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Efficacy and safety of Mesh-augmented transvaginal repair with Calistar S in non-fertile women with recurrent or complex anterior pelvic organ prolapse according to the SCENIHR recommendations on urogynecological surgical meshes
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Veröffentlicht: | 4. November 2021 |
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Introduction: The utilization of synthetic implants in POP repair became increasingly popular in the last decade due to high failure rates of native tissue repair. However, meshes for POP repair have been recently scrutinized due to adverse events which raised concerns of the patients’ safety. Progress in the development of reduced mesh densities, the utilization of macroporous mesh structure, the performance of the procedure by experienced surgeons and thorough patients selection are established factors which significantly reduce the rate of these adverse events.
The risk-benefit rationale for transvaginal POP repair with synthetic implants has been critically reviewed by the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR); concluding, that in a selected patient population, the benefits of transvaginal mesh repair still outweigh the risks. This patient population is limited to women with complex primary POP, thus of high risk for recurrence, and recurrent POP. The current investigation evaluated transvaginal mesh-augmented repair with the ultra-lightweight mesh Calistar S (Promedon, Argentina) in women with recurrent or complex anterior POP prolapse with or without apical vaginal wall involvement.
Methods: Women who underwent transvaginal POP repair with Calistar S for either recurrent or complex anterior POP have been included in this multicenter cohort trial after approval of the local ethics committee (Number 60750/2019/99). Baseline characteristics and perioperative assessment have been evaluated retrospectively. Prospective assessment of treatment success and complications have been performed by a clinical appointment for vaginal examination and medical history. Treatment success was defined by a composite endpoint including anatomical (anterior and apical POP-Q<1) and subjective (absence of a vaginal bulge symptom) components, as well as the necessity for a repeated surgery due to anterior or apical POP recurrence. Validated questionnaires have been utilized to evaluate Quality of life and POP symptoms. Descriptive statistics has been applied. Time-dependent variables are presented using Kaplan-Meier curves. McNemar or Wilcoxon signed rank tests were used as paired samples tests. The significance level was set at 5%.
Results: There were a total of 107 women with either recurrent [n=93 (86.9%)] or complex primary POP [n=14 (13.1%)], respectively. The mean age was 70.6 years (SD 7.7). The mean operation time was 37.7 (SD 17.3) minutes. There were no intraoperative complications. Mean follow-up time was 18.5 months.
Treatment success according to the primary composite endpoint was achieved in 76 (76.0 %) patients. Anatomic cure defined by POP-Q≤1 was 98 % (Figure 1 [Fig. 1]) and no women required repeated surgery for anterior or apical POP. Quality-of-life improved significantly relative to baseline (p<0.001, Figure 2 [Fig. 2]) as well as the domain prolapse symptoms (p<0.001) according the validated German POP-Questionnaire. Furthermore, 99 (91.7%) women satisfied with the operation.
Vaginal exposure occurred in 6 (5.6%) patients. However, all exposures were treated either expectantly or with vaginal estrogen therapy. None of the erosions required further surgery at the time of last follow-up. The estimated exposure-free rate was 93 % after 20 months. One patient (0.9 %) required further surgery due to folding without epithelial separation. Trimming of the mesh was performed during concomitant implantation of a retropubic midurethral sling. Four (3.7 %) women had persistent residual urine or urinary retention that required intermittent catheterization.
Conclusion: Considering the SCENIHR recommendations for a suitable mesh implant, adequate patient selection and surgeon experience in transvaginal pelvic floor reconstruction, our study demonstrates that mesh-augmented transvaginal repair with Calistar S is an effective and safe option in women with recurrent or primary complex anterior POP. Although the majority of our patients had recurrent prolapses, success rates remained high and re-intervention rates for recurrence or adverse events were deniable in this select population.
Conflict of interest: C. Mörgeli and A. Kolterer declare that they have no conflict of interest. G. Naumann declares participation in clinical trials and consultancy for Promedon, Member of Advisory Board at Dr. Pfleger GmbH. R. Tunn declares participation in clinical trials and consultancy for Promedon, patent and license fee from FA Viomed. T. Hüsch declares employment at Promedon GmbH.