The advantages and disadvantages of mesh-augmented pelvic organ prolapse repair are widely debated. There still remains, however, a dearth of information on the long-term outcomes and prospectively collected information on outcome measures such as symptom relief, recurrences, and complications largely derive from short-term evaluations. A recently updated Cochrane review on apical prolapse surgery concluded that use of mesh is not superior to native tissue repair with regard to recurrence rates.1 However, in most studies included in the systematic review, the number of patients was small, a variety of heterogeneous mesh products were pooled for analysis, and the follow-up time ranged from 1 to 3 years.1 Because some complications, such as mesh exposure, pain, and recurrences, may occur with a delay of onset,2 it is important to provide long-term data to fully understand the effects associated with any specific procedure over time. We have previously reported our short-term results on the Uphold Vaginal Support System for apical pelvic organ prolapse repair, showing satisfactory outcomes, which are in concordance with studies conducted by others.3–6 This study was undertaken to evaluate at 5 years postoperatively the subjective and objective outcomes.
MATERIALS AND METHODS
This is a prospective, multicenter, cohort study performed throughout 24 gynecological centers in Sweden, Finland, Denmark, and Norway. The study has been described in detail previously when short-term outcomes were reported.3,4 In summary, 207 patients with uterine or vaginal vault prolapse (apical prolapse, point C >−1), with or without vaginal anterior wall prolapse stage ≥2 (point Ba >−1), according to the Pelvic Organ Prolapse Quantification (POP-Q) system were included in the study from February to June 2012. All patients underwent surgery using the Uphold Lite Vaginal Support System,5 whereas anterior colporraphy was performed at the surgeons discretion. The mesh kit uses a small incision at the vaginal apex to introduce a Capio Suture Capturing Device to connect the monofilament, macroporous, polypropylene, lightweight mesh to the anterior part of the sacrospinosus ligaments and suspend the apex. Exclusion criteria included cervical elongation, previous or current pelvic organ cancer, severe rheumatic disease, insulin-treated diabetes mellitus, connective tissue disorder, and current systemic steroid treatment. No other clinically relevant pelvic organ disorder for which surgery was indicated was allowed to be present at the time of surgery including posterior vaginal wall prolapse, cervix elongation, or stress incontinence. The women were recontacted after 5 years for a follow-up visit. Twenty centers were able to assess a total of 164 women (81.2%) between January and March 2017. Reasons for nonparticipation included the following: inability to attend the visit within the window of follow-up (n = 21), unknown reason (n = 9), being deceased (n = 5, not related to the procedure), patient not capable or willing to participate (n = 4), inability to reach the patient (n = 3), and 1 patient suffering from terminal cancer (n = 1). The study was approved by the Stockholm Regional Board of Ethics at Karolinska Institutet, Stockholm, Sweden, and by the appropriate ethics committees of all participating clinics. The study was registered at www.clinicaltrials.gov: NCT01823055. The study protocol was vetted by the mesh manufacturing company before providing an investigator-initiated study grant, but the company had no further influence over execution of the study, analyses and interpretation of the data, or drafting the manuscript.
Vaginal topography and quantification of pelvic organ prolapse according to the POP-Q system were assessed before surgery and all subsequent visits, by the operating surgeon in most cases. Stage <2 of the apical compartment was considered as an optimal objective outcome. A vaginal inflammatory scale was used to assess erosion based on a grading from 0 to 4 (0, none; 1, mild; 2, moderate; 3, pronounced; 4, severe) of the following clinical parameters: granuloma, erosion, necrosis, infection, and rejection.7
Subjective outcomes were assessed by the Pelvic Floor Distress Inventory 20 (PFDI-20) and sexual satisfaction by the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).8,9 The PFDI-20 includes 20 questions and 3 scales (Urinary Distress Inventory-6, Pelvic Organ Prolapse Distress Inventory-6, and Colorectal-Anal Distress Inventory-8), which were analyzed both separately and in total score points. The subjective outcome was regarded optimal if the total score points after 5 years exceeded the preoperative score by at least 23 points, which is stated as a minimally important change.10,11 The PISQ consists of 12 questions, which measures the impact of pelvic organ prolapse on the patient's sexual life during the last 6 months. The questionnaire can be divided into 3 subscales: behavior-emotional, physical, and partner related. Higher points indicate better sexual satisfaction and the maximum score is 48. Pelvic pain was assessed using a visual analog scale (VAS) graded from 0 to 10.
Data on clinical characteristics are presented as frequencies (%). The difference in continuous variables between the groups was assessed by using the Mann-Whitney U test and categorical data by using the χ2 test. Comparison of data between the baseline, 1-year, and 5-year follow-up were calculated by 1-way repeated-measures analysis of variance. Comparison between 1- and 5-year outcomes were analyzed by using the Wilcoxon matched-paired signed-rank test. Possible risk factors for unsuccessful outcomes (POP-Q stage ≥2 at point C and <23-point difference between baseline and 5-year follow-up in the total PFDI-20 score points) were evaluated by a number of variables in a multivariate logistic regression analysis including previous hysterectomy, previous anterior colporraphy, age greater than 65 years, body mass index at least 25 kg/m2, multiparity (≥3 deliveries), and concomitant anterior vaginal wall repair. Results from the risk analysis are presented as odds ratios (ORs) with 95% confidence intervals (CIs). A P value less than 0.05 was considered significant for all analyses. All statistics were performed using IBM PASW Statistics, version 22. To assess the influence of patient dropouts, we performed a sensitivity analyses on preoperative and 1-year postoperative data.
A total of 207 women were operated on in the trial, after which 5 women withdrew from follow-up, leaving 202 women available for the 1-year assessment. A total of 164 (81.2%) of 202 women attended the 5-year follow-up visit. Complete and valid POP-Q data were available in 138 (84.1%) of 164 women and questionnaire data in 153 (93.3%) of 164 women. Of these 164 women, 71 (43.3%) had a history of previous anterior colporraphy and underwent the procedure because of apical-anterior recurrence. An isolated Uphold operation was performed in 110 women (67.1%), whereas concomitant anterior wall repair was done in 48 women (29.3%).
Patient characteristics are shown in Table 1. Most women reported 1 or more somatic diseases (n = 131; 79.9%), of which cardiovascular disease was the most common (n = 71; 43.3%). Half of the women reported a new somatic disease during follow-up. Between the 1- and 5-year visit, 33 women (21.6%) reported a gynecologist visit because of a procedure-related problem. The most common reason was urinary incontinence (7.2%), prolapse-related problem (6.5%), and pain (2.6%). Having the procedure as a primary or recurrent operation did not affect the number of extra visits, whereas additional visits for perceived procedure-related symptoms were more common among women having had an isolated Uphold operation (28.4%) as compared with the women having had an Uphold procedure with concomitant anterior colporraphy (7.8%, P = 0.01).
Between 1- and 5-year follow-up, a total of 19.7% of the women had had additional pelvic surgery and 9 women (5.5%) had had more than 1 additional operation/procedure: the most common were midurethral slings (n = 15), hysterectomy (n = 7), and posterior colporraphy (n = 6). A mesh removal procedure was performed in 3 women because of pain: immediately postoperatively in 2 women and between the 1- to 5-year follow-up in 1 woman. Reoperations were more common in women having had an isolated Uphold operation (23.6% vs 4.2%, P = 0.003) as well as in women with previous anterior colporraphy (24.7% vs 8.4%, P = 0.007).
Overall POP-Q stages and by compartment are shown in Table 2 and Figure 1. The apical outcome was optimal (POP-Q C/D stage 0 or 1) in 129 (93.5%) of 138 women. The difference between 1- and 5-year follow-up was not significant (P = 0.2). After excluding women having had a reoperation possibly affecting the apical compartment between visits (any prolapse operation or hysterectomy), the outcome was optimal in 115 women (83.3%). An optimal outcome was more common among women with a previous (94.8% vs 78.9%, P = 0.007) or concomitant (81.7% vs 96.9%, P = 0.04) anterior colporraphy. Anterior vaginal wall prolapse (Ba ≥ 0) was present in 31 women (22.4%) and posterior vaginal wall prolapse (Bp ≥ 0) in 35 women (25.4%) at 5-year follow-up. When assessing possible predictors for an optimal outcome, previous colporraphy was associated with increased odds for optimal outcome in the apical compartment (OR, 7.7; 95% CI, 1.4–42.6), whereas multiparity decreased the odds of an optimal apical outcome (OR, 0.2; 95% CI, 0.1–0.8). In sensitivity analyses, reoperations, POP-Q status, subjective outcome, or VAS did not differ between dropouts and participants.
At the 5-year visit, there were grade 1 granulomas noted in 2 patients, as well as 2 cases of erosion (1 grade 1 and 1 grade 2). Thus, the rate of erosion at 5 years was 1.4%. All of these were treated with local estrogen and none required a surgical intervention.
Subjective outcomes are presented in Table 3. All the domains of the PFDI-20 improved from the preoperative to the 5-year follow-up visit, but there were no significant differences in the scores between the 1- and 5-year visits. After 5 years, the total score points exceeded the baseline points in 89.4% of the women, whereas in 78.8% of the women, minimal clinically important difference (>23 points) was reached. Of the women, 86.8% reported no symptom, or symptom without any bother, to the question of bulge in vaginal area (PFDI-20 question number 3). The total rate of bother, however, increased from 1- to 5-year follow-up (9.5% vs 13.2%, P = 0.004). Any bother from urge incontinence (PFDI-20 question number 16) decreased between the 1- and 5-year follow-up visit (40.9% vs 35.4%, P < 0.001), whereas bother from stress incontinence increased (37.8% vs 42.1%, P < 0.001). The preoperative rates of bother from urge (55%) and stress (44%) incontinence both decreased after 5 years (P = 0.005 and P < 0.001, respectively). These findings were independent of previous or concomitant anterior colporraphy (data not shown).
The number of sexually active women decreased from baseline (n = 88) to the 1-year follow-up (n = 69) and additionally to 5-year follow-up (n = 55). However, at the 5-year visit, sexual satisfaction had improved in all domains compared with both baseline and 1 year in those sexually active (P < 0.001; Table 3). With regard to the specific question of dyspareunia (PISQ-12 question number 5), 63.6% reported never dyspareunia, whereas 14.5% reported seldom, 16.4% sometimes, 1.8% usually, and 3.6% always (36.4% in total as compared with 42.9% at 1 year and 59.2% at baseline).
The number of women with any pain (VAS >0) decreased from 1 to 5 years (65.8% vs 42.4%, P = 0.006). There was no significant difference in VAS scores between 1- and 5-year follow-up (mean ± SD, 0.4 ± 0.9 and 0.4 ± 1.2 respectively; P = 1.0), and both showed a significant decrease compared with baseline (1.0 ± 1.7; P < 0.001; Fig. 2). As mentioned previously, 3 women underwent mesh removal because of pain. In 3 women (2.0%), the VAS score for pain after 5 years was higher than 2 (1 woman with VAS 7 and 2 women with VAS 8). Detailed information on these women is presented in Table 4.
In our view, the main finding from this prospective 5-year follow-up study is that use of a suture capturing mesh device provides satisfactory and sustainable anatomical and subjective results in women with apical prolapse with or without concurrent anterior vaginal wall prolapse. However, mesh-related pain persevered in 2.0% of our patients and there was a relatively high rate of additional surgeries for pelvic organ dysfunction over time. In contrast, reoperations were not needed for mesh erosions. A rather high reoperation rate has been a concern in previous studies on pelvic organ prolapse repair using mesh and mesh kits.2,12–14 In our study, nearly 1 in 5 women underwent additional surgery between the 1- and 5-year visits, of which almost 1 in 3 patients had more than one procedure. Similar rates of reoperation have been reported in other studies using transvaginal mesh, but these studies have reported higher rates of mesh removal surgery. In one study using anterior mesh, the cumulative 5-year risk for additional surgery was 15.2%, of which the majority were mesh removals,13 whereas a study on apical prolapse had a 5.0% reoperation rate for any compartment recurrence and 5.1% for mesh removal/revision.12 Studies with midterm follow-up time has reported reoperation rates of between 8.9% and 18%15,16 and 24.2% up to 7 years after surgery.2 However, a direct comparison with these studies is difficult because the mesh types and surgical methods differ,12–14 vaginal compartments are not separated,2,13,14 and the number of concomitant procedures at the primary operation varies greatly. In our study, anterior repair was the only concomitant procedure allowed. For native tissue repair, the reoperation rate for the apical compartment is reported to be 11.6%.15
The anatomical outcomes were largely sustained at long term with only minor changes between the 1- and 5-year visits and significantly improved when compared with baseline. This indicates that with minimal amount of biomaterial a sufficient long-term support is provided. The result for the apical compartment (83.3%–93.5%) is also largely comparable to reported outcomes for procedures such as abdominal and laparoscopic colposuspension at mid to long term (76.5%–100%).17–19 These results are also comparable to results reported for large surface transvaginal mesh with successful outcomes in the range of 87% to 94.3% for the apical compartment.2,20–22 Having an optimal long-term apical outcome was associated with having had a previous anterior colporraphy, and it is possible that previously achieved anterior wall support together with suspension of the apex by the Uphold resulted in more sustainable long-term support, because level I and II supports together are regarded crucial for optimal result.15
We found that reoperations were more common among women having had an isolated Uphold procedure and/or in those having the procedure as a primary operation. It is possible that a concomitant or previous anterior colporraphy provides additional support for the urethra and bladder neck resulting in lower rates of postoperative stress incontinence, because 38.4% of the reoperations were midurethral slings. This supposition is supported by a study showing that an isolated anterior colporraphy reduces stress urinary incontinence in 27% of women with anterior vaginal wall prolapse and stress incontinence.23 Despite the relatively large number of women having had midurethral tape surgery at long-term follow-up, there was a slight increase in the stress urinary incontinence–specific question of the PFDI-20, suggesting that some patients may still require additional surgery. There was no similar trend for urgency urinary incontinence. Our results suggest that many women undergoing an Uphold procedure would benefit from a concurrent midurethral sling. However, this should be the focus of additional studies to show benefits and disadvantages of this approach given that concomitant procedures increase the risk for adverse events.24
At the 5-year follow-up, the pelvic organ prolapse distress domain remained significantly improved as compared with baseline and did not change significantly from 1 year postoperatively. This corresponds well with the anatomical outcomes and suggests that the procedure effectively provides organ prolapse symptom relief also at long term. All PISQ domains, behavioral-emotive, physical, and partner, improved after 5 years as compared with both to the baseline and 1 year. However, sexual activity was low in our study population and only 27% of patients could be evaluated at the 5-year follow-up. The mean age of the women in our study population was 70 years, which together with pelvic organ dysfunction and comorbidity to some extent explains the low sexual activity. We cannot rule out that there were women who became sexually inactive due to the operation, because the reason for sexual inactivity was not reported. Among those sexually active, dyspareunia rates were largely comparable between the 1- and 5-year assessment.
In the present study, overall pain decreased significantly from 1 to 5 years and was also significantly lower as compared with baseline. Although this may seem encouraging, there were 3 women with persistent severe pain after 5 years, with no sign of resolution. Known risk factors for vaginal mesh–associated pain include preoperative pain,25 fibromyalgia, early postoperative pain, and somatization.26 Some of these characteristics were present also among the women with chronic pain after surgery in our study and suggest that women with preoperative pain syndromes may be at particular risk for pain complications. Pain after vaginal mesh procedures may be related to either the surgical technique or the mesh itself.27 Injury at dissection, suturing of the mesh to inappropriate pelvic structures, and tension of the mesh after placement are some factors that may be involved in pain development after surgery.27 Thus, good knowledge of pelvic floor anatomy, appropriate hands-on training before adopting new techniques, careful selection of patients, and continuously performing a high volume of procedures are important for optimal results.27,28
To our knowledge, this is the longest prospective follow-up of the Uphold procedure. Strengths of our study include the long-term assessment, the relatively low loss to follow-up, exclusion of concurrent procedures that may be a cause for misclassification, the standardized surgical method and postoperative protocol, and use of validated instruments for outcomes measures. Furthermore, patients who did not participate in follow-up visits did not differ significantly in characteristics from those who did in sensitivity analyses, suggesting that our results were valid for the study population; that is, the internal validity was satisfactory. The most obvious limitation of the study is the lack of a control group, which would have contributed useful information when interpreting our results. That the operating surgeon evaluated patients in most cases introduced a source of potential classification bias. Similarly, selection of patients for the study was left to surgeons' discretion, and inclusion was subjective with regard to suitability for the study and the need for concurrent procedures. These study traits limit the generalizability of our findings.
In conclusion, both apical and subjective outcomes achieved at short term were sustained after 5 years in women operated on for apical compartment prolapse using a suture-capturing device attaching a small-sized mesh to anchor the vaginal apex. This indicates that the current trend of minimizing the biomaterial load depends on the development of surgical procedures that optimally use the tensile properties of the mesh without causing excessive harm at long term.
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Keywords:Copyright © 2019 Wolters Kluwer Health, Inc. All rights reserved.
pelvic organ prolapse; apical compartment; long-term follow-up; transvaginal mesh; quality of life; pain