Medires Publishers - Article

Abstract

Purpose: Uterosacral ligament suspension (USLS) intends to restore suspension of the vaginal apex to the sacrouterine ligaments and can be done by either laparoscopic (L-USLS) or vaginal (V-USLS) route. The aim of this study was to compare recurrence, reoperation rate, and symptoms of prolapse, incontinence and pain in women undergoing L-USLS or V-USLS.

Methods: Our prospective cohort study included 63 women. All patients were included during 2015-2019. Women were examined by Pelvic Organ Prolapse Quantification system (POP-Q) at baseline and at a follow-up after one to five years. VAS-score and validated questionnaires (POPDI-6, UDI-6) were used. Objective recurrence was defined as POP-Q stage ≥2 at follow-up and subjective recurrence as patient-reported symptomatic recurrence and/or the need for retreatment by vaginal pessary or new prolapse surgery.

Results: A total of 18 (58.1%) in the L-USLS group had POP-Q stage ≥2 at follow-up compared to 26 (81.3%) in the V-USLS group (p=0.045). The vaginal apex (POP-Q point C) was -5cm (-6-(-4.5)); median and (IQR) following L-USLS and -3.5cm (-5(-3)) following V-USLS (p=0.003). Total vaginal length was 7 cm (7-8) in the L-USLS group compared to 6 cm (6-7) in the V-USLS group (p<0.001). No difference was found in subjective recurrence, retreatment, POPDI-6, UDI-6 or VAS score.

Conclusions: L-USLS seems to be associated with better outcomes in relation to objective recurrence, vaginal length and vaginal apex, but had no impact on subjective recurrence.

Abbreviations

USLS: Uterosacral ligament suspension

V-USLS: Vaginal uterosacral ligament suspension

L-USLS: Laparoscopic uterosacral ligament suspension

POP-Q: Pelvic Organ Prolapse Quantification System

POPDI-6: Pelvic Organ Prolapse Distress Inventory 6

UDI-6: Urinary Distress Inventory 6

VAS: Visual Analogue Scale

Introduction

Vaginal vault prolapse is frequently observed following hysterectomy due to failure of the cardinal-uterosacral ligament complex causing the apex of the vagina to bulge into or outside the vagina. It is defined by the International Urogynecological Association (IUGA) and International Continence Society (ICS) as clinically evident descent of the apex of the vagina (vaginal vault or cuff scar after hysterectomy) [1]. Vaginal vault prolapse is associated with vaginal bulge or protrusion from the vaginal canal, urinary incontinence, difficulty urinating, bowel- and sexual dysfunction as well as pain, and thus often have a negative impact on women's quality of life [2, 3]. 

Surgical treatment options intend to restore suspension of the vaginal apex to the remnants of the cardinal-sacrouterine complex. Several surgical methods have previously been described including sacrocolpopexy, sacrospinous fixation and sacrouterine suspension [4,5]. Sacrocolpopexy using synthetic mesh has been considered the “gold standard” and has been shown to be superior to most other surgical procedures in relation to most outcomes, such as recurrence, sexual function and pain [6-7]. However, the presence of synthetic materials in the vagina has been demonstrated to be associated with complications such as erosions and dyspareunia in 0,4-5% [8-10]. The sacrospinous fixation is a vaginal approach where the vault is suspended to the sacrospinous ligament. This method has been associated with varying success rates of 67-99% [11, 12). Uterosacral ligament suspension (USLS) does not include synthetic materials and can be performed both as vaginal-, abdominal- and laparoscopic procedures [4,5]. The vaginal USLS (V-USLS) using native tissue was described by Shull et al when introduced [13] demonstrating effective operative results without the use of synthetic mesh. The vaginal approach is however complicated and consequently the laparoscopic USLS (L-USLS) for suspension of the uterosacral ligaments was introduced [14, 15]. Only few studies are available regarding comparison of the two methods. These studies are all retrospective with heterogeneous study population and study designs [16-21]. For this reason, further studies of high quality are needed to evaluate the efficacy of the two surgical methods in depth. Our aim was therefore to compare subjective and objective recurrence rates in women with vaginal vault prolapse undergoing L-USLS or V-USLS.

Materials And Methods

The study was performed as a single-center study. The study was designed as a prospective cohort study comparing L-USLS with V-USLS for vaginal vault prolapse repair. Inclusion criteria were women who underwent L-USLS or V-USLS for vaginal vault prolapse at Odense University Hospital and who were able to understand Danish. Women with previous genital cancer, previous radiation therapy in the pelvic area and women scheduled for sling procedures due to urinary incontinence were excluded. Women were classified as postmenopausal after one year without menstrual periods or if previous hysterectomy and ≥50 years of age.

Women undergoing L-USLS were included in the period 2015-2019 and women undergoing V-USLS during the period 2016-2018. The women were included prospectively after verbal and written informed consent, after being assured strict confidentiality and they were assured that non-participation would not influence the care received.

Demographic data for the women, data related to surgery, hospitalisation, and complications were recorded from their medical records. Women in the L-USLS group were included in the study before surgery and agreed to participate in a follow-up. Women in the V-USLS group were contacted after surgery and invited to a follow-up visit.

Follow-up included a clinical examination at the outpatient clinic and a questionnaire after 1-5 years. At all visits, women were examined by the same group of skilled urogynaecologists, to determine the degree of genital prolapse by Pelvic Organ Prolapse Quantification System (POP–Q) [22]. The women answered validated questionnaires Pelvic Organ Prolapse Distress Inventory 6 (POPDI-6) [23], Urinary Distress Inventory, Short Form (UDI-6) [24], and pain by Visual Analogue Scale (VAS) at follow-up. Subjective recurrence of prolapse was defined as patient-reported symptomatic recurrence and/or the need for retreatment by vaginal pessary or new prolapse surgery. Symptomatic recurrence was set at POPDI-6 score >17 at follow-up [25]. Objective recurrence was defined as POP-Q stage ≥2 at follow-up.

Surgical technique

Both procedures were performed by the same experienced group of four urogynaecologists. The vaginal procedure was performed in accordance with the description by Shull et al [13]. Briefly, it included the use of uterosacral ligament pedicles, pubocervical fascia, and rectovaginal fascia. For suspension of the uterosacral ligaments to the vaginal apex, two nonabsorbable Prolene (Ethicon®) 3-0 sutures were used on each side. After suspension of the vaginal apex to the uterosacral ligaments, the rectovaginal fascia was united with pubocervical fascia with absorbable Vicryl (Ethicon®) 2-0 sutures. The vaginal epithelium was closed with Vicryl (Ethicon®) 3-0 sutures.

The laparoscopic procedure included initial identification of the uterosacral remnant and both ureters. If not visible, dissection was performed to identify the ureter and their relationship to the uterosacral ligaments. The vaginal apex was identified using a vaginal probe and the bladder was dissected free from the apex. The cardinal ligaments were fixed with two Prolene (Ethicon®) 3-0 sutures on both vaginal sides including the rectovaginal fascia and adapted to the uterosacral ligaments, approximately at the level of the ischial spine, using extracorporeal suturing technique. The peritoneum was left without closure. Cystoscopy was performed after suture placement.

Statistics

We used descriptive statistics to evaluate the reproducibility of our sample and to assess exchangeability between the two groups. Categorical values were presented as frequency and percentage and non-categorical variables were presented as either mean and standard deviation or median and interquartile range (IQR) depending on whether the variables were normally distributed. For analysis between groups with categorical variables we used either chi-square test or Fischers exact test, depending on the fulfilment of Cochran’s rule. Non-categorical variables were evaluated by either Wilcoxon rank sum test or t-test, depending on whether the variable followed a normal distribution or not. Linear regression was used to evaluate the interaction between the surgical procedure and follow-up time. Since timing of the follow-up visit varied between participants, it was included as a continuous variable. We analysed VAS using a mixed effect model. However, due to the non-normality of the residuals and random effect, we used bootstrapping to acquire non-parametric confidence intervals of the treatment effect for the given timepoints and the likelihood ratio test. All p-values were two sided and considered statistically significant if they were less than 0.05. We used Hoechberg sequential procedure [26] to adjust for multiple testing.

Ethics statement

The study was registered in OPEN (Open Patient data Explorative Network). REDCap (Research Electronic Data Capture) was used for data collection and data management. The study was approved on August 26, 2020 by the Region of Southern Denmark, Journal number 20/37997. An additional application due to extension of the study was made and approved on November 17th, 2022 and on December 18th, 2023.

Results

A total of 78 women underwent USLS during the study period, 34 by L-USLS and 44 by V-USLS. In total 63 fulfilled the inclusion criteria and agreed to participate (31 L-USLS and 32 V-USLS).

In the L-USLS group three women were excluded, of which one refused to participate and two only completed parts of the follow-up questionnaires and examination. In the vaginal group 12 were excluded, two were not able to understand Danish and 10 refused to participate.

Follow-up for L-USLS was performed after 618 days (365-1819) (mean and range) and after 980 days (420-1538) for V-USLS.

Demographic parameters appear from Table 1. Only postmenopausal status differed between the two groups.

The duration of surgery was the same for L-USLS and V-USLS and no difference was observed in hospitalisation after surgery (table 2). Women undergoing V-USLS underwent more frequently an additional anterior or posterior colporrhaphy in the same procedure; 14 (43.8%) versus one (3.2%) in the L-USLS group. No difference was found in bladder perforation, urinary tract infection, wound infection, hematoma, incisional hernia, severe pain requiring hospitalisation or thromboembolism.  Lesion to the ureter or bleeding >500 ml was not seen in any of the groups.  Urinary retention did not occur in the L-USLS group but occurred in nine (28.1%) women in the V-USLS group (p=0.002). None of the women who experienced postoperative urinary retention had additional anterior colporrhaphy performed in the same procedure. In two patients undergoing V-USLS, the sutures were removed postoperatively due to pain or urinary retention (table 2).

POP-Q measurements and POP-Q stages did not differ between the two groups at inclusion. POP-Q measurements at follow-up were analysed by linear regression to take the inter-participant variation in time from surgery to follow-up into account (fig. 1). Women undergoing L-USLS had a longer total vaginal length (TVL) 7cm (7-8); median and (IQR) at follow-up compared to V-USLS 6cm (6-7); median and (IQR) in the vaginal group (p=<0.001). POP-Q point C, the vaginal apex, was -5cm (-6-(-4.5)) following L-USLS and -3.5cm (-5-3); median and (IQR) following V-USLS (p=0.003) at follow-up (fig. 1). Furthermore, women in the L-USLS group had less protrusion of the anterior wall of the vagina (Aa -2cm (-3-(-1)) compared to -0.5cm (-2-0), p=0.013 and Ba -2cm (-3-(-1)) compared to -0.5cm (-2-0); median and (IQR), p=0.017), but when taking multiple testing into account by Hoechberg sequential procedure the difference in Aa and Ba was not significant (fig. 1).

Subjective recurrence, defined as POPDI-6 score >17 and/or the need for retreatment, was observed in 12 (38,7%) of women undergoing L-USLS and 9 (28.1%) undergoing V-USLS (p=0.352). A total of 18 (58.1%) of women undergoing L-USLS had objective recurrence defined as POP-Q stage ≥2 at follow-up compared to 26 (81.3%) operated by V-USLS (p=0.045). More women in the V-USLS group had recurrence of prolapse in the anterior compartment 22 (68.5%) compared to the L-USLS group 9 (29.0%) (p=0.002) (table 3).

The follow-up disclosed no difference in pain (median VAS score), prolapse- (median POPDI-6 score) or incontinence symptoms (median UDI-6 score). No difference was observed in the need of vaginal pessary or need of new prolapse surgery in the two groups (table 4).

Figures and tables

Table 1: Descriptive data for the 63 participants

L-USLS, laparoscopic uterosacral ligament suspension; V-USLS, vaginal uterosacral ligament suspension; BMI, body mass index; HRT, hormone replacement therapy

* Independent Samples T-Test

** Mann-Whitney U-test

***Fisher’s exact test

****Chi-square test

Table 2: Data on surgery, hospitalization and complications

L-USLS, laparoscopic uterosacral ligament suspension; V-USLS, vaginal uterosacral ligament suspension; min, minutes; ml, millilitres

*Mann-Whitney U-test

**Fisher’s exact test

Table 3: Recurrence of prolapse after surgery at follow-upa

aFollow-up was done after 618 days (365-1819) for L-USLS and after 980 days (420-1538) for V-USLS.

bPOPDI-6 score >17 at follow up and/or need for retreatment

c POP-Q ≥stage 2 prolapse at follow up

* Chi-square test

** Fisher's exact test

Table 4: Comparison after surgery at follow-upa

aFollow-up was done after 618 days (365-1819) for L-USLS and after 980 days (420-1538) for V-USLS.

VAS, Visual analogue scale; POPDI-6, Pelvic Organ Prolapse Inventory 6; UDI-6, Urinary Distress Inventory 6

* Mann-Whitney U-test

** Fisher's exact test

Fig 1: POP-Q measurements at follow-up

Figure legend: POP-Q measurements at follow-up for laparoscopic uterosacral ligament suspension and vaginal uterosacral ligament suspension. Analysed by linear regression model with follow-up time as continuous variable. Presented as medians and interquartile range.

*p=0.013, **p=0.017, ***p=0.003, ****p=<0.001

Discussion

Our study found that the L-USLS was associated with better objective outcomes at follow-up regarding the vaginal apex (POP-Q point C) and vaginal length (POP-Q point TVL) compared to V-USLS. However, our study did not disclose any beneficial effect in subjective recurrence in respect to the symptoms recorded by the women or the need for reoperation or use of vaginal pessary. This is in accordance with the previous observation that POP-Q only weakly is associated with symptoms in relation to vaginal prolapse except the presence of bulging symptoms [27, 28]. It can be discussed whether better outcomes in POP-Q are important if the difference does not lead to women experiencing fewer symptoms. However, other factors such as sexual function may play a role, but this was not assessed in the present study.

Originally, vaginal sacrouterine suspension was described by Shull et al [13] demonstrating effective surgical results on apical prolapse and a low recurrence rate. Since then, several authors have described the laparoscopic method for suspension of the uterosacral ligaments [14, 15]. Only a few studies compare the efficacy of the laparoscopic procedure in relation to the vaginal approach [16-21]. Major problems with these studies are especially the small sample sizes and heterogeneity of the study designs and of the study populations. Furthermore, these previous studies were all retrospective often with short follow-up periods ≤1 year or without follow-up [16-21]. Most of these studies did not examine patient reported symptoms after surgery [16,18,20]. The heterogeneity of the studies complicates comparison of the results and makes transfer of the findings to clinical practice challenging. Further, all the above-mentioned studies define success rate differently which calls for the need to standardise the definition of recurrence of prolapse after prolapse surgery.

In a retrospective study, Haj-Yahya et al [16] compared uterus preserving laparoscopic uterosacral ligament hysteropexy with total vaginal hysterectomy and USLS. They reported improved outcomes for the laparoscopic procedure in relation to POP-Q point Ba, C and Bp comparable to what was observed in our results [16].

Another retrospective study [21] compared L-USLS and V-USLS including only a short-term follow-up (median follow-up time of 21.5 weeks), and only on prolapse recurrence by POP-Q. They observed similar recurrence rates for both methods, except total vaginal length, which was longer following L-USLS, similar to our results [21]. In a recent review, Meriwether et al [29] also reported an improved vaginal length following L-USLS compared to vaginal hysterectomy with USLS. As mentioned previously, this could be of importance especially for women who are sexually active.

The retrospective study by Houlihan et al [19] comparing L-USLS with V-USLS report recurrence rates based on patient-reported symptoms without clinical examination. They found patient-recorded symptomatic recurrence of prolapse higher in the vaginal group (41% vs 24%, p = 0.046) although retreatment did not differ between the groups. We think that patient reported outcomes are very important, but it can be problematic exclusively to rely on patient reported outcomes because of the possible discordance between physical examination findings and patient reported symptoms and due to risk of selection bias by non-responders. Furthermore, there is a lack of consensus on the definition of subjective recurrence. Our definition of subjective recurrence was based on Karjalainen et al. [25] who reported that postoperative scores on ≤ 17 for POPDI-6 signify acceptable symptom state after prolapse surgery.

Our study disclosed that 28.1% of the women experienced urinary retention in the vaginal group compared to none in the laparoscopic group. This is a serious complication leading to prolonged hospitalisation and repeated catheterisation of the bladder. In our study, women with continuous urinary retention were trained in self-catheterisations and were offered follow-up by telephone. Beside discomfort for the women, repeated catheterisation increases the risk of urinary tract infection [30]. We did not disclose any difference in urinary tract infection in the two groups, however, we were not able to record urinary tract infection if treated by a general practitioner. Our findings are in line with two previous studies demonstrating a high rate of postoperative urinary retention following vaginal repair [18, 19]. Contrary, Turner et al [21] observed a retention rate of 58.0% in the V-USLS group and 63.5% in the L-USLS group.

In our study concomitant anterior repair was done in 14 (43.8%) in the vaginal group and only in one (3.2%) in the laparoscopic group. However, since none of the women who experienced postoperative urinary retention had additional anterior colporrhaphy done in the same procedure, our study does not suggest that anterior colporrhaphy explains the increased risk of urinary retention seen in the vaginal group.

In our study, the duration of surgery was equal in the two groups in agreement with other studies [17, 19]. Turner et al [21] found a small increase in operative time for the laparoscopic group of 18 minutes. The deviating results may be related to the experience of the surgeons.

A limitation to our study was the design not being a randomised controlled trial. Therefore, we cannot exclude that our results were interfered by other factors than the different surgical procedures. Timing of the follow-up visit varied from 618 days (365-1819) after surgery in the L-USLS group to 980 days (420-1538) in the V-USLS group. Linear regression model with timing as a continuous variable was used to take this into account. However this may still have an impact on our results. We did not record the reason for offering either the laparoscopic or vaginal procedure, and we can thereby not exclude confounding by indication.

In the vaginal group 14 women had additional anterior or posterior colporrhaphy done compared to one in the laparoscopic group (table 2). Additional prolapse of anterior or posterior compartments are known to be risk factors for recurrence [31]. However, POP-Q at baseline did not differ between the groups and demographic data differed only in relation to postmenopausal status. It was not possible to take menopausal status into account in our regression analysis because unfortunately all women in the vaginal group were postmenopausal. Menopausal status was not identified as a significant risk factor for recurrence after prolapse surgery by two recent systematic reviews [31, 32], however it cannot be excluded that this influenced our results.

The fact that the study was not blinded could also have resulted in a bias in favour of one approach versus the other given the surgeon’s apriori preferences. Since several urogynaecologist were evaluating the patients, we think that this did not influence the results.

A higher number of women in the vaginal group refused to participate, 10 in the vaginal group compared to one in the laparoscopic group. We cannot exclude that the women would be less likely to participate if they were happy with the operative result, which would underestimate the positive effect in the vaginal group. An advantage of our study was the prospective design including a long-term follow-up on both POP-Q and symptoms recorded by validated questionnaires. Furthermore, all surgeons were skilled in both procedures.

Conclusion

Better outcomes in POP-Q score were observed in women who underwent laparoscopic uterosacral ligament suspension compared to vaginal uterosacral ligament suspension especially in relation to vaginal apex and vaginal length. These differences were not reflected in prolapse symptoms, incontinence, pain or the need for retreatment after surgery. Apparently, the two surgical approaches can be offered to women with vaginal vault prolapse according to the surgeon’s preference. However, randomised trials are needed to evaluate the efficacy of the two surgical methods in depth.

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