Abstract
Objectives:
Laparoscopic sacrocolpopexy (LSC), which is known for its low recurrence rate, is considered the gold standard for treating pelvic organ prolapse (POP). However, in some cases, prolapse recurrence occurs even after LSC, and its cause remains unclear. Thus, the current study aimed to investigate the factors correlated with POP that contribute to postoperative prolapse recurrence.
Materials and Methods:
The study enrolled 95 patients who underwent LSC at our hospital between June 2016 and December 2023. The Pearson’s Chi-square test, multiple logistic regression analysis, and Cox proportional hazards analysis were performed to determine the independent factors contributing to prolapse recurrence.
Results:
Based on the Pearson’s Chi-square test, age (≥74 or <74 years), pelvic organ prolapse staging system (4 or ≤3), and the presence of vesicovaginal adhesion were significantly correlated with prolapse recurrence (all P < 0.05). Among the preoperative and intraoperative factors, only the presence of vesicovaginal adhesion was a significant factor in the univariate and multivariate logistic regression analyses (P = 0.0034). In addition, only the presence of vesicovaginal adhesion was an independent factor of shorter time to prolapse recurrence in the multivariate Cox proportional hazards model (hazard ratio: 17.46, 95% confidence interval: 1.69–180.15, P = 0.0163).
Conclusion:
Vesicovaginal adhesion can be an independent factor of postoperative recurrence after LSC. In patients with POP undergoing LSC, particularly those with vesicovaginal adhesion, the anterior mesh may need to be fixed firmly.
Keywords: Laparoscopic sacrocolpopexy, pelvic organ prolapse, postoperative prolapse recurrence, vesicovaginal adhesion
INTRODUCTION
Pelvic organ prolapse (POP) affects 40%–50% of adult women, with 3%–6% experiencing pelvic pressure and vaginal bulge sensations.[1] Approximately 50% to <90% of patients receiving treatment for POP had symptoms such as urgency or frequency of urination, incontinence, and voiding dysfunction. Further, 31% and 57% of patients reported fecal incontinence and reduced sexual function, respectively.[2] Some conditions, such as incontinence, are correlated with higher rates of depression, social distancing, falls, and institutionalization in elderly individuals.[3] Conservative management, which involves pelvic floor physiotherapy, pessary use, and lifestyle changes (such as avoiding constipation and strenuous work), may be initiated in the primary care environment.[1] Suspensory and obliterative procedures and repairs are included in surgical therapies. However, there is a 6%–30% risk of recurrence after surgery.[1]
Several studies have revealed that compared with open and transvaginal techniques, laparoscopic sacrocolpopexy (LSC) has been considered beneficial since its introduction in 1994.[4,5,6] LSC has several advantages. For example, it is correlated with reduced recurrence rates, a lower incidence of dyspareunia, a shorter length of postoperative hospital stay, and a faster recovery period.[5,6] Moreover, LSC is precise and has a low recurrence rate and limited impact on sexual function after surgery. Thus, it has long been considered the gold standard for POP treatment, and robot-assisted sacrocolpopexy is now becoming the gold standard technique.[7]
LSC is known for its low recurrence rate. Nevertheless, this does not imply that patients who underwent LSC cannot present with POP recurrence.[8,9] One earlier study showed that age and the presence of diabetes mellitus are risk factors for POP recurrence, and another research revealed that failure to reinforce the posterior vaginal wall led to POP recurrence.[8,9] However, recurrence of anterior vaginal wall prolapse can be observed even after its reinforcement, and several recurrence patterns can be expected. Therefore, the current study aimed to investigate the causes of POP recurrence in patients who underwent LSC.
MATERIALS AND METHODS
Patients
The medical records of 95 patients who underwent LSC between June 2016 and December 2023 were retrospectively reviewed. The surgical indication was POP of stage ≥2 with symptoms such as a feeling of vaginal prolapse, or hydronephrosis and/or hydroureter caused by POP, even in asymptomatic cases.
All procedures performed in this study were in accordance with the tenets of the 2013 revision of the Declaration of Helsinki and the ethical standards of the National Defense Medical College (Saitama, Japan; ID, 4219). This study protocol was accepted on August 21, 2020, by the National Defense Medical College Ethics Committee. Written informed consents were collected from all patients. This study included patients who underwent LSC for POP within the above-mentioned timeframe and excluded those who declined to participate.
The median postoperative observation period was 12.3 months (interquartile range: 12.1–15.4). The median operative time calculated from all patients was 3.1 h (interquartile range: 2.6–4.3 h). Table 1 shows the clinical data such as age, body mass index (BMI), the POP staging system,[10] previous history of laparotomy procedures, blood loss volume, surgical duration, type of mesh used, type of surgical techniques used, intraoperative conditions, previous history of laparotomy, major intraoperative complications and prolapse type of POP.
Table 1.
Clinical characteristics of the patients
| LSC (n=95) | ||
|---|---|---|
| Age, median (IQR) | 74 (69−78) | |
| BMI (kg/m2), mean±SD | 22.6±2.4 | |
| POP-Q stage | Stage 2 | 6 |
| Stage 3 | 71 | |
| Stage 4 | 18 | |
| Previous laparotomy | Present | 4 |
| Absent | 91 | |
| Blood loss (mL), median (IQR) | 2 (0−6) | |
| Operative time (h), median (IQR) | 3.1 (2.6−4.3) | |
| Mesh used | ORIHIME | 65 |
| Polyform | 30 | |
| Mesh fixation to AVW | Staples | 53 |
| Suture | 42 | |
| Mesh fixation to PVW | Tackers | 68 |
| Suture | 27 | |
| Mesh fixation to the Cervix or VV | Tackers | 63 |
| Suture | 32 | |
| Abdominal cavity adhesion | Absent | 64 |
| Present | 31 | |
| Previous hysterectomy | Absent | 86 |
| Present | 9 | |
| Vesicovaginal adhesion | Absent | 84 |
| Present | 11 | |
| Intraoperative complications | Bladder injury | 4 |
| AVW injury | 7 | |
| Mode of recurrent POP | Cystocele | 5 |
LSC, laparoscopic sacrocolpopexy, IQR, interquartile range, SD, standard deviation, BMI, body mass index, POP-Q, pelvic organ prolapse quantification, AVW, anterior vaginal wall, PVW, posterior vaginal wall, VV, vaginal vault
Surgical methods
The LSC method basically followed the method described by Wattiez et al.[11] Briefly, after placing all ports, the patient was tilted 15° from horizontal in a Trendelenburg position, and the bowel was moved toward the head to secure a view of the pelvic cavity. The subsequent procedures included (1) dissection between the anterior vaginal wall and the bladder and fixation of the anterior wall mesh (Polyform™ [Boston Scientific Japan, Japan, Tokyo] or ORIHIME® [Kono Seisakusho, Japan, Tokyo]), (2) Subtotal hysterectomy and bilateral adnexectomy in the presence of the uterus and adnexa, (3) Dissection between the posterior vaginal wall and the rectum and fixation of the posterior wall mesh, (4) Mesh retroperitonealization and closure of the pelvic floor peritoneum, (5) Mesh fixation on the anterior longitudinal ligament, (6) Complete closure of the peritoneum.
Assessment methods of preoperative and postoperative parameters
Prolapse recurrence was defined as the most dependent portion being at POP stage ≥2, which means that the most distal prolapse portion is ≥−1 cm from the hymen plane, according to Takazawa et al.[12]
Statistical analysis
Pearson’s Chi-square test was conducted to evaluate the correlation between preoperative plus intraoperative factors and prolapse recurrence. The multiple logistic regression model and the Cox proportional hazards model were used to determine independent factors that contribute to prolapse recurrence. Statistical analysis was performed using JMP PRO version 17 (SAS Institute, Cary, NC, USA). A P < 0.05 was considered statistically significant.
RESULTS
Table 1 shows the patient background. Intraoperative bladder injury was observed in four patients and anterior vaginal wall injury in seven patients; however, there were no serious postoperative complications noted. All of them were rated as Clavien–Dindo classification grade 1.[13]
Based on the correlation analysis between pre- and intraoperative factors and prolapse recurrence, age (≥74 or <74 years), POP stage (4 or ≤3), and the presence of vesicovaginal adhesion were significantly correlated with prolapse recurrence (all P < 0.05) [Table 2].
Table 2.
Association between prolapse recurrence and pre- and intraoperative variables
| Prolapse recurrence | P | ||
|---|---|---|---|
|
| |||
| Present | Absent | ||
| Age | 0.0367 | ||
| ≥74 | 5 (9.6%) | 47 (90.4%) | |
| <74 | 0 (0%) | 43 (100%) | |
| BMI | 0.7346 | ||
| ≥22.6 | 3 (6.0%) | 47 (94.0%) | |
| <22.6 | 2 (4.4%) | 43 (95.6%) | |
| Diabetes mellitus | 0.6104 | ||
| Present | 1 (8.3%) | 11 (91.7%) | |
| Absent | 4 (4.8%) | 79 (95.2%) | |
| POP-Q | 0.0161 | ||
| Stage 4 | 3 (16.7%) | 15 (83.3%) | |
| Stage ≤3 | 2 (2.6%) | 75 (97.4%) | |
| Mesh used | 0.1186 | ||
| ORIHIMEÒ | 5 (7.7%) | 60 (92.3%) | |
| Polyform | 0 (0%) | 30 (100%) | |
| Mesh fixation to AVW | 0.4652 | ||
| Suture | 3 (7.1%) | 39 (92.9%) | |
| Staples | 2 (3.8%) | 51 (96.2%) | |
| Mesh fixation to PVW | 0.668 | ||
| Suture | 1 (3.7%) | 26 (96.3%) | |
| Tackers | 4 (5.9%) | 64 (94.1%) | |
| Mesh fixation to the Cervix or VV | 0.1016 | ||
| Suture | 0 (0%) | 32 (100%) | |
| Tackers | 5 (7.9%) | 58 (92.1%) | |
| Abdominal cavity adhesion | 0.7181 | ||
| Present | 2 (6.5%) | 29 (93.5%) | |
| Absent | 3 (4.7%) | 61 (95.3%) | |
| Previous hysterectomy | 0.4574 | ||
| Present | 0 (0%) | 9 (100%) | |
| Absent | 5 (5.8%) | 81 (94.2%) | |
| Vesicovaginal adhesion | <0.0001 | ||
| Present | 4 (36.4%) | 7 (63.6%) | |
| Absent | 1 (1.2%) | 83 (98.8%) | |
BMI, body mass index, POP-Q, pelvic organ prolapse quantification, AVW, anterior vaginal wall, PVW, posterior vaginal wall, VV, vaginal vault
Moreover, multiple logistic regression analysis was performed to detect independent factors contributing to prolapse recurrence among preoperative and intraoperative factors. Among various factors such as age, BMI, POP stage, mesh fixation to the anterior or posterior vaginal wall, abdominal cavity adhesion, and vesicovaginal adhesion, only the presence of vesicovaginal adhesion was a significant factor in both the univariate and multivariate analyses (P = 0.0034) [Table 3].
Table 3.
Factors contributing to postoperative prolapse recurrence
| Univariate | Multivariate | |||||||
|---|---|---|---|---|---|---|---|---|
|
|
|
|||||||
| OR | 95% CI | P | OR | 95% CI | P | |||
| BMI (kg/m2) (≥22.6 or <22.6) | 1.37 | 0.22 | 8.61 | 0.7355 | ||||
| POP-Q stage (4 or ≤3) | 7.50 | 1.15 | 48.81 | 0.0350 | 3.61 | 0.41 | 31.87 | 0.2486 |
| Mesh fixation to AVW (suture or staples) | 1.96 | 0.31 | 12.32 | 0.4723 | ||||
| Mesh fixation to PVW (suture or tackers) | 1.62 | 0.17 | 15.24 | 0.6707 | ||||
| Abdominal cavity adhesion (present or absent) | 1.40 | 0.22 | 8.86 | 0.7192 | ||||
| Vesicovaginal adhesion (present or absent) | 47.43 | 4.65 | 484.13 | 0.0011 | 35.01 | 3.23 | 379.15 | 0.0034 |
OR, odds ratio, CI, confidence interval, BMI, body mass index, POP-Q, pelvic organ prolapse quantification, AVW, anterior vaginal wall, PVW, posterior vaginal wall
Based on the univariate Cox proportional hazards model, patients with vesicovaginal adhesion had a shorter time to prolapse recurrence (P = 0.0066). Among these independent and close-to-independent factors in the univariate analysis, only the presence of vesicovaginal adhesion was an independent factor of shorter time to prolapse recurrence in the multivariate analysis (hazard ratio: 17.46, 95% confidence interval: 1.69–180.15, P = 0.0163) [Table 4].
Table 4.
Factors contributing to prolapse recurrence-free survival in Cox proportional hazard model
| Univariate | Multivariate | |||||||
|---|---|---|---|---|---|---|---|---|
|
|
|
|||||||
| HR | 95% CI | P | OR | 95% CI | P | |||
| BMI (kg/m2) (≥22.6 or <22 0.6) | 1.20 | 0.17 | 8.57 | 0.8539 | ||||
| POP-Q stage (4 or ≤3) | 5.63 | 0.88 | 35.90 | 0.0674 | 3.10 | 0.48 | 20.16 | 0.2355 |
| Mesh fixation to AVW (suture or staples) | 1.07 | 0.14 | 7.97 | 0.9468 | ||||
| Mesh fixation to PVW (suture or tackers) | 2.59 | 0.28 | 24.35 | 0.4040 | ||||
| Abdominal cavity adhesion (present or absent) | 1.64 | 0.17 | 15.84 | 0.6681 | ||||
| Vesicovaginal adhesion (present or absent) | 23.21 | 2.40 | 224.74 | 0.0066 | 17.46 | 1.69 | 180.15 | 0.0163 |
HR, hazard ratio, CI, confidence interval, BMI, body mass index, POP-Q, pelvic organ prolapse quantification, AVW, anterior vaginal wall, PVW, posterior vaginal wall
The Kaplan–Meier curves and the log-rank test results revealed significant differences in terms of the prolapse recurrence-free survival rates between patients with vesicovaginal adhesion and those without and between patients with stage 4 POP and those with stage ≤3 POP (P < 0.0001, P = 0.0450, respectively) [Figure 1a and b].
Figure 1.
The time to prolapse recurrence significantly differed between patients with and without vesicovaginal adhesion (VVA) (a) and between patients with stage 4 POP and those with stage ≤3 POP (b)
DISCUSSION
The presence of vesicovaginal adhesion was significantly correlated with prolapse recurrence, according to the correlation analysis. Further, based on the multiple logistic regression analysis and the Cox proportional hazards analysis, only the presence of vesicovaginal adhesion was an independent factor of prolapse recurrence. In fact, the mode of recurrence was cystocele in all cases of recurrence. Moreover, it is likely that the dense suture closure of the bladder or anterior vaginal wall with absorbable suture would have prevented the mesh exposure.
LSC has a lower rate of postoperative recurrence than other surgical techniques.[14] An earlier study revealed that the success rates of recurrence without reoperation did not significantly differ between the vaginal approach group (n = 110) and the LSC group (n = 54),[15] but another research showed that LSC was correlated with a greater satisfaction compared with transvaginal mesh surgery (TVM). Further, none of the selected patients presented with significant side effects postoperatively. The recurrence rates were 5.0% in the LSC group and 8.6% in the TVM group.[16] In this study, the incidence rate of postoperative prolapse recurrence was 5.2% (5/96), which was similar to that in the report of Wei et al.[16]
Both anterior and posterior wall prolapse can recur after LSC.[9,17] Cystocele and rectocele are the most common recurrence modes after LSC. However, the incidence of rectocele is low among patients with POP.[18] Thus, cystocele as the site of recurrence should be the focus.[9,17] The high recurrence rate of cystocele is most likely attributed to the disengagement of mesh fixation on the anterior vaginal wall. Some studies revealed that LSC required a higher operator skill level and longer surgical duration than other surgical methods.[8,19] An earlier research showed that the vesicovaginal space should be dissected vaginally during LSC to facilitate an easier and firmer mesh dissection and fixation.[20]
In addition to technical difficulties caused by the narrowness of the vesicovaginal space, challenges in dissecting the vesicovaginal space caused by firm adhesion are a factor of prolapse recurrence as cystocele after surgery. There are no studies on the causes of vesicovaginal adhesion. However, it can be attributed to repeated contact of the vaginal wall with underwear. In addition to studies about the causes of recurrence, earlier research revealed that intraoperative lysis of adhesions was among the independent factors of lower urinary tract injury.[21] Vesicovaginal adhesion is an intraoperative finding, and the degree of adhesion can only be predicted from the preoperative or intraoperative appearance of the anterior vaginal wall. In this study, 11 patients presented with intraoperative bladder or anterior vaginal wall injury because of vesicovaginal adhesion. Moreover, 4 of 11 patients had prolapse recurrence. In cases with strong adhesions between the bladder and anterior vaginal wall, it seemed obvious that the lack of a clear separation layer led to injury of the bladder or anterior vaginal wall. A significant correlation was found between prolapse recurrence and the occurrence of intraoperative injury.
Several studies have found higher recurrence rates after TVM using ORIHIME® compared to TVM using polypropylene mesh.[22,23] Prolapse recurrence was seen in 10 cases (33.3%) treated with TVM using ORIHIME® and three cases (9.1%) treated with TVM using polypropylene mesh at the 4-year follow-up.[23] It is anticipated that ORIHIME® mesh can present difficulties in maintaining its location because of its weaker tissue adhesion and less inflammatory reaction than polypropylene mesh.[23,24] In TVM, the mesh is fixed by penetrating the mesh arm through the sacrospinous ligament, while in LSC, the mesh is fixed by suture, and it is more likely that the recurrence after LSC was due to weak suture fixation instead of the nature of ORIHIME® mesh.
In the case of cystocele, the mesh sheets should be positioned on the anterior vaginal wall to reduce the operating time.[19] The so-called double meshes, which support the anterior and posterior vaginal walls, are frequently utilized, according to several studies.[25,26] Another method based on double meshes was reported after Nezhat et al. first reported double meshes.[4,27,28] In any case, as long as the suture fixation of the mesh is secure, the risk of recurrence is not considered to be much different for single or double meshes. Moreover, tighter fixation has not led to mesh infection or increased recurrence rates from our own institution’s experience to date, so there is no need to refrain from it.
If dissection of the vesicovaginal space becomes challenging, dissection to the area near the bladder neck will also be difficult. Moreover, the anterior mesh may have to be fixed cephalad of the bladder neck, which can lead to recurrence as cystocele. In addition, chronic inflammation of the anterior vaginal wall may have a negative effect on the mesh fixation site. However, this is a subject of future study. In any case, we must consider that dissection between the anterior vaginal wall and the bladder can lead to injury and/or prolapse recurrence in patients with firm vesicovaginal adhesion.
Among other preoperative and intraoperative factors, stage 4 POP was correlated with prolapse recurrence. Because of a greater tendency of protrusion even under normal circumstances, the pelvic organs of patients with stage 4 POP may be at higher risk of prolapse recurrence than those of patients with stage ≤3 POP. In patients undergoing LSC, a procedure in which a mesh is sutured to the cervix and the anterior longitudinal ligament covering the promontory was performed to prevent prolapse therefore even stage 4 POP may not be an independent factor of prolapse recurrence in the multivariate analysis. Unlike in this research, one study has shown that older age and the presence of diabetes were independent factors of prolapse recurrence.[9]
The current study had several limitations. First, this was a retrospective study conducted at a single center. Second, the patient population was relatively small. Third, the median follow-up period after surgery was comparatively short. To overcome these limitations, a more extensive, prospective investigation involving multiple centers should be conducted to strengthen data generalizability and offer more conclusive proof based on these findings. Further, subsequent research with a larger sample size must be performed to boost the robustness and statistical strength of the findings. Longer periods of monitoring may provide detailed information about the validity and long-term reliability of this study’s conclusions. Considering these limitations, LSC must be continually performed without causing recurrence in the future.
CONCLUSION
Vesicovaginal adhesion can be an independent factor of postoperative recurrence after LSC. In patients undergoing LSC who present with vesicovaginal adhesion, firm fixation must be achieved to ensure that the mesh does not slide off.
Author contributions
Data collection and analysis were performed by Kenji Kuroda, Koetsu Hamamoto, Kazuki Kawamura, Ayako Masunaga. Project development was developed by Akio Horiguchi and Keiichi Ito. The first draft of the manuscript was written by Kenji Kuroda and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.
Data availability statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.
Conflicts of interest
There are no conflicts of interest.
Funding Statement
Nil.
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Associated Data
This section collects any data citations, data availability statements, or supplementary materials included in this article.
Data Availability Statement
The datasets generated during and/or analyzed during the current study are available from the corresponding author on reasonable request.