To investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy.
To investigate the anatomical cure rate and complications related to collagen-coated mesh for cystocele, compared with a conventional anterior colporrhaphy.
A randomised controlled study.
Six departments of obstetrics and gynaecology in Norway, Sweden, Finland, and Denmark.
Women aged 55 years or older, referred for surgery with a prolapse of the anterior vaginal wall of stage 2 or higher.
Women scheduled for primary cystocoele surgery were randomised to either anterior colporrhaphy or a collagen-coated Prolene mesh. Power analysis indicated that 130 patients had to be randomised. All patients were evaluated using the Pelvic Organ Prolapse-Quantification (POP-Q) measurement. Quality of life, symptoms, and sexual function were evaluated using the Pelvic Floor Impact Questionnaire, the Pelvic Floor Distress Inventory, and the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire.
The primary outcome was objective cure, defined as prolapse below POP-Q stage 2 at the 12-months follow-up. Secondary outcomes were quality of life, symptoms, and presence (or not) of complications.
In total, 161 women were randomised to either anterior colporrhaphy or mesh (participant ages 64.9 ± 6.4 years versus 64.7 ± 6.6 years, respectively; mean ± SD). The objective cure rate was 39.8% (95% CI 28.6–50.9%) in the anterior colporrhaphy group, compared with 88.1% (95% CI 80.7–95.6%) in the mesh group (P < 0.001). Vaginal mesh exposure occurred in ten women (13.3%) and dyspareunia occurred in two women (2.7%, not significant) in the mesh group at the 12-months follow-up. Questionnaires revealed no difference between the groups.
Our study demonstrates a significantly improved objective cure rate associated with a high exposure rate among women with mesh surgery as opposed to conventional surgery.
Pelvic organ prolapse (POP) is a well-known condition that affects approximately 11% of women in the western world. The condition has a great impact on women's wellbeing, and therefore many women have their prolapse corrected surgically. Although anterior colporrhaphy is the procedure of choice for correcting defects in the anterior vaginal compartment, high objective recurrence rates of up to 40% are observed. Consequently, there has been much interest in trying to avoid recurrence, and thereby the complications associated with re-operation.[2, 3]
During the last decade new surgical techniques have been developed and introduced, including the use of biological and synthetic mesh. Recently, we published data on the efficacy of a biological mesh in the anterior compartment. Our study demonstrated no improvement in the recurrence rate when using biological mesh compared with a standard anterior repair, in agreement with previous studies.[5, 6] Others have demonstrated that synthetic mesh may be superior to a standard anterior repair. In 389 women randomly assigned to either a traditional colporrhaphy or a trocar-guided, transvaginal, polypropylene mesh repair, Altman et al. observed that the mesh procedure resulted in higher short-term success than the traditional method, but also an increased rate of surgical complications such as bladder perforation and erosions. Other studies have observed a similar higher cure rate in women with anterior vaginal wall defects following the implantation of a polypropylene mesh.[8-11]
Some authors have evaluated the use of polypropylene; others have advocated that coating the mesh may decrease complications such as erosions or mesh exposure.[12-14] The theory behind this is that coating may improve the in-growth of tissue and capillary vessels in the mesh. So far, however, only a few published series have described whether such a mesh improves the cure rate and lowers the risk of complications.
The aim of our study was therefore to compare the efficacy – measured as difference in anatomical recurrence rate – of a collagen-coated, non-absorbable monofilament polypropylene mesh (Avaulta Plus® Biosynthetic Support System; CR Bard, Murray Hill, NJ, USA) with that of standard anterior colporrhaphy in primary surgery of anterior wall defects. Secondary outcomes were quality of life, symptoms, and complications (frequency of erosions, postoperative infections, and dyspareunia).
Recently the US Food and Drug Administration (FDA) advocated against the widespread use of synthetic meshes in POP surgery, describing serious complications following mesh implantation for vaginal wall defects. This study is consistent with the need for more knowledge regarding the limitations and advantages of mesh.
All participants were recruited from the six departments taking part in this study. This was to improve the generalisability of the outcome data. The departments were situated in Denmark, Norway, Sweden and Finland. The period of inclusion in the study was April 2008 to December 2010. The participants were screened by the surgeons involved, who also performed the Pelvic Organ Prolapse-Quantification (POP-Q) assessment. The women were examined in the supine position at maximum Valsalva. Only women aged 55 years or over and with anterior vaginal wall prolapse of stage 2 or higher, according to the POP-Q classification, were included. Exclusion criteria were: a history of previous major pelvic surgery, with the exception of a hysterectomy for reasons other than genital prolapse, previous vaginal surgery, or hysterectomy for POP; concomitant prolapse of the uterus or an enterocele of stage 1 or higher; previous incontinence sling surgery performed through the obturator membrane; current treatment with corticosteroids; or a history of genital or abdominal cancer. All women filled in the short forms of the Pelvic Floor Impact Questionnaire (PFIQ-7), the Pelvic Floor Distress Inventory (PFDI-20), and, if sexually active, the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12) at baseline and at follow-up.[18, 20] The PFIQ-7 and the PFDI-20 questionnaires consist of three subscales each. PFIQ-7 describes the different impacts on a woman's social life related to urinary tract (UIQ-7), bowel or rectal (CRAIQ-7), and vaginal or pelvic (POPIQ-7) symptoms. PFDI-20 reflects different perspectives of bulging symptoms (POPDI-6), bowel problems (CRADI-8), and urinary leakage and other lower urinary tract symptoms (UDI-6). PISQ-12 describes sexual function in relation to prolapse or urinary incontinence. Increasing scores of PFIQ-7 and PFDI-20 indicate impaired function, whereas in PISQ-12, a higher score indicates better sexual function.
The study was performed as a clinically controlled randomised study. After receiving verbal and written information, and accepting the study, participants were randomised in blocks corresponding to each centre by a computer-generated list in a ratio of 1:1 to either a standard anterior colporrhaphy using intermittent Vicryl, or similar (absorbable) 2–0 sutures in the pubocervical fascia, or the Avaulta Plus- anterior biosynthetic mesh procedure. The allocation was performed using sealed opaque envelopes. A follow-up was made at 3 and 12 months with a gynaecological examination, exploring possible erosions or mesh exposure, POP-Q measurement, residual urine, and questionnaires.
The anterior colporrhaphy was performed using a midline incision, and the bladder was dissected from the vaginal mucosa by blunt or sharp dissection. The pubocervical fascia was plicated using intermittent 2–0 absorbable sutures, and excess vaginal mucosa was excised. The vaginal mucosa was closed using a running resorbable unlocked suture. A vaginal pack was placed, if necessary, for not more than 6 hours. The catheter was removed simultaneously with the vaginal pack or retained as long as needed if the woman had an epidural analgesia. The mesh procedure was performed in accordance with the description by the company. All surgeons were trained in the two procedures together to ensure that identical techniques were used.
The mesh used, the Avaulta Plus® anterior biosynthetic system, is a monofilament, polypropylene mesh, in which the central section is coated with an absorbable hydrophilic film of porcine collagen. The porcine film is supposed to minimise the attachment of viscera to the mesh during the healing process.
The participants received cephalosporin 1500 mg and/or metronidazole 1500 mg intravenously as a single dose just prior to surgery.
All the women were recommended to start with local estrogen treatment at inclusion, and to continue the treatment for at least 3 months after the surgical procedure.
The study was performed in accordance with intention-to-treat regulations. Imputation was performed as last-observation carry-forward imputation on the main outcome (i.e. POP-Q) for participants at the final follow-up. Calculation of the required number of participants was based on a two-sided hypothesis, with a risk of type-1 error of 5% and an 80% power to detect a difference of 20% in recurrence rate (defined as a stage-2 cystocele or higher at 12 months of follow-up) between the two groups. Accordingly, 112 participants had to be randomised. Anticipating a drop-out rate of 15%, the number of participants was increased to 130. Data were collected and evaluated by spss 21 (SPSS Inc., Chicago, IL, USA). Comparisons between groups were made by Fisher's exact test, the chi-squared test, the Mann–Whitney U-test, or by Friedman's test, when appropriate. The Wilcoxon sign-rank test served as a post hoc test to the Friedman's test. Because of multiple comparisons, a reduced P-value (Bonferroni method) was used to control for the risk of mass significance. An independent statistician performed all analyses with no information about the treatment assignments.
The study was approved by the ethical committees in Denmark, Finland, Norway, and Sweden, and was registered at Clinical Trials (NCT00627549).
Figure 1 shows a flow chart of the participants. One hundred and sixty-nine women were available for screening and randomisation, according to the generated randomisation list. Of these 169, eight women were not randomised: four did not fulfil the inclusion criteria, but had signed informed consent; two could not accept randomisation; and two did not wish to have surgery after they had signed informed consent. Four women who were randomised to anterior colporrhaphy and underwent the operation did not wish to fulfil the study protocol for personal reasons; however, two of these women completed the questionnaires at the 12-month follow-up. During the study period two women allocated to mesh dropped out and did not wish to continue in accordance with the study protocol: they were therefore lost to follow-up. Two participants randomised to mesh had bladder perforation and had a standard anterior colporrhaphy. One continued in the mesh group following the intention-to-treat analysis, whereas the other was lost to follow-up.
No difference between baseline characteristics was observed (Table 1). As observed from Tables 2 and 3, the POP-Q stages were equal at baseline in the two groups. The majority of participants had a stage-3 cystocele.
|Avaulta Plus® mesh (n = 79)||Anterior colporrhaphy (n = 82)|
|Age (years), mean ± SD (range)||64.9 ± 6.4 (55–84)||64.7 ± 6.6 (55–81)|
|BMI (kg/m2), mean ± SD (range)||26.5 ± 5.1 (19.0–57.4)||25.7 ± 3.1 (18.8–35.8)|
|Parity (range)||2.4 ± 1.0 (0–7)||2.3 ± 1.0 (0–5)|
|Postmenopausal, n (%)||79 (100)||82 (100)|
|On HRT, n (%)||52 (66.7)||53 (64.6)|
|Systemic HRT, n (%)||7 (8.9)||6 (7.5)|
|Vaginal HRT, n (%)||48 (61.5)||50 (62.5)|
|Smokers, n (%)||8 (10.3)||12 (14.6)|
|Hypertension, n (%)||29 (37.2)||26 (31.7)|
|Diabetes, n (%)||1 (1.3)||4 (4.9)|
|Depression, n (%)||2 (2.6)||1 (1.2)|
|Cardiovascular disease, n (%)||2 (2.6)||3 (3.7)|
|Pulmonary disease, n (%)||5 (6.4)||1 (1.2)|
|Previous hysterectomy, n (%)||6 (7.7)||12 (14.6)|
|Previous prolapse surgery, n (%)||0||1 (1.2)|
|Urinary incontinence, n (%)||28 (35.9)||33 (40.2)|
|Stress urinary incontinence, n (%)||5 (17.2)||13 (39.4)|
|Urge urinary incontinence, n (%)||9 (32.1)||9 (27.3)|
|Mixed urinary incontinence, n (%)||14 (50.0)||11 (33.3)|
|Residual urine (ml), mean ± SD (range)||41.7 ± 50.3 (0–275)||42.5 ± 52.5 (0–272)|
|Inclusion POP-Q||3-months follow-up POP-Q||12-months follow-up POP-Q||Comparison over time (mesh)||Comparison over time (ant. colp.)|
|Mesh (n = 79)||Ant. colp. (n = 82)||P-valuea||Mesh (n = 76||Ant. colp. (n = 82)||P a||Mesh (n = 76)||Ant. colp. (n = 78)||P a||P b||P b|
|Aa||1.4 ± 1.1 (−1.0 to +4.0)||1.2 ± 1.3 (−2.0 to +3.0)||0.250||−2.7 ± 0.6 (−3.0 to 0.0)||−1.7 ± 1.2 (−3.0 to +1.5)||<0.001||−2.4 ± 1.1 (−3.0 to +3.0)||−1.1 ± 1.4 (−3.0 to +3.0)||<0.001||<0.001 A, B, C||<0.001 A, B, C|
|Ba||2.1 ± 1.1 (0.0 to +5.0)||2.0 ± 1.6 (−1.0 to +4.0)||0.842||−2.6 ± 0.6 (−3.0 to 0.0)||−1.3 ± 1.2 (−3.0 to +1.5)||<0.001||−2.4 ± 1.2 (−3.0 to +4.0)||−0.8 ± 1.5 (−3.0 to +3.5)||<0.001||<0.001 A, B, C||<0.001 A, B, C|
|C||−4.2 ± 1.9 (−10.0 to −1.0)||−4.0 ± 1.6 (−10.0 to −1.0)||0.613||−6.5 ± 1.7 (−10.0 to −3.0)||−5.5 ± 1.9 (−10.0 to +1.0)||0.002||−6.4 ± 2.2 (−10.0 to +3.0)||−5.3 ± 2.1 (−10.0 to +1.5)||<0.001||<0.001 A, B||<0.001 A, B|
|Gh||4.1 ± 0.8 (2.0–6.0)||4.3 ± 0.8 (3.0–7.0)||0.183||4.0 ± 0.8 (2.5–6.0)||4.1 ± 0.8 (3.0–7.0)||0.901||4.1 ± 0.8 (2.0–6.0)||4.1 ± 0.9 (2.0–6.5)||0.702||0.404||<0.001 A, B|
|Ph||3.5 ± 0.6 (2.0–5.0)||3.5 ± 0.7 (2.0–5.0)||0.941||3.6 ± 0.6 (2.0–5.0)||3.6 ± 0.6 (2.0–5.0)||0.450||3.6 ± 0.6 (2.0–5.0)||3.6 ± 0.6 (2.0–5.0)||0.844||0.027||0.288|
|TVL||8.3 ± 1.2 (5.0–11.0)||8.2 ± 1.4 (4.5–10.0)||0.880||8.5 ± 1.0 (6.0–11.0)||8.1 ± 1.3 (4.0–10.0)||0.070||8.4 ± 1.2 (6.0–11.0)||8.1 ± 1.4 (4.0–10.0)||0.125||0.011 A||0.895|
|Ap||−1.8 ± 0.8 (−3 to 0)||−1.9 ± 1.1 (−3.0 to +2.5||0.224||−1.9 ± 0.9 (−3.0 to +1.0)||−2 ± 1.0 (−3.0 to +2.0)||0.675||−1.6 ± 1.2 (−3.0 to +3.0)||−1.9 ± 1.0 (−3.0 to +2.0)||0.386||0.337||0.087|
|Bp||−1.8 ± 0.7 (−3.0 to +1.0)||−1.8 ± 1.2 (−3.0 to +4.0)||0.322||−1.8 ± 0.9 (−3.0 to +1.0)||−1.9 ± 1.1 (−3.0 to +3.0)||0.288||−1.5 ± 1.3 (−3.0 to +3.0)||−1.8 ± 1.0 (−3.0 to +2.0)||0.272||0.155||0.313|
|POP-Q stage||Inclusion, n (%)||3-months follow-up, n (%)||12-months follow-up, n (%)|
|Mesh (n = 78)||Ant. colp. (n = 82)||P||Mesh (n = 76)||Ant. colp. (n = 82)||P||Mesh (n = 76)||Ant. colp. (n = 78)||P|
|0||0||0||0.976||48 (63.2)||17 (20.7)||<0.001||46 (60.5)||8 (10.3)||<0.001|
|1||0||0||25 (32.9)||25 (30.5)||21 (27.6)||23 (29.5)|
|2||23 (29.5)||24 (29.3)||3 (3.9)||38 (46.3)||8 (10.5)||40 (51.3)|
|3||55 (70.5)||58 (70.7)||0||2 (2.4)||1 (1.3)||7 (9.0)|
Tables 2 and 3 show that women in both groups improved significantly with regard to the POP-Q measurements related to the anterior compartment, but also the cervix (row C, Table 2) was significantly improved over time in both groups. Table 3 demonstrates that a significantly higher number of women randomised to a standard anterior colporrhaphy had a higher POP-Q stage at 3- and 12-months follow-up, compared with the mesh group. The only woman who had a stage-3 prolapse in the mesh group was the one who had a bladder injury at surgery, and therefore did not have a mesh inserted.
Surgical outcome is presented in Table 4, which demonstrates that anterior colporrhaphy is associated with more frequent use of local anaesthesia, a shorter duration of surgery, and a shorter hospital stay. One woman allocated to the mesh group had a blood transfusion. She was discharged from hospital the following day without any problems, and attended the follow-up appointments. Furthermore, Table 4 describes the number of patients undergoing a posterior repair.
|Mesh (n = 78)||Anterior colporrhaphy (n = 82)||P|
|Anaesthesia, n (%)|
|Spinal||29 (37.2)||29 (35.4)||<0.001a|
|General||49 (62.8)||30 (36.6)|
|Duration of surgery (min)|
|Mean ± SD||47.8 ± 23.6||31.6 ± 17.6||<0.001b|
|Time at OR (min)|
|Mean ± SD||74.1 ± 32.6||63.4 ± 23.7||<0.001b|
|Hospital stay <12 h, n (%)||16 (21.6)||37 (45.7)||0.002a|
|Hospital stay <24 h, n (%)||58 (78.4)||44 (54.3)|
|Additional post. colp.||5 (6.4)||6 (7.3)||0.821a|
|Bladder perforation||2 (2.6)||0||0.236c|
|Bleeding >500 ml||1 (1.3)||0||0.487c|
|Blood transfusion||1 (1.3)||0||0.487c|
|Urinary tract infection||2 (2.6)||2 (2.4)||0.999c|
|Urinary retention||3 (3.8)||2 (2.4)||0.676c|
At the 3-months follow-up nine women had mesh exposure: three of these had the mesh resected locally, whereas the remaining six had no symptoms and were treated conservatively. Of those who underwent surgery, one healed without problems, as did one woman who was conservatively treated. The remaining women still showed mesh exposure at the 12-months follow-up. In addition three new erosions were detected, giving a total of ten exposures (13.3%) at the 12-months follow-up. The largest exposure at the 12-months follow-up was 1.5 cm2. In the conservatively treated patients the defects were very small, exposing less than 5 mm of the mesh and not causing any problems to the women, who are still being followed (Table 5). Two women had a greater and smaller part of the mesh, respectively, removed during the study period because of infection. They both healed without any further complications, and had no recurrence at the 12-months follow-up. Two other cases in the mesh group had smaller infections healed by antibiotics. New-onset stress urinary incontinence was observed slightly more frequently in the mesh group (P = 0.057; Table 5).
|Mesh, n (%)||Anterior colporrhaphy, n (%)||P|
|Urinary tract infection||5 (6.7)||10 (13.0)||0.191a|
|Vaginal discharge||4 (5.3)||3 (3.9)||0.717b|
|New SUI||4 (5.3)||0 (0.0)||0.057b|
|New UUI||1 (1.3)||1 (1.3)||0.999b|
|Voiding difficulties||2 (2.7)||0 (0.0)||0.242b|
|New dyspareunia||2 (2.7)||0 (0.0)||0.242b|
|Exposures||10 (13.3)||0 (0.0)||0.001b|
|Residual urine (ml), mean ± SD||19.1 ± 26.1||16.0 ± 19.6||0.518c|
Subjective outcome was measured by questionnaires throughout the study at baseline, and at the 3- and 12-month follow-up appointments. Both groups showed a statistically significant improvement of all domain scores at follow-up (P = 0.001). No difference was observed between the two groups, except at the 12-months follow-up, where the sensation of vaginal bulging was perceived significantly more often in the anterior colporrhaphy group (P = 0.044; Table 6).
|Mesh, mean total score (SD)||Anterior colporrhaphy, mean total score (SD)||P a|
|PFIQ-7||13.1 (33.4)||19.0 (38.9)||0.260|
|UIQ-7||6.2 (13.2)||9.6 (18.3)||0.166|
|CRAIQ-7||4.6 (12.8)||6.6 (16.8)||0.195|
|POPIQ-7||3.1 (10.3)||5.2 (13.1)||0.322|
|PFDI-20||42.1 (44.0)||54.6 (44.9)||0.077|
|POPDI-6||10.7 (14.5)||16.0 (17.2)||0.044|
|CRADI-8||14.4 (16.4)||17.4 (16.5)||0.171|
|UDI-6||16.7 (16.9)||20.9 (20.9)||0.368|
|PISQ-12||11.9 (5.5)||13.1 (5.6)||0.284|
The number of women who were sexually active was equal in the two groups. The PISQ-12 questionnaire was answered by 36 (47.4%) sexually active women from the mesh group and 48 (61.5%) from the anterior colporrhaphy group. Only two women in the mesh group (2.7%) experienced dyspareunia for the first time (Table 5). No difference was observed between the two groups with regard to PISQ-12 scores.
This randomised, controlled trial demonstrates that trocar-guided collagen-coated mesh is associated with a significantly better anatomical outcome, indicated by the smaller number of women with stage-2 or higher anterior vaginal wall prolapse at the 12-month follow-up in the mesh group, compared with the colporrhaphy group. Rather surprisingly, we observed that 48% of the women allocated to the anterior colporrhaphy group already demonstrated an objective stage-2 or higher anterior vaginal wall prolapse at the 3-months follow-up, followed by an increase to 60% at the 12-month follow-up (Table 3). In the mesh group the recurrence rate was only 4 and 14%, respectively; however, as no one in the anterior colporrhaphy group felt the need for further surgical treatment, this may merely reflect the doctors’ perspectives rather than participants' views. This phenomenon has also been observed by others.[7, 11] We observed a slightly higher number of women with vaginal bulging symptoms following anterior colporrhaphy. This is surprising, as no one in this group required a secondary repair during the 12-month period. This contradicts the observation by Barber et al., who concluded that the absence of vaginal bulging may be crucial to the definition of success.
The reason for the observed higher objective recurrence rate in the anterior colporrhaphy group is not clear. So far, we agree with Vollebregt et al. that mesh implantation may not be justified as a first-line therapy because only a small number of patients seek further surgical treatment. As we are planning a 3-year follow-up we may be able to clarify this.
There is no difference between the two groups regarding PISQ-12 scores. The rate of dyspareunia is in accordance with some previous studies,[7, 11] but some other studies indicate a higher incidence.[3, 10, 21, 22] This may be because of differences in study population and surgical methods, including mesh types. The results may also be influenced by the rather high mean age of the women in our study, with a considerable proportion of them not being sexually active. Several studies describe improvement in the PISQ-12 score, or no significant worsening[7, 11]; however, further specific investigations are needed in order to specify the extent of problems associated with sexual wellbeing following mesh surgery.
Complications arising from mesh insertion are well described.[23, 24] We observed the same type of complications but at a very low rate, except for exposure rate. The exposure rate in our study was rather high compared with the rates reported in some previous randomised studies,[7, 11] but was comparable with rates reported in others.[3, 10, 21, 22] Whether the exposure rate results from the coating of the mesh is not clear, but coated mesh does not appear to have any advantages compared with non-coated mesh, although previous work may indicate a benefit.
The exposures were predominantly observed in one centre (n = 7). We do not have any explanation for this local high occurrence, as all the surgeons were very experienced and were trained preoperatively. Furthermore, each centre has participated in previous multicentre trials, including for vaginal mesh surgery.
Altman et al. observed a higher rate of new-onset stress urinary incontinence. We observed a tendency towards this, but not at a significantly increased rate, in the mesh group. The reason may be as suggested previously: that is, the mesh may overcorrect the position of the bladder neck and/or urethra. In our study the leakage was minor, and none of the women had a sling inserted to treat stress incontinence. No difference was observed in urge incontinence between the groups.
As noted by several authors,[7, 15] it is difficult to compare the results obtained in our study with those of other randomised trials because any other vaginal procedures that interfered with the anterior compartment precluded participation in our study, although the conventional repair of defects in the posterior compartment was allowed if the apical compartment, defined as level 1 according to DeLancey et al., was not involved. Furthermore, this study is the first to describe the usefulness of a mesh coated with porcine collagen. Other studies have included a variety of participants, including those scheduled for repair in the anterior compartment, and also sacrospinous hysteropexy, including recurrent cases,[3, 7, 26] as well as different types of fixation systems.[10, 21] However, it appears that the results obtained from recent randomised trials are comparable with ours regarding the anatomical cure rate, despite the inclusion of a mixture of the aforementioned types of surgery or participants. Therefore, it seems logical to conclude that defects in the anterior compartment may be corrected by mesh in recurrent cases, when different compartments are involved, or when other types of procedures are included.
Although our study was performed as a randomised trial it may have some limitations. The surgeons who carried out the postoperative assessment were aware of the procedure, which may have interfered with the POP-Q assessment; however, the difference between the two groups was similar to that observed by others.
In general, knowledge about mesh complications should be based on long-term follow-up. We believe that our study adds further important information: coating of the polypropylene mesh does not seem to offer any advantages, as it does not improve the success or mesh exposure rate reported for non-coated meshes. However, as this is the first report to consider the use of coated mesh, further studies are needed to clarify how such mesh interferes with the vaginal healing process and appearance of erosion. On the other hand, we think that the use of mesh in the anterior compartment is a safe procedure, judging by the small number of complications, and the minor complications may be justified in some primary cases. As there is no desire for repeat surgery in either group after a year, long-term follow-up is important in order to clarify whether the use of mesh in primary cases may reduce the need for further surgery in women undergoing vaginal repair for cystocele.
This work was not sponsored by any pharmaceutical company. None of the authors have any agreement with the industry related to the present publication.
All authors contributed to the protocol development, which was finalised by MR and PT All authors contributed to data collection. Data analysis was performed by UJ together with MR and PT The article was drafted by MR and PT, but all of the authors contributed to editing the article.
The study protocol was approved by the local ethics committee in each country: Denmark, ref. no. DK SJ-66 (approved by the local ethics committee of Sealand, 23 April 2008); Sweden, ref. no. Dnr 45/2008 (approved by the regional ethics committee of Lund, 14 February 2008); Norway, ref. no. 08/263 (ethics committee of Norway, approved 8 August 2008); and Finland, ref. no. KA22.2.2008 (approved by the south-west ethics committee of Finland; 19 February 2008). The trial was registered at ClinicalTrials.gov (NCT00627549): http://clinicaltrials.gov/ct2/show/NCT00774215. Disclosure forms were signed by each author.
This study was initiated and performed without support from industry. The study was funded by the Region Sealand Health research fund.
We thank Ulla Hviid (Department of Obstetrics and Gynaecology, Roskilde University Hospital, Denmark), Marianne Ottesen Weincke and Monica Topp (Department of Obstetrics and Gynaecology, Hvidovre University Hospital, Denmark), and Arne Urnæs (Department of Obstetrics and Gynaecology, Ahus University Hospital, Norway) for their help in recruiting study participants and their support during the study period (The Nordic Mesh Group).
With increased scrutiny by the US Food and Drug Administration (FDA), UK Medicines and Healthcare Products Regulatory Agency (MHRA), and other national regulatory agencies, the role of transvaginal mesh in the management of pelvic organ prolapse has become the subject of much controversy. The trial by Rudnicki et al. is consistent with the current literature on this subject: mesh augmentation provides an anatomical benefit over native tissue repairs for anterior vaginal prolapse (Maher et al., Cochrane Database Syst Rev 2013;4:CD004014). However, this benefit has not always resulted in a difference in symptomatic outcomes or reduced the rate of reoperation. No study, including this one, has demonstrated that mesh augmentation improves quality of life (QOL) more than non-mesh repair, in spite of superior anatomical outcomes. Moreover, the average mesh erosion rate is 11.4% in published trials (13.3% in this one), and the rate of reoperation for either prolapse recurrence or complications is higher after transvaginal mesh. This has led many national societies and regulatory bodies to advocate judicious use of transvaginal mesh by trained surgeons in carefully selected patients, with long-term surveillance through national surgical registries.
Rudnicki et al. compared anterior colporrhaphy with a collagen-coated polypropylene transvaginal mesh kit. In theory, this collagen coating is supposed to reduce the risk of mesh complications such as erosions. Unfortunately, neither this trial nor others directly test this theory, so it remains unknown if collagen coating provides any advantage or disadvantage over uncoated polypropylene mesh. Notably, however, this product is no longer commercially available. This trial benefitted from its multicentre design and use of validated outcome measures; however, its principal limitation is the choice of the primary outcome. Rudnicki et al. defined success as anterior support of POP–Q stages 0 or 1. Although this criteria has been commonly used, it is increasingly clear that it is too strict and is not likely to be clinically relevant. In the general population, 40% of women attending annual gynaecological examinations have vaginal support of stage 2 or greater, and would have been considered failures by this definition (Swift et al., Am J Obstet Gynecol 2005;192:795–806). Prolapse beyond the hymen appears to be a more clinically relevant threshold for anatomic success. More importantly, vaginal anatomy after surgery correlates poorly with a patient's perception of treatment success or QOL improvement (Barber et al., Obstet Gynecol 2009;114:600–609). Symptomatic relief is what is important to patients, not vaginal anatomy. Like most trials evaluating transvaginal mesh, no benefit in patient-reported outcomes or QOL was noted with the use of mesh in this study. Few studies on this topic follow patients beyond 1 year, so it is unknown if the anatomic benefits seen with transvaginal mesh at 1 year will eventually result in improvements that are clinically relevant in the long term (i.e. decreased symptom recurrence or fewer reoperations). As important, it is unknown what the cumulative rate of complications is over the remainder of a patient's life after mesh implantation. Large clinical trials and surgical registries that follow patients over many years and assess clinically relevant outcomes are necessary to truly understand the relative benefits and risks of transvaginal mesh placement for pelvic organ prolapse.
I have no conflicts of interest to declare.
Obstetrics, Gynecology and Women's Health Institute, Cleveland Clinic, Cleveland, OH, USA