Withagen, Mariëlla I. MD; Vierhout, Mark E. MD, PhD; Hendriks, Jan C. PhD; Kluivers, Kirsten B. MD, PhD; Milani, Alfredo L. MD
Pelvic organ prolapse is a major health problem that ultimately affects up to 50% of parous women.1 A cross-sectional Dutch study2 demonstrated a prevalence of symptomatic pelvic organ prolapse of 11.4%. Conventional vaginal prolapse surgery has been associated with high anatomic failure rates.3 This has led to the introduction of graft materials. Randomized controlled trials revealed improved anatomic outcomes after vaginal polypropylene mesh when compared with traditional vaginal prolapse repairs.4,5 However, the use of synthetic mesh in the vagina introduced different types of complications. The International Urogynecology Association and International Continence Society developed a classification of complications related to the insertion of grafts.6
Mesh exposure is the most commonly reported complication associated with the use of mesh in prolapse surgery. Exposures have been reported as early as 6 weeks and late as 4 years after vaginal mesh surgery, but they usually occur during the first year after the intervention.7–9 Reported exposure rates vary between 0% and 25%.4,5,10,11 In previous studies, various predictive factors for mesh exposure such as patient age, experience of the surgeon, cystocele stage II or lower, and concomitant hysterectomy have been reported.4,12–17
Mesh exposure and shrinkage of fibrous tissues around the mesh may result in pelvic pain and dyspareunia. Dyspareunia rates of up to 38% have been reported after vaginal mesh placement.7 De novo pain rates between 3% and 10% have been reported; however, risk factors have not been identified until now.5,18,19 The objective of this study was to identify possible risk factors for mesh exposure, dyspareunia, and pain at 12 months after tension-free vaginal mesh insertion in a large cohort study.
MATERIALS AND METHODS
This prospective observational cohort study was performed in two Dutch centers specializing in pelvic organ dysfunction and surgery (Radboud University Nijmegen Medical Centre and Reinier de Graaf Group Delft, both in the Netherlands). The first pelvic organ prolapse repair with tension-free vaginal mesh (Prolift, Ethicon) was performed in September 2005 in both centers. This analysis includes all trocar-guided tension-free vaginal mesh procedures between September 2005 and December 2009. The choice for conventional pelvic organ prolapse surgery or tension-free vaginal mesh surgery was left to the discretion of the surgeon and the patient. Common practice was to counsel women at higher risk for recurrence for pelvic organ prolapse for tension-free vaginal mesh. In practice, these were patients with a recurrent pelvic organ prolapse stage II or higher and patients with a primary pelvic organ prolapse stage III or higher who opted for tension-free vaginal mesh. Exclusion criteria were pregnancy or contemplating future pregnancy or a compromised immune system. All data were collected as part of an ongoing outcome registration project, which was approved by CMO regio Arnhem-Nijmegen Human Research Committee on April 19, 2006.
Surgery was performed by four gynecologists who were formally trained for the tension-free vaginal mesh procedure as described by Fatton et al20 before the start of this study. Operations were sometimes performed by a combination of two gynecologists or by residents under supervision of a gynecologist. With regard to the “factor” surgeon, these operations were categorized under the first surgeon or the supervisor, respectively. As recommended, a full-thickness midline incision was made through the fibromuscular wall of the vagina. No simultaneous hysterectomy or T-incisions were made to reduce the already known risk of mesh exposure.12 Other additional conventional surgical procedures such as sacrospinous ligament fixation, anterior and posterior colporrhaphy, or modified Manchester-Fothergill were permitted.
Perioperatively, all patients received antibiotic prophylaxis. An indwelling urinary catheter for 1 or 2 days and vaginal gauze pack for 1 day were inserted after completion of surgery.
Baseline evaluation included medical history and assessment of pelvic organ prolapse by the pelvic organ prolapse quantification system.21 Data on subjective symptoms, such as pain and dyspareunia, were obtained from the standardized and validated urogynecological questionnaire (Urogenital Distress Inventory).22 In this self-completed questionnaire, patients were asked to state whether pain and dyspareunia were present or absent; and if it was present, the patient was asked for the amount of bother on a 4-point Likert scale with scores ranging from “no bother at all” to “quite a bit of bother.” In this study, pain and dyspareunia were considered present if a patient responded at least “yes, moderately bothered” to the questions “do you experience pain in the lower abdomen or genital region?” and “do you experience pain during intercourse?”, respectively. Quality of life was assessed using EuroQuol 5D.23 Health status was quantified using a visual analog scale in which zero denotes the worst imaginable health status and 100 denotes the best imaginable health status.
Follow-up visits were planned at 6 weeks and at 6 and 12 months and included pelvic organ prolapse quantification, symptom assessment (questionnaire), and complication assessment. Anatomic failure was defined as pelvic organ prolapse stage II or higher of the treated compartment. Mesh exposure was defined as any visible or palpable mesh identified during vaginal examination or visualized during cystoscopy or rectosigmoidoscopy in case of an indication for these examinations. Complications were prospectively collected on a case record form and included rectal lesion, bladder injury, blood loss more than 500 mL, infection, hematoma, urinary retention (defined as repeated postvoid residual volume more than 100 mL measured with a bladder scanner and needing an indwelling Foley catheter or intermittent catheterization), reintervention attributable to complication, granuloma, exposure, pelvic abscess, rectovaginal or vesicovaginal fistula, pain, and dyspareunia.
Data are presented as numbers with corresponding percentages or medians with range. The Wilcoxon signed rank test was used to test differences between related samples for statistical significance. The χ2 test was used to compare proportions. Primary outcomes of this study were mesh exposure, dyspareunia, and pain within 12 months after the tension-free insertion of vaginal mesh.
Univariable logistic regression was used to study the influence of the possible risk factors on each of the outcomes, separately. Considered risk factors were patient age, menopause, diabetes, body mass index, parity, current smoking, pelvic organ prolapse stage, previous pelvic organ prolapse surgery, anterior mesh, posterior mesh, total mesh, tension-free vaginal mesh combined with conventional prolapse surgery, operating time, amount of blood loss, any complication perioperatively or postoperatively, bladder injury, postoperative hematoma, surgeon, clinical and surgical experience of the surgeon (in every separate case, the number of years of experience of the particular surgeon was calculated at that moment), number of tension-free vaginal mesh procedures previously performed by that surgeon, failure (pelvic organ prolapse stage II or higher) in the mesh-treated compartment, and postoperative sexual activity. Postoperative sexual activity was defined as a positive response to the question regarding having sexual intercourse. The odds ratio (OR) with the 95% confidence interval (CI) are presented.
Multivariable logistic regression with forward selection procedure was used to identify those variables that were independently related to predict mesh exposure, dyspareunia, and pain, separately. Variables reaching statistical significance at the P<.10 level in the univariable analysis were valid for entry model in the selection procedure. It is generally recommended to put this level not too low, because otherwise possible (adjusted) predictors remain unrevealed. The adjusted OR with 95% CI of the final model are presented. P<.05 was considered statistically significant. Statistical analysis was performed using SPSS 15.0 for Windows.
Between September 2005 and December 2009, 1,894 patients underwent pelvic organ prolapse surgery in the two centers. Three hundred seventy-four women met the inclusion criteria and underwent a trocar-guided tension-free vaginal mesh procedure. The 12-month follow-up data were available for 294 patients (79%). Details of 116 patients have previously been described in a study that focused on de novo prolapse in the untreated compartment, and 46 patients were part of a randomized controlled trial on tension-free vaginal mesh.5,24 Baseline characteristics are presented in Table 1. Median age was 64 years, with a range of 16–93 years. A 16-year-old girl had spina bifida and a descending uterus 1 cm past the hymen.
Table 2 shows the surgical procedures that were performed and the perioperative and postoperative complications. Seven (2.1%) bladder perforations occurred, all during dissection for an anterior tension-free vaginal mesh procedure. In two of these patients, the anterior mesh has not been placed for that reason, and a conventional anterior colporrhaphy was performed in combination with a posterior mesh procedure. One superficial serosa lesion of the rectum occurred, without perforation, and the mesh was placed in this patient. Three patients underwent reintervention because of postoperative bleeding. One of these women had a large hematoma in the retroperitoneal space of Retzius attributable to a lesion of the left obturator artery. Laparotomy through a median incision was performed and the bleeding branch of the obturator artery was ligated. The total estimated blood loss of this second procedure was 5,200 mL. There were no pelvic abscesses or rectovaginal and vesicovaginal fistulas in this series.
In 34 patients (12%), a mesh exposure was present in six cases detected at 6 weeks, in 17 at 6 months, and in 11 at 12 months. Most of these patients were asymptomatic, three patients reported dyspareunia, and two had vaginal bleeding or discharge. Fifteen (44%) of these exposures were localized in the anterior vaginal wall after an anterior or total mesh placement, 16 (47%) in the posterior wall after a posterior or total mesh placement and three (9%) in the apex of the vagina after a total or a posterior mesh placement. The size of the exposures ranged from 2 to 60 mm (median 10 mm). Figure 1 shows the follow-up of these patients with exposure. Twenty-three exposures (68%) resolved after therapy. The percentage of mesh exposures per surgeon varied between 8% and 29%.
Pain in the lower abdomen or genital region was present in 62 out of 252 patients (25%) before surgery and in 35 out of 275 patients (13%) after surgery. De novo pain was noted in 5%.
Data regarding sexual activity and dyspareunia are presented in Figure 2. De novo dyspareunia was noted in 20 out of 78 patients (26%) and resolved dyspareunia in 19 of 60 patients (32%). Twenty of 98 patients (20%) returned to sexual activity, of which the majority (12) experienced dyspareunia and 7 out of 140 (5%) ceased sexual activity after their surgical repair.
Anatomic outcomes are shown in Table 2. The failure rate in the mesh-treated compartments was 13% (38 patients), of which 32 (84%) were asymptomatic. Two patients (1%) had a pelvic organ prolapse stage III, both with bulge symptoms. One of these women underwent repeat pelvic organ prolapse surgery and the other patient abstained from further treatment. Four patients (2%) had a symptomatic pelvic organ prolapse stage II, of whom two underwent repeat pelvic organ prolapse surgery during the follow-up period. Overall quality of life measured on a visual analog scale according to the EuroQuol 5D improved significantly from a median of 70 (16–100) to 80 (20–100) 1 year after pelvic organ prolapse surgery (P=.002, Wilcoxon).
Table 3 shows the crude OR with 95% CI for the risk of exposure, the risk of pain, and the risk of dyspareunia. We found that the type of surgeon and years of experience of the surgeon were statistically significant and related to the risk of exposure. However, only the years of experience was an independent risk factor for exposure (Table 4). Each decade increase in clinical and surgical experience decreased the risk of exposure (OR 0.49, 95% CI 0.29–0.83).
Smoking, total tension-free vaginal mesh, and experience of the surgeon were independently associated with the presence of mesh exposures (Table 4). Of the 30 smoking women, nine (30%) had an exposure in contrast to only 25 out of the 264 (9%) nonsmokers (P<.001, χ2 test).
An independent association between surgeon and postoperative dyspareunia was detected that could not be explained by the number of previously performed tension-free vaginal mesh procedures or by the years of experience (Table 4). Pain and dyspareunia before surgery were the independent risk factors for these symptoms after surgery, respectively (Table 4), indicating that the symptoms persisted after surgery. Furthermore, preoperative health status was inversely related to pain and dyspareunia after surgery.
This prospective observational cohort study demonstrated that smoking, total tension-free vaginal mesh, and less clinical and surgical experience were independent risk factors for mesh exposure after a tension-free vaginal mesh procedure. Lower abdominal or genital pain before surgery was independently associated with pain after surgery. Preoperative dyspareunia and the surgeon were both independent predictive factors for postoperative dyspareunia.
This study is about an actual and highly relevant topic in urogynecological practice. Vaginal meshes have been widely applied in recent years, but there is still little scientific evidence on the pros and cons, as well as the risk factors for postoperative problems. Further strengths are the prospective design of the study, the large sample size, and the use of standardized and validated instruments of measurement.
A drawback could be the relatively short follow-up period of 12 months. However, it has been reported previously that most complications and, particularly, mesh exposures occur during this first year after surgery.9 Furthermore, an independent clinical investigator who was not involved in and blinded to the procedures would ideally have performed the postoperative examinations.
This study identified tobacco smoking as an independent risk factor for mesh exposure after the tension-free vaginal insertion. Previously, Cundiff et al25 had demonstrated that smoking was a risk factor for vaginal mesh exposure after abdominal sacrocolpopexy in univariable analysis. Other authors12,16,17,26 have not reported on smoking as a potential risk factor or have failed to demonstrate an association with exposure.15 Nicotine is a vasoconstrictor that reduces nutritional blood flow to the epithelium, resulting in tissue ischemia and impaired healing, which eventually might lead to vaginal mesh exposure.27 Slower wound healing clinically has been observed in smokers.27 Four weeks of abstinence from smoking already reduced smoking-associated complications.28
We have identified the total tension-free vaginal mesh as a risk factor for exposure. Apart from the fact that a total mesh contains a larger amount of mesh, the technique to insert a total mesh probably is more complex. The special technique that leaves a small bridge of vaginal vault intact29 may jeopardize the vascularization of the vaginal tissue and could be responsible for poor wound healing and, thus, mesh exposure.
The years of experience in prolapse repair, and not necessarily the number of previously performed tension-free vaginal mesh procedures, appeared to be protective for mesh exposure. One previous article26 also suggested an association, although not statistically significant, between surgical experience and exposure.
In contrast with a previous study of 52 sexually active patients, we could not demonstrate that “postoperative sexual activity” was independently associated with mesh exposure.16 This study, however, did not consider smoking as a risk factor.
In literature, data on age as an independent risk factor for mesh exposure are conflicting.16,17,26 We could not demonstrate any association between age and exposure in the present study.
A de novo pain rate of 5% is consistent with earlier reports.5,18 We found an increased risk for pain after surgery in patients with pain in the lower abdomen or genital region before surgery. This was to be expected because this pain is not necessarily related to prolapse and, in such cases, is not likely to resolve with pelvic organ prolapse surgery.
The rates of dyspareunia after surgery (45%) and de novo dyspareunia (26%) were similar to the rates reported by Carey et al30 (40% and 28%, respectively). However, other authors4,16,19 reported lower (7.6–20%) dyspareunia rates after surgery with vaginal mesh and lower de novo dyspareunia rates (2–12.3%). This study clearly demonstrates that preoperative dyspareunia increases the odds of postoperative dyspareunia, probably persistent dyspareunia. We were surprised by the differences in dyspareunia rates between surgeons. We have no good explanation for this. One has to realize that because not all patients were sexually active, the number of operations per surgeon was relatively small, illustrated by the high 95% CI. Furthermore, dyspareunia is a complicated topic and more detailed questions about sexuality might explain more.
When counseling a woman with pelvic organ prolapse for conventional compared with vaginal mesh repair, the potential complications such as mesh exposure, pain, and dyspareunia should be mentioned along with the differences in anatomic success rates. The present study may aid in a more individualized counseling, and we do suggest advising patients to quit smoking before mesh surgery. Furthermore, pain or dyspareunia may not necessarily disappear after pelvic organ prolapse surgery.
This study indicates that tension-free vaginal mesh surgery was safer if performed by more experienced urogynecological surgeons. The number of previous years of surgical and clinical experience seemed to be relevant. In the Netherlands, the Pelvic Floor Society of the Dutch Society of Obstetrics and Gynecology is working on standards for vaginal mesh surgery. Centralization of mesh procedures performed by surgeons with proven experience would imply a major shift in referrals. The results of the present study, however, indicate that this discussion on the future organization of vaginal mesh surgery is mandatory.
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© 2011 by The American College of Obstetricians and Gynecologists. Published by Wolters Kluwer Health, Inc. All rights reserved.