To our knowledge, this is the first study of considerable size that prospectively and specifically evaluates the efficacy and safety of the total tension-free vaginal mesh repair using one continuous piece of polypropylene mesh for all three compartments of the prolapsed vaginal vault. The Prolift™ total prolapse repair system is unique in this respect, and at present, the only available surgical kit that offers the possibility of such a comprehensive repair. It aims at support of the weakened vaginal walls of the anterior and posterior compartments and suspension of the apical compartment by means of a bilateral sacrospinous ligament fixation thus restoring Delancey level I support [
15]. Other mesh kits are designed to treat the anterior and posterior compartments, either alone or simultaneously, with a separate (split) mesh. Suspension of the vault in these procedures is not achieved by a bilateral sacrospinous ligament fixation, but by means of bilateral infracoccygeal sacropexy as described by Petros [
16]. Most data on these procedures are derived from congress abstracts, retrospective reports, or studies with short follow-up [
7,
9,
17]. Only a few data are published with a medium long-term follow-up, but none of these focuses exclusively on the total repair with one continuous piece of mesh [
8,
10].
Anatomical effect
Considering the high percentage of patients with recurrent prolapse (98%) and high stage POP (III and IV) in this study group at baseline (87%) and the follow-up period of 1 year, the overall anatomical success of 91% is respectable. This is also reflected in the mean changes of the three most relevant POP-Q variables (Ba, C, and Bp) between baseline and 12 months, which even exceed those reported by other authors [
8]. Anatomical success rates per compartment are comparable with that report.
Anatomical results in this study seem more promising than those reported by the Scandinavian group, who reported 79–82% for the anterior compartment and 81–86% for the posterior compartment [
10]. Neither of these authors, however, makes a distinction between the combined anterior and posterior mesh treatment and one with a continuous piece of mesh. A clear comparison is therefore not possible. The Scandinavian group reported the combined results of 26 participating centres, while we report on only two major centres. Therefore, the number of procedures performed per surgeon and possibly the experience related to this might be different. Only one other minor study reported on 21 Prolift™ total repairs with a continuous piece of mesh and showed an anatomical success of 87% at 12 months [
18]. The fairly small number of patients evaluated in that study makes 95% CI rather wide (14%) and results less comparable.
The success rate of 95% for restoration of level I support of the apex is comparable with the 74–100% success rate of apical support in abdominal sacrocolpopexy and the 89–97% success rate for restoration of apical support by sacrospinous ligament fixation [
19‐
21]. The advantage of this total vaginal mesh procedure, however, is that it adds support to both other vaginal compartments as well, and compared to the abdominal sacrocolpopexy, has a shorter operation time and can be considered as relatively minimally invasive treatment.
At 12 months, the measured total vaginal length was a mean 0.3-cm shorter than at baseline. This slight shortening probably is due to some shrinkage of the mesh, which actually is not a shrinkage of the material itself but rather a retraction because of fibrotic reactions to the polypropylene mesh [
22]. Although this slight shortening is statistically significant, we, as other authors, could not detect any clinical significance to this finding [
10]. If shrinkage continues, however, this could become relevant in the future, so, longer follow-up is mandatory.
Mesh exposure
One important adverse effect of mesh surgery is the fairly high number of mesh exposures. We found seven (15%) after 12 months. Interestingly, we found none at the first postoperative visit at 6 weeks, but four at 6 months, and another three at the 12-month visit. Neither of these patients was symptomatic. Therefore, a very careful follow-up even beyond 12 months seems mandatory. The number of exposures in the remaining 150 patients of our database who completed their 12-month follow-up (at present data are being processed) is 10% and not statistically significant different from the percentage in this series (Pearson’s chi-square 1.067;
p = 0.301). The Scandinavian group reported similar findings: the erosion percentage rose from 7% at 2 months to 11% at 12 months [
10]. A similar percentage (11.3%) is also reported in the large retrospective French series [
23]. Since we are not aware of the natural development of these most asymptomatic mesh erosions, we felt the urge to treat them, initially with topical estrogens, but as this was not sufficient in most cases, we performed a minor mesh excision in five (11%) patients. The remaining two patients who preferred expectant management are still symptom-free.
Of these seven patients with a tiny mesh exposure, four didn’t have intercourse at baseline, but one of these had resumed intercourse at 6 months. One other patient continued to have intercourse. Neither of both complained of dyspareunia. Of three patients in whom a mesh exposure was detected at the 12-month visit, two had intercourse at baseline. At 12 months, one of these continued to have intercourse without symptomatic dyspareunia, and the other patient had abstained from intercourse for other reasons than pain. Apparently, sexual intercourse in these patients was not hindered by the presence of these minor mesh exposures.
We found that the mean duration of surgery in the group of patients who developed a mesh exposure (92 ± 13) was 14 min longer than in those who did not (78 ± 15). Whether this is a significant item in this relatively small group of patients remains unclear. This study, however, represents a fairly complex group of patients with recurrent prolapse in all but one case. The special technique which leaves a small bridge of vaginal vault intact may jeopardise the vascularisation of the vaginal tissue and could be responsible for poor wound healing and, thus, mesh exposure. In our opinion, the rate of mesh exposures is still too high, and determinants other than those already published need to be discovered to lower this incidence [
23‐
25].
Functional effects
Some earlier studies warned of the use of synthetic mesh in prolapse surgery because of a high risk of dyspareunia [
26]. Other authors, who used modern kits with low-weight polypropylene designed by other companies, such as coated polypropylene (Ugytex, Sofradim, France) or the Perigee transobturator prolapse repair system (American Medical Systems, Minnetonka, MN, USA), reported de novo dyspareunia after 1 year in 13% and 9% of patients, respectively [
27,
28]. We detected de novo dyspareunia in two out of eleven patients (18%), but these are small numbers. On the other hand, the percentages of patients having intercourse or dyspareunia at baseline and 12 months were practically identical. In two out of seven patients (28%) who suffered from dyspareunia at baseline, this complaint was no longer present at 12 months. Furthermore, three out of 23 patients (13%) who were not having intercourse at baseline had resumed this at 12 months. These data show that prolapse itself is a cause of dyspareunia and prolapse repair, in this case, with a fairly large synthetic mesh, is able to resolve this problem in some cases. These results are comparable with observations done by the Scandinavian group, who used the short form of the pelvic organ prolapse/urinary incontinence sexual function questionnaire [
29]. They observed an overall deterioration of sexual function scores in women 1 year after trocar-guided transvaginal mesh surgery. However, the worsening was attributed to decreased scores on behavioural-emotive and partner-related items, such as partner inability to obtain erection. Dyspareunia neither improved, nor worsened, as is our observation [
30]. Although the rate of de novo dyspareunia seems low with the present light-weight meshes, we should remain cautious and await longer-term follow-up for realistic interpretations.
From a patients’ point of view, a subjective improvement in experienced bother and quality of life is probably more important than the objective anatomical success. This is clearly shown by the stable percentage of patients (93%) that experienced their situation to be much better to very much better, 12 months after surgery than at baseline. The improvements in the various domains of UDI, DDI, and IIQ remain stable between 6 and 12 months and are highly significant compared to baseline, except for the domains of incontinence of the UDI and constipation, pain and incontinence of the DDI, and embarrassment of the IIQ. As mentioned before, so far, it has been our strategy not to treat patients simultaneously for their prolapse and potentially manifest or masked stress urinary incontinence. All patients were counselled about this strategy before surgery. Only one patient needed and underwent a mid-urethral sling procedure between her 6- and 12-month visits because of unmasked stress urinary incontinence.
In our opinion, the strengths of this study are its prospective nature and the use of internationally accepted instruments of measurement such as validated questionnaires and POP-Q, the follow-up period of 1 year, as well as the high follow-up rate and data acquisition in all patients. A limitation of this study on the other hand is that not all POP-Q measurements were performed by an independent examiner.
Conclusion
The trocar-guided total tension-free vaginal mesh repair for post-hysterectomy vaginal vault prolapse with one continuous piece of polypropylene mesh is very well tolerated and both anatomically and functionally highly effective at 6 and 12 months follow-up. Whether this procedure is more effective and safe than other forms of prolapse surgery remains to be determined in randomised controlled trials.