Effect of anterior vaginal wall prolapse repair by modified transvaginal mesh surgery: a retrospective cohort study

DOI: https://doi.org/10.21203/rs.3.rs-2263090/v1

Abstract

Objective To explore clinical outcomes and complications of modified Transvaginal mesh (M-TVM) for advanced anterior vaginal wall prolapse in 1 year follow up.

Methods 574 patients underwent TVM surgeries from 2019 to 2020 were collected and divided into traditional TVM group and M-TVM group according to different surgeries, all preoperative and postoperative data was obtained and compared between the two groups.

Results  285 women were involved eventually, including 181 for TVM group and 104 for M-TVM group. No significant differences of general conditions were found between these two groups. During long-term follow up period, patients in TVM group were more likely to suffer pelvic pain than M-TVM group after surgery (P=0.046). Meshes placed with M-TVM protocol (4.5±0.69 cm) seemed much wider than meshes placed with TVM (3.0±0.91cm). Surgeries can significantly change a prolapse to point Aa and Ba on POP-Q compared to preoperative data. M-TVM procedures may significant change point C and D after surgery compared to TVM surgery(P＜0.001).

Conclusion M-TVM is a commendable procedure that can significant correct anterior prolapse with mesh extended wider, and also supply stable apical support at the same time.

Summary

M-TVM is a commendable procedure that can significant correct anterior prolapse with mesh extended wider, and also supply stable apical support.

 

Introduction

Anterior vaginal wall prolapse is the most common type of pelvic organ prolapse (POP), which is regarded as a benign condition that occurs in 40–60% of women [1].The etiology of anterior vaginal wall prolapse were different. One early theory focused on attenuation and weakening of the underlying vaginal layers [2]. Another theory suggests that anterior wall defects generate due to a break in the connective tissue of the pelvic floor musculature to the fibrous thickening of the levator ani fascia or the white line [3]. More recently, it has been proposed that most anterior wall defects result from impairment of the pubovisceral portion of the levators and the apical vaginal suspension complex (namely the cardinal and uterosacral ligaments) [4]. These new theories may remind the surgeons that enhanced apical support at the same time of repairing anterior vaginal wall may be a newly strategy of improving efficiency of anterior vaginal wall prolapse repair surgeries.

Treatments of anterior vaginal wall prolapse are challenging. Anterior colporrhaphy used to be the most frequent approach for anterior vaginal wall prolapse repair, but with the high risk of recurrence rate [5]. Transvaginal mesh (TVM) surgery showed a great results of high cure rate and low recurrence [6]. However, the most controversial issue of TVM is complication [7]. Therefore, how to avoid or at least get maximum reducing of postoperative complications are the burning questions for urogynecology surgeons. Previous literature shows that postoperative mesh shrinkage is one common cause of pelvic pain, which is the most common complications after TVM [8]. VELEMIR reported recurrence after TVM repair is associated with severe mesh retraction [9]. Some believed mesh shrinkage is related to insufficient intraoperative spreading [10]. Improving the protocol of TVM and enhancing the efficiency of surgery may be the key points.

A modified TVM procedure was introduced to our center in 2019 for anterior vaginal wall prolapse repair to avoid postoperative mesh shrinkage and to get advanced apical support showed good outcomes. In this study, we retrospectively recruited the patients undergoing classical anterior pelvic floor repair (TVM) and modified TVM(M-TVM). Complications and outcomes were collected and compared to gain truly understanding of these two different surgeries for anterior prolapse.

Materials And Methods

Patient population

This was a retrospective, single-center based cohort study with 574 women who were underwent anterior pelvic floor repair surgeries between January 1, 2019 and October30, 2020. The inclusion criteria were as follows: (1) primary diagnosis of III or IV grade anterior vaginal wall prolapse; (2) complete data acquisition; (3) no other systemic diseases. Volunteers who met the following were excluded: (1) had other procedures during surgery, such as tension free vaginal tape (TVT) surgery, etc.; (2) company with stage III or IV apical or posterior vaginal wall prolapse; (3) had pelvic surgeries or hysterectomy before. 299 patients met the criteria and after checking complete follow-up data and signed informed consent, 285 participants were recruited finally. According to the different procedure, they were divided into 2 groups. Those are anterior pelvic floor repair (TVM) group(n = 181), and modified anterior pelvic floor repair(M-TVM) group(n = 104) (see Fig. 1).

Clinical Procedures

All enrolled patients had no absolute contraindications to these two surgical methods. After being fully informed of the relevant advantages and disadvantages of these two surgical methods by surgeons, patients chose the surgical procedures by themselves according to their own considerations.

For TVM, the procedure was performed with the patient in the lithotomy position under general anesthesia. A 0.5cm incision was made at the inner folds of both thighs at the horizontal level of the urethral orifice. Another 0.5cm incision was made 1cm laterally and 2cm below the former incision as the second puncture point. A puncture device was used to penetrate from the above puncture points, respectively near the inner corner of the obturator foramen and above the ischial spine. With this procedures, 4 arms of mesh were suspended to the bilateral obturator muscle and arcus tendineus fascia pelvis (see Fig. 2A)

M-TVM procedure the protocol was almost the same at the beginning until cutting the 4 incisions. A 0.5cm incision was made at the inner folds of both thighs at the horizontal level of the urethral orifice. Another 0.5cm incision was made 4cm laterally and 4cm below the former incision as the second puncture point.4 arms polypropylene mesh (TiLOOP total 4, pfm, Nṻrnberg, Germany) was penetrated from the first puncture point with a curved hook puncture device (same as above). Near the inner corner of the obturator, the upper limb band of the mesh was led out of the skin through the Vicryl 2/0, and the mesh head was fixed at the bottom of the urethral mouth with no. 4 silk wire. With deep puncture device via the puncture point to the pelvic cavity puncture, via anus levator and siatic rectal fossa, ischial spine on both sides of finger guided through the inside of the sacrospinous ligament, the lower two arms of mesh were hanging in the sacral spine ligament midpoint. (See Fig. 2B)

The POP-Q classification was used to evaluate level of POP according to the International Continence Society [11]. Examination of the women was performed in the dorsal lithotomy position. Following inspection of the vulva and perineum, the labia were separated and prolapse was noted. Women were asked to perform Valsalva maneuver (women were asked to pinch the nose, close the mouth, and exhale like as inflating the balloon, bear down for 10 to 15 seconds) for measurement of Aa, Ba, C, Ap, Bp, D, gh, pb, tvl.

3/4 dimensional transperineal ultrasound was performed 6 months after operation with 3 senior sonographers. Width and length of meshes were measured in vesicovaginal gap follow Dietz methods [12] (supplemental Fig. 1).

All patients came to out-patient department for postoperative examination at 3, 6, and 12 months after surgeries. Pelvic examinations were taken including symptom checklist, a stress test, POP-Q test and transperineal ultrasound.

Follow-up

Complications directly related to the surgeries were acquired by analyzing questionnaires that women taken at each visit when we follow up, which include pelvic floor function (PFDI20, PFIQ7), sexual function (PISQ-12), quality of life (EQ5D-3L main score and visual analogic scale (VAS), and improvement (PGII). Vaginal examinations were conducted to check for mesh erosion and assess vaginal support according to the POP-Q evaluation. To evaluate recurrence, we included a composite outcome defined by either anatomical recurrence (any point Ba, C, or Bp > 0 cm beyond the hymen), and/or retreatment (reintervention for prolapse recurrence).

Data Collection

All patient data were complete and collected from hospital medical records, which include general condition, detailed medical history, surgical characteristics, and all information concerning postoperative complications.

Statistical analysis

Sample size was calculated according to the formula as follows:


According to the literatures[5, 6],the expected population rate was 0.0288, we estimated σ = 5, \(\delta\)= 0.03, α = 0.05, then the sample size was at least 120. In consideration of 10% of lost to follow-up, the sample size would be 132.

Statistical analysis was performed after normality testing (Kolmogorov-Smirnov and Shapiro-Wilk testing). Continuous variables are expressed as means with SDs. For categorical variables, counts and percentages are presented. One-way ANOVA was used to compare normally distributed continuous, Kruskal-Wallis test was used in the event of abnormal distributions. Contingency tables with Chi-squared test were used to assess the relationship between quantitative variables. Statistical analyses were performed using SPSS 20.0 software for windows.

Ethics Approval

This retrospective study was approved by the ethical committee of Chongqing Health Center for Women and Children (Trial registration number: NO.(2021) EC (D) 036). Informed consents were obtained from all individual participants included in the study and Patients signed informed consent regarding publishing their data

Results

A total of 285 patients who signed inform consents were recruited eventually. All the surgeries were performed by 3 experienced surgeons, difference comparison of postoperative complications and recurrence rate among these surgeons were taken and showed there was no significant difference among them (see supplemental table 1).

Table 1 shows the general conditions of two groups. No significant differences were found between these two groups. It revealed that the objectives of our study were undifferentiated. About 98% patients recruited in this study were postmenopausal, and almost 80% patients were suffered stage III anterior vaginal wall prolapse, 55% were companied with stage I or II apical prolapse.

 
 
Table 1

general conditions of study groupsa

Characteristic

TVM group

(n = 181)

M-TVM group

(n = 104)

P value

Age

65.7 ± 6.57

64.9 ± 6.37

0.335

Gravidity

3.7 ± 1.10

3.9 ± 1.23

0.159

Parity

2.0 ± 0.91

2.1 ± 0.89

0.185

BMI( kg/m2)

26.56 ± 3.58

26.12 ± 3.30

0.312

Postmenopausal

178(98.3%)

102(98.1%)

0.601

POP

Stage III

145(80.1%)

85(81.7%)

0.433

Stage IV

36(19.9%)

19(18.3%)

0.433

Apical prolapsed (stage I or II )

101(55.8%)

57(54.8%)

0.484
avalues are given as mean ± standard deviation or as number (percentage)
TVM, anterior pelvic floor repair; M-TVM, modified anterior pelvic floor repair; BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); POP, Pelvic Organ Prolapse;

Table 2 shows surgical characteristics and complications during or after operation. Data during operation seemed no difference between these two groups except operative time. It seems M-TVM (43.6 ± 4.220 min) cost little much time than TVM group (42.1 ± 4.136 min). Complications related to surgery in the follow-up periods in Table 2 showed no significant difference between these two groups, which included mesh exposure (P = 0.601), infection(P = 0.464), de novo urinary stress incontinence (P = 0.457), bladder outlet obstruction(P = 0.365) and Dyspareunia (P = 0.610). In TVM group, patients were more likely to suffer pelvic pain than M-TVM group after surgery(P = 0.046).14 patients in TVM group and 3 patients in M-TVM group were found recurrence of POP after surgery (P = 0.076). Significant difference was found in width of mesh 6 months after surgeries between these two groups(3.0 ± 0.91 versus 4.5 ± 0.69) (P<0.001). Meshes placed with M-TVM protocol (4.5 ± 0.69 cm) seemed much wider than meshes placed with TVM (3.0 ± 0.91cm). No difference found in length of meshes (P = 0.721).

 
 
 
 
Table 2

characteristics related to surgeriesa.
 

TVM group

(n = 181)

M-TVM group

(n = 104)

P value

Surgical characteristics

Operative time, min

42.1 ± 4.136

43.6 ± 4.220

0.002

Estimated blood loss, ml

45 ± 6.3

46 ± 8.3

0.709

Hospital stays, d

1.8 ± 0.631

1.7 ± 0.75

0.691

Intraoperative injuries (bladder, hematoma, etc.)

4(2.2%)

3(2.9%)

0.503

Complications related to surgeries

Mesh exposure

3(1.7%)

2(1.9%)

0.601

Vaginal and pelvic pain

10(5.5%)

1(1.0%)

0.046

Infection

2(1.1%)

2(1.9%)

0.464

De novo urinary stress incontinence

24(13.3%)

15(14%)

0.457

Bladder outlet obstruction

0(0%)

1(1%)

0.365

dyspareunia

5(2.8%)

3(2.9%)

0.610

Outcome

Recurrence of POP

14(7.7%)

3(2.9%)

0.076

Width of mesh, cm

3.0 ± 0.91

4.5 ± 0.69

<0.001

Length of mesh, cm

3.2 ± 0.73

3.2 ± 0.69

0.721
a values are given as mean ± standard deviation or as number (percentage)
TVM, anterior pelvic floor repair; M-TVM, modified anterior pelvic floor repair; POP, Pelvic Organ Prolapse;

Table 3 revealed the preoperative and postoperative anatomical characteristics according to POP-Q classification. Surgeries can significantly change a prolapse to point Aa and Ba on POP-Q (P<0.05) and no difference was found between these two groups with point Aa and Ba no matter preoperatively or postoperatively. M-TVM procedures can significantly change point C and D after surgery compared to TVM surgery. Point C (-6.1 ± 0.60 cm) and point D (-8.1 ± 0.56) were much higher in M-TVM group than these two points in TVM group (-4.5 ± 1.8 cm, -6.5 ± 1.79 cm) 1 month after operation. So as they are in 3 months, 6 months and 1 year after surgeries.

 
 
 
 
Table 3

Preoperative and postoperative characteristics according to POP-Q classificationa

POP-Q measurements

TVM group

(n = 181)

M-TVM group

(n = 104)

P value

Preoperative data, cm

Aa

1.3 ± 0.51

1.4 ± 0.54

0.524

Ba

2.4 ± 0.83

2.4 ± 0.86

0.985

C

-4.2 ± 2.35

-4.6 ± 2.20

0.163

D

-6.2 ± 2.30

-6.6 ± 2.12

0.157

1 month after operation, cm

Aa

-2.7 ± 0.45

-2.8 ± 0.40

0.741

Ba

-2.7 ± 0.46

-2.8 ± 0.42

0.961

C

-4.5 ± 1.80

-6.1 ± 0.60

<0.001

D

-6.5 ± 1.79

-8.1 ± 0.56

<0.001

3 month after operation, cm b

Aa

-2.7 ± 0.45

-2.8 ± 0.37

0.439

Ba

-2.7 ± 0.44

-2.7 ± 0.45

0.845

C

-4.5 ± 1.79

-6.0 ± 0.60

<0.001

D

-6.5 ± 1.78

-8.0 ± 0.58

<0.001

6 month after operation, cmc

Aa

-2.7 ± 0.48

-2.7 ± 0.51

0.363

Ba

-2.7 ± 0.53

-2.7 ± 0.44

0.895

C

-4.4 ± 1.78

-6.0 ± 0.62

<0.001

D

-6.5 ± 1.76

-8.0 ± 0.57

<0.001

1 year after operation, cm

Aa

-2.7 ± 0.51

-2.7 ± 0.50

0.919

Ba

-2.7 ± 0.59

-2.7 ± 0.49

0.481

C

-4.4 ± 1.77

-5.9 ± 0.65

<0.001

D

-6.4 ± 1.76

-7.9 ± 0.58

<0.001
a values are given as mean ± standard deviation or as number (percentage)
b sample size of was changed in 3 months after operation as recurrence of POP(n = 3). TVM group (n = 179), M-TVM group (n = 103).
c sample size of was changed in 6 months after operation as recurrence of POP(n = 7). TVM group (n = 172), M-TVM group(n = 103).
dsample size of was changed in 1 year after operation as recurrence of POP(n = 7). TVM group (n = 167), M-TVM group (n = 101).
TVM, anterior pelvic floor repair; M-TVM, modified anterior pelvic floor repair; POP-Q, Pelvic Organ Prolapse quantification;

In order to compare the differences found in point C and D between these two procedures, we compared patients companied with I or II grade apical prolapse in these two groups, which were mild apical prolapse in TVM group(n = 96) and mild apical prolapse in M-TVM group(n = 55). General conditions were no difference. POP-Q data revealed that both of the two procedures could significant change point C and point D after surgery when patients companied with apical prolapse (P<0.05), but C and D were much higher in M-TVM group(P<0.001)(see Table 4).

 
 
 
 
Table 4

relative data of patients companied with or without I or II grade apical prolapse in modified anterior pelvic floor repair groupa
 

Mild apical prolapse in TVM group

(n = 96)b

mild apical prolapse in M-TVM group

(n = 55)c

P value

General conditions

Age

65.9 ± 6.50

64.4 ± 4.92

0.419

BMI( kg/m2)

26.7 ± 3.69

25.7 ± 3.51

0.108

Postmenopausal

95(99%)

55(100%)

0.636

Stage I apical prolapse

76(79.2%)

44(80%)

0.539

Stage II apical prolapse

20(20.8%)

11(20%)

0.539

POP-Q measurements, cm

C-PRE

-2.5 ± 1.73

-3.0 ± 1.70

0.067

C-1 MONd

-3.1 ± 0.88

-5.8 ± 0.40

<0.001

C-3 MON

-3.0 ± 0.83

-5.8 ± 0.43

<0.001

C-6 MON

-3.0 ± 0.78

-5.7 ± 0.45

<0.001

C-1 YEAR

-2.9 ± 0.77

-5.7 ± 0.47

<0.001

D-PRE

-4.6 ± 1.64

-5.1 ± 1.67

0.090

D-1 MONd

-5.1 ± 0.90

-7.9 ± 0.34

<0.001

D-3 MON

-5.1 ± 0.94

-7.8 ± 0.39

<0.001

D-6 MON

-5.0 ± 0.92

-7.8 ± 0.43

<0.001

D-1 YEAR

-5.0 ± 0.88

-7.7 ± 0.45

<0.001
a values are given as mean ± standard deviation or as number (percentage)
b 5 patients suffered from mild apical prolapse were excluded from TVM group because of recurrence with anterior vaginal wall prolapse when we follow up
c 2 patients suffered from mild apical prolapse were excluded from M-TVM group because of recurrence.
d P<0.05 when compare to preoperative data in the same group.
BMI, body mass index (calculated as weight in kilograms divided by height in meters squared); MON, month.

Discussion

In this study, we present a retrospective study on 285 patients undergoing TVM surgeries and have demonstrated the modified procedure turned out good 1 year follow-up outcome. Results of patients’ general conditions revealed that the objectives of our study were undifferentiated. In accordance with previous study [13, 14], patients suffered from III or IV prolapse were almost all postmenopausal women aged above 60 years old. Pelvic floor prolapses always affect two or more compartment [15, 16], even we excluded patients with severe apical prolapse, there still almost half of the recruited ones accompany with grade I or II apical prolapse.

Requiring of surgeries for POP repairing are increases recently [13]. TVM surgery showed good outcomes and low recurrence rate in long term follow up. Nevertheless, in April 2019, the US FDA banned the use of transvaginal mesh for prolapse with long-term follow up outcome in FDA research [17]. However, TVM surgery still has been approved in many countries in the world and many prospective and retrospective studies with a significant amount of follow-up confirm the TVM technique's efficacy and low morbidity [18–21]. In present research, TVM procedures, no matter TVM or M-TVM, are demonstrated being reliable with high cure rate (96.6%, 275/285) and few complications in long-term follow-up.

Nowadays, improving procedure to avoid complications makes surgery more reliable. Studies reported some complications such as recurrence, mesh exposure and pelvic pain, may associated with mesh shrinkage, which is defined as the mesh did not remain flat but folded up on itself, either during implantation or immediately after closure [22]. In H.P. Dietz opinion, surgical technique seems to play a role as fixation of mesh to underlying tissue results in a flatter, more even appearance[13].Sunilet al reported a cadaver model study and stimulate apical support after sacrocolpopexy, and found out increasing mesh width is associated with better vaginal apical support, less mesh elongation, and higher failure loads[23].In traditional TVM surgery, if the deep branch puncture is not in place or fixed insecurely, it is easy to cause the shift of the deep branch band, so that the mesh is wrinkled, and the recurrence of the upper part of the front wall of prolapse. In order to avoid mesh shrinkage and also considering the theory of apical support in anterior wall defect, we modified the anchoring points with same size and tailor of meshes, which turned out different widths and good apical support after surgeries. TVM and M-TVM both significantly change the point Aa and point Ba after surgery, and remain stable in the follow up period. In addition, implants in M-TVM group are wider and flatter to address paravaginal defects than those in TVM. This improvement is also confirmed by following-up results that decreasing in the proportion of vaginal and pelvic pain, which is consider to be one result of mesh shrinkage in literatures [8, 10, 13]. Predictably, M-TVM can also improve the point C and D. The latter regroup about patients with mild apical prolapse also proved it. These results can be explained by De Lancey theory, because the TVM procedure offered only the level II attachment support, but M-TVM procedure offered additional force for level I suspension. In the present study, comparing with classical procedure, M-TVM can reconstruct anterior compartment validly and significantly reinforce apical support by improving the cervix to normal position (upper level of ischial spine), which may result in more stable outcome of surgery and decrease the recurrence rate. Though there was no difference in the two groups in our study in 1 year follow up, a bit longer time of following up may get different results.

There are some similarities between M-TVM and The Surelift system, which reported as a surgical mesh kit and comprised a monofilament polypropylene mesh with 6 adjustable fixation points to correct anterior and apical prolapse [24]. The existing literature on the outcomes of Surelift remains extremely limited. But it obviously gets more damages and increase risks and time of surgery because 6 arms need 6 cut incisions. So we modified the procedure to the M-TVM with 4 arms, which remain the latter two arms suspended to sacrospinous ligament with tension-free and the former two arms cross through obturator.

Limitations of the present study were as follows: first, our study were that of a single-center, retrospective design, and duration of 1-year follow-up, which may not be sufficiently long to draw substantial conclusions. Second, the population in this study was Asian women, which may not present the other populations. Third, there still remain high prevalence of de novo USI after anterior pelvic floor repair, this is in accordance with literatures [25] and may be explained by the theory that occult USI always masked by severe POP.

Conclusion

In a word, M-TVM can significant correct anterior prolapse with mesh extended wider, and also supply stable apical support at the same time.

Declarations

Acknowledgments: None

Funding：

This work was supported by Grant number 81671441 (Lubin LIU) and 82171622(Lubin LIU) from national natural science foundation of China.

Conflict of interest statement

all authors declare there have no conflict of interest.

 

Authors’ Contribution

Pan HU:  Data collection, Data analysis, Manuscript writing

Li LEI:  Project development, Data collection

Ying WANG:  Project development

Jing Tang: Data collection

Lubin LIU:  Project development, Data analysis, Manuscript revising

 

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Supplementary Table 1

Supplementary Table 1 is not available with this version