft and xenograft materials, including small intestine submucosa (SIS) graft, reduce the risk of erosion but have a potential risk of prion or viral transmission despite extensive preparation to avoid this and reduce antigenicity. The SIS graft (SG) is produced as acellular tissue devoid of cells, which eliminates the porcine cells potentially harbouring viruses so that they cannot be transplanted to humans. The rate of prion transmission is relatively low compared to other xenografts, as SG is derived from the bowel which has a lower infectivity risk than other body parts of infected animals such as the brain and spinal cord. Residual antigenicity may be responsible for a graft-vs-host type reaction and lead to autolysis and graft failure. The use of porcine small intestine submucosa (SIS) and bovine-derived xenografts have been popularised due to their ready availability and concerns about using human tissue. Processed SIS is a biocompatible, acellular collagen matrix. It is found between the mucosal and muscular layers of the small intestine. The submucosa provides strength to the intestinal wall and consists predominantly of collagen. The submucosa is also a reservoir for cytokines that guide the replacement and repair of intestinal epithelial cells. It acts as a natural extracellular matrix scaffold for host cell incorporation and tissue remodelling. SIS was first investigated as a vascular graft substitute in dogs in 1989 [7]. Since then, its use has expanded to include urinary bladder substitute, urethral grafts, Achilles tendon replacement, and abdominal and vaginal wall repair. Prevel et al. in 1995 [8] used the SIS to repair hernias in Sprague–Dawley rats and found porcine SIS prevented recurrences, and there were no intra-abdominal adhesions. Clarke et al. [9] reported a pilot study in dogs using the SG to repair full-thickness abdominal wall defects. There were no recurrences of hernias, and the SIS was completely replaced by host tissue within 4 months. SG has also been used to aid the healing of superficial wounds and chronic ulcers in humans [10]. The SG material is infiltrated and replaced by host tissue within 90–120 days after implantation [11]. The subsequent host tissue is biocompatible, strong and resistant to infection [12]. At present, there is limited data on its use for repair of anterior vaginal wall prolapse.

The purpose of this study was to assess and compare the prolapse quality of life and vaginal prolapse examination findings after traditional anterior repair and anterior repair with SG.

Patients and methods

During 2001–2003, 14 consecutive women who underwent traditional anterior repair were compared with 14 consecutive women who underwent SG anterior repair for vaginal prolapse. Patients were asked to complete a validated prolapse quality of life questionnaire (PQOL) [13] preoperatively and at 6 and 24 months postoperatively. This assessed the following domains: (1) General health perception, (2) Prolapse impact, (3) Role limitations, (4) Physical limitations, (5) Social limitations, (6) Personal relationships, (7) Emotions, (8) Sleep/Energy, and (9) Severity measures. All patients underwent a vaginal examination before and after surgery to assess the severity of the vaginal prolapse. This was quantified using the International Continence Society’s pelvic organ prolapse scoring system, (POP-Q) [14].

All patients were operated on under general anaesthesia by one surgeon (VK). For those undergoing the traditional anterior repair, the patient was placed in lithotomy and catheterised. Ten milliliters of 1% marcaine with 1:200,000 adrenaline was infiltrated into the anterior vaginal wall, and a midline incision was made from the vault. If the cervix was dependant, then a vaginal hysterectomy was performed at the same time. The vesical fascia and bladder were reflected off the vaginal skin, and then lateral transverse support sutures (O Vicryl) were placed at the junction of the anterior wall of the vagina and fascial edge. The skin was then trimmed, closed with a continuous 2/0 Vicryl suture.

The SG insertion used the traditional anterior repair dissection; however, after placement of the transverse Vicryl sutures, the fascia was dissected further laterally extending under the subpubic arch to the pelvic side wall. The four-layer SG was pre-soaked for 5 min in a saline solution, then folded to produce a double thickness, and then cut into an octagonal shape which fitted well while being placed under tension over the anterior wall fascia. The SG was fixed using 6 3/0 PDS placed circumferentially around the graft to the anterior wall fascia. The sutures were only tied once all were in place to ensure even tension. The vaginal skin was trimmed and closed as with the traditional anterior repair.

All patients returned to the ward with a vaginal pack and foley catheter that was removed the next day.

To estimate the quality of life according to PQOL questionnaire before and after surgery, the mean values were used in the above parameters. The preoperative assessments were carried out by one investigator (AD). The postoperative follow-ups were performed by two investigators blinded to the groups (CC and LC). All questionnaires were self-completed.

The results for both groups were compared using Wilcoxon signed rank test. The preoperative scores for both operations were first compared statistically using the Mann–Whitney U test to determine that there were no intergroup significant differences preoperatively. This then enabled us to use the Mann–Whitney U test again to assess the difference between the two operations postoperatively.

Results

In the group of 14 women who had a traditional anterior repair, 2 had a previous anterior vaginal wall repair, and of the 14 women with SG insertion, 2 had a previous anterior repair. The mean age of those in the traditional repair group was 60 years (range 47–79 years) and in the SG group, 70 years (range 51–86 years). This was not significantly different.

There were no significant differences in quality of life preoperatively between the two groups, apart from role limitations which were significantly worse in the women undergoing the SG anterior repair.

In the traditional repair group, 10 out of 14 (71%) women had symptoms of urgency, frequency and nocturia, 4 out of 14 (29%) women had stress incontinence, and 5 out of 14 (36%) women had voiding symptoms preoperatively. Postoperatively, 7 out of 14 (50%) women had symptoms of urgency, frequency and nocturia, 2 out of 14 (14%) women had stress incontinence, and 3 out of 14 (21%) had voiding symptoms.

In SG group, 10 out of 14 (71%) women had symptoms of urgency, frequency and nocturia, none had stress incontinence, and 5 out of 14 (36%) women had voiding symptoms preoperatively. Postoperatively, 6 out of 14 (43%) women had symptoms of urgency, frequency and nocturia, none had stress incontinence, and 2 out of 14 (14%) women had voiding symptoms.

All women had urodynamics prior to surgery. Detrusor overactivity was noted in 8 of the traditional repair group and 7 of the SG group, and anticholinergics were commenced to treat their bladder symptoms. No woman had preoperative urodynamic stress incontinence or voiding abnormalities. Therefore, no concomitant continence procedures were required at the time of the prolapse repair.

At operation, there were no significant complications such as excessive bleeding. There were no significant postoperative complications such as bleeding, or voiding difficulties, and the average length of stay was 4 days (range 3–7 days). All patients were discharged within 7 days and had no significant complications or voiding difficulties. None of the SG group reported infections or had an erosion of the mesh.

At 6-month follow-up, both groups had significantly improved quality of life as shown by the large score differences for the different domains (Table 1). The SG anterior repair group showed significant improvement in all the parameters measured, but in comparison, the traditional repair group only had significantly better scores in improving role limitations, physical limitations and emotions. At 2-year follow-up, although both groups showed continuing improvements in quality of life, there were no significant differences between groups.(Table 2). In both groups, 10 out of 14 (71%) patients felt that they were cured and had no further prolapse symptoms.
Table 1

Preoperative and 6-month postoperative scores of women undergoing traditional anterior repair and small intestine submucosa (SIS) graft anterior repair

 

Traditional anterior repair

SIS graft repair

Traditional anterior repair

SIS graft repair

 

Preop mean score

Postop mean score

p value

Preop mean score

Postop mean score

p value

Mean difference in score

p value

General health perception

41

34

0.417

32

16

0.045*

−7

−16

0.376

Prolapse impact

62

14

0.004*

81

5

0.001*

−48

−76

0.050

Role limitations

35

17

0.043*

65

4

0.003*

−19

−62

0.007**

Physical limitations

38

14

0.040*

58

5

0.001*

−24

−54

0.024**

Social limitations

20

9

0.074

36

3

0.018*

−11

−26

0.202

Personal relationships

52

4

0.017*

65

7

0.027*

−55

−57

0.805

Emotions

42

13

0.009*

64

5

0.002*

−27

−61

0.019**

Sleep/Energy

36

23

0.162

58

17

0.005*

−14

−39

0.068

Severity measures

36

11

0.006*

42

5

0.005*

−24

−36

0.392

Preop preoperative, Postop postoperative

*p<0.05 (using Wilcoxon signed rank test)

**p<0.05 (using Mann–Whitney U test)

Table 2

Preoperative and 2-year postoperative P-QOL scores of women undergoing traditional anterior repair and SIS graft anterior repair

 

Traditional anterior repair

SIS graft repair

Traditional anterior repair

SIS graft repair

 

Preop mean score

Postop mean score

p value

Preop mean score

Postop mean score

p value

Mean difference in score

p value

General health perception

41

36

0.558

32

20

0.272

−5

−13

0.874

Prolapse impact

62

14

0.001*

81

14

0.001*

−48

−67

0.137

Role limitations

35

8

0.003*

65

10

0.002*

−26

−56

0.094

Physical limitations

38

1

0.002*

58

1

0.001*

−37

−57

0.077

Social limitations

20

2

0.005*

36

−2

0.007*

−18

−34

0.246

Personal relationships

52

0

0.189

65

−1

0.082

−15

−25

0.603

Emotions

42

−1

0.001*

64

10

0.003*

−39

−55

0.227

Sleep/energy

36

5

0.004*

58

15

0.003*

−31

−43

0.571

Severity measures

36

3

0.010*

42

`4

0.002*

−28

−38

0.541

*p<0.05 (using Wilcoxon signed rank test)

There was no significant difference preoperatively in POP-Q measurements between the two groups, although the measurement C (descent of cervix through vagina) was significantly worse in the women undergoing the traditional anterior repair.

At 6 months, both operations significantly improved POP-Q measurements. SG repair improved all POP-Q measurements significantly except total vaginal length (TVL) from pre- to postoperatively. In the traditional anterior repair group, some measurements significantly improved (AA, BA, C, AP and BP), but did not improve others (D, TVL, GH and PB). Comparison between groups did not reveal any significant differences (Table 3). At 2-year follow-up, the same effect was seen (Table 4).
Table 3

Preoperative and 6-month postoperative POP-Q scores of women undergoing traditional anterior repair and SIS graft anterior repair

 

Traditional anterior repair

SIS graft repair

Traditional anterior repair

SIS graft repair

 

Preop mean score

Postop mean score

p value

Preop mean score

Postop mean score

p value

Mean difference in score (preop−postop)

p value

AA

1.61

−1.32

0.002*

1.14

−2.07

0.001*

2.93

3.21

0.910

BA

2.25

−1.14

0.002*

1.64

−2.07

0.001*

3.39

3.71

0.734

C

1.71

−3.93

0.033*

−2.93

−5.57

0.008*

5.64

2.64

0.194

AP

0.21

−2.32

0.003*

−0.64

−2.82

0.001*

2.54

2.18

0.982

BP

1.14

−1.82

0.005*

−0.04

−2.82

0.001*

2.96

2.86

0.667

D

0.32

−0.14

0.655

−3.64

−0.43

 

0.46

 

0.432

TVL

4.29

6.57

0.162

6.93

5.57

0.084

−2.29

1.36

0.011**

GH

1.46

3.29

0.656

4.18

2.86

0.002*

−1.82

1.32

0.150

PB

3.21

3.64

0.373

3.14

4.07

0.004*

−0.43

−0.93

0.069

AA, BA, C, AP, BP, D = all reference points used to quantify prolapse as defined by [14]

TVL total vaginal length, GH genital hiatus, PB perineal body

*p<0.05 (using Wilcoxon signed rank test)

**p<0.05 (using Mann–Whitney U test)

Table 4

Preoperative and 2-year postoperative POP-Q scores of women undergoing traditional anterior repair and SIS graft anterior repair

 

Traditional anterior repair

SIS graft repair

Traditional anterior repair

SIS graft repair

 

Preop mean score

Postop mean score

p value

Preop mean score

Postop mean score

p value

Mean difference in score

p value

 

AA

1.61

−0.75

0.007*

1.14

−1.04

0.003*

−2.36

−2.18

0.482

BA

2.25

−0.61

0.007*

1.64

−1.07

0.004*

−2.86

−2.71

0.839

C

1.71

−5.21

0.008*

−2.93

−4.86

0.065

−6.93

−1.93

0.005**

AP

0.21

−1.86

0.019*

−0.64

−2.54

0.003*

−2.07

−1.89

1.000

BP

1.14

−1.79

0.024*

−0.04

−2.46

0.002*

−2.93

−2.5

0.839

D

0.32

0

 

−3.64

−0.43

 

−0.32

3.2

0.025**

TVL

4.29

6.68

0.065

6.93

5.36

0.217

2.39

−1.56

0.011**

GH

1.46

3.04

0.656

4.18

2.57

0.004*

1.57

−1.61

0.062

PB

3.21

3.21

0.398

3.14

3.57

0.063

0

0.43

0.454

*p<0.05 (using Wilcoxon signed rank test)

**p<0.05 (using Mann–Whitney U test)

Discussion

The surgical management of anterior vaginal wall prolapse is problematic, and mesh reinforcement has been advocated to reduce recurrence rates. This study has shown that surgery for anterior vaginal wall prolapse, both traditional repair and repair with graft reinforcement, results in prolapse quality of life and POP-Q vaginal measurement improvement at 6 and 24 months postoperatively. This emphasises the often hidden morbidity in various domains of quality of life that women with prolapse suffer.

There is little data on the use of SIS for anterior wall prolapse repair. In a small study of 18 women undergoing either a posterior or anterior repair, a success rate of 85% was reported at mean follow-up of 14.5 months [15]. Of the recurrences, there were 2 in the 10 women having an anterior repair but none in the posterior repair group.

At initial follow-up of 6 months, the SG had a significantly greater impact on prolapse quality of life compared to the traditional anterior repair group, with improvement in many parameters and no major complications and side-effects of use. However, at 2-year follow-up, although both groups showed improvement in prolapse quality of life, there was no greater improvement in those who had had SG.

POP-Q scores showed an improvement in prolapse severity in both groups, in particular Aa and Ba measurements of the anterior vaginal wall, which are most relevant for evaluation of the anterior vaginal wall. This was also seen at 24 months; however, there was no difference in POP-Q scores of the anterior vaginal wall between groups.

The lack of long-term benefit of use of SG could be due to small numbers in this study, such that the power of the study was reduced and differences were not detected. However, quality-of-life differences were seen at 6 months but not later than that, suggesting that the improvement if present at 2 years was not as substantial as at 6 months, and that SG benefits may not persist with time. This may be for several reasons. Firstly, there is some evidence that women with pelvic organ prolapse have defective collagen and less total collagen in their pubocervical fascia than controls. This collagen is weaker than that in controls with normal support. [16, 17, 18]. The SG acts as a matrix for new collagen formation, and this stimulates fibroblasts which may form inherently weaker host collagen. Although the SG promotes tissue growth, this may not be stronger than the original tissue if this is weak. This problem in host tissue quality may have produced the lack of significant differences between POP-Q scores of the anterior vaginal wall at 2 years. Also, net collagen formation from the SG placement will only occur if synthesis is stimulated faster than degradation. Increased collagen degradation resulting in a reduction in both total collagen content and collagen solubility and an increase in collagen turnover has been shown in the vaginal epithelial tissue of women with prolapse compared to controls [16].

The lack of benefit of SG repair over traditional repair at 24 months highlights the fact that the evaluation of any new procedure requires at least this length of follow-up. This also questions the utilisation and cost–benefit of SG use for anterior vaginal wall prolapse.

A larger longer-term study with patients randomised to SG or traditional repair with both subjective and objective evaluation is required to fully evaluate the use of SG for anterior vaginal wall prolapse repair.

Conclusion

Surgery for vaginal prolapse results in marked improvement in prolapse quality of life. The SG anterior repair has been shown to produce a greater improvement in quality of life than the traditional anterior repair in the short term, but there were no differences at 2-year follow-up.

References

  1. 1.
    Beck RP (1983) Pelvic relaxation prolapse. In: Kase NG, Weingold AB (eds) Principles and practice of clinical gynecology. Wiley, New York, pp 677–685Google Scholar
  2. 2.
    Olsen AL, Smith VJ, Bergstrom JO, Colling JC, Clark AL (1997) Epidemiology of surgically managed pelvic organ prolapsed and urinary incontinence. Obstet Gynecol 89:501–506CrossRefPubMedGoogle Scholar
  3. 3.
    Julian TM (1996) The efficacy of marlex mesh in the repair of severe, recurrent vaginal prolapse of the anterior midvaginal wall. Am J Obstet Gynecol 175:1472–1475CrossRefPubMedGoogle Scholar
  4. 4.
    Amid PK, Lichenstein IL (1997) Current assessment of Lichenstein tension-free hernia repair. Chirurg 68:959–964 (in German)CrossRefPubMedGoogle Scholar
  5. 5.
    Chiu CC, Welch L (1985) Characterisation of morphological and mechanical properties of surgical mesh fabrics. J Biomed Mater Res 19:903–916CrossRefPubMedGoogle Scholar
  6. 6.
    Brun JL, Bordenave L, Lefebrve F et al. (1992) Physical and biological characteristics of the main biomaterials used in pelvic surgery. Biomed Mater Eng 2:203–225PubMedGoogle Scholar
  7. 7.
    Badylak SF, Lantz G, Coffey A, Geddes LA (1989) Small intestinal submucosa as a large diameter vascular graft in the dog. J Surg Res 47:74–80CrossRefPubMedGoogle Scholar
  8. 8.
    Prevel CD, Eppley BL, Summerlin DJ, Jackson JR, McCarty M, Badylak SF (1995) Small intestinal submcosa: utilisation for repair of rodent abdominal wall defects. Ann Plast Surg 35:374–380PubMedCrossRefGoogle Scholar
  9. 9.
    Clarke KM, Lantz GC, Salisbury SK, Badylak SF, Hiles MC, Voytik SL (1996) Intestinal submucosa and polypropylene mesh for abdominal repair in dogs. J Surg Res 60:107–114CrossRefPubMedGoogle Scholar
  10. 10.
    Parmamenter MD (2000) Healing of patients with chronic or severe diabetic wounds using an ECM-based dressing. Proc Third SIS Symposium, Orlando, FL, November 2000Google Scholar
  11. 11.
    Badylak SF (1993) Small intestine submucosa (SIS): a biometric conducive to smart tissue remodelling. In: Bell E (ed) Tissue engineering: current perspectives. Burkhauser Publishers, Cambridge, MA, pp 179–189Google Scholar
  12. 12.
    Clemens JQ, Delancey JO, Faerber GJ et al. (2000) Urinary tract erosions after synthetic pubovaginal slings; diagnosis and management strategy. Urology 56:589–595CrossRefPubMedGoogle Scholar
  13. 13.
    Digesu GA, Khullar V, Cardozo L, Robinson D, Salvatore S (2005) P-QOL: a validated questionnaire to assess the symptoms and quality of life of women with urogenital prolapse. Int Urogynecol J Pelvic Floor Dysfunct 16(3):176–181CrossRefPubMedGoogle Scholar
  14. 14.
    Bump R, Mattiason A, Bo K et al (1996) The standardisation of terminology of female pelvic organ prolapse and pelvic floor dysfunction. Am J Obstet Gynecol 175:10–17CrossRefPubMedGoogle Scholar
  15. 15.
    Laborda E, Monga A (2003) The safety and efficacy of SIS mesh in women with recurrent prolapse. Int Urogynecol J 14(Suppl 1):S1–S81 [Abstract 100(426)]CrossRefGoogle Scholar
  16. 16.
    Jackson SR, Avery NC, Tarlton JF et al (1996) Changes in metabolism of collagen in genitourinary prolapse. Lancet 347:1658–1661CrossRefPubMedGoogle Scholar
  17. 17.
    Makinen J, Soderstrom KO, Kiilhoma P, Hirvonen T (1986) Histological changes in the vaginal connective tissue of patients with and without uterine prolapse. Arch Gynecol 239:17–20CrossRefPubMedGoogle Scholar
  18. 18.
    Norton P, Boyd C, Deak S (1992) Collagen synthesis in women with genital prolapse or stress urinary incontinence. Neurourol Urodyn 11:300–301Google Scholar

Copyright information

© International Urogynecology Journal 2006

Authors and Affiliations

  • Charlotte Chaliha
    • 1
  • Usman Khalid
    • 1
  • Luciana Campagna
    • 1
  • G. Alessandro Digesu
    • 2
  • Bini Ajay
    • 1
  • Vik Khullar
    • 1
  1. 1.Urogynaecology Unit, Academic Department of Obstetrics and Gynaecology, Imperial CollegeSt. Mary’s HospitalLondonUK
  2. 2.Department of Obstetrics and Gynaecology IIPoliclinico HospitalBariItaly

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