Abstract
Introduction and hypothesis
To evaluate clinical effectiveness and complication rates at 5 years following the total Trans Vaginal Mesh (TVM) technique to treat pelvic organ prolapse.
Methods
Prospective, observational, multi-centre study in patients with prolapse of stage II or higher.
Results
Of the 90 women enrolled in the study, 82 (91 %) were available for the 5-year follow-up period. At the 5-year endpoint, success, defined as no surgical prolapse reintervention and leading edge <−1 (International Continence Society [ICS] criteria) or above the level of the hymen, was 79 % and 87 % respectively. A composite criterion of success defined as: leading edge above the hymen (<0) and no bulge symptoms and no reintervention for prolapse was met by 90 %, 88 % and 84 % at the 1-, 3-, and 5-year endpoints respectively. Quality of life improvement was sustained over the 5 years. Over the 5-year follow-up period, a total of only 4 patients (5 %) required re-intervention for prolapse, while a total of 14 patients (16 %) experienced mesh exposure for which 8 resections needed to be performed. Seven exposures were still ongoing at the 5-year endpoint, all asymptomatic. Only 33 out of 61 (54 %) sexually active patients at baseline remained so at 5 years. De novo dyspareunia was reported by 10 %, but no new cases at the 5-year endpoint. One patient reported de novo unprovoked mild pelvic pain at 5 years, 5 reported pains during pelvic examination only.
Conclusions
Five-year results indicated that TVM provided a stable anatomical repair. Improvements in QOL and associated improvements in prolapse-specific symptoms were sustained. Minimal new morbidity emerged between the 1- and 5-year follow-up.
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Abbreviations
- BMI:
-
Body mass index
- ICS:
-
International Continence Society
- LOCF:
-
Last observation carried forward
- POP:
-
Pelvic organ prolapse
- POP-Q:
-
Pelvic organ prolapse quantification
- PSI:
-
Prolapse-specific inventory
- QOL:
-
Quality of life
- SD:
-
Standard deviation
- SUI:
-
Stress urinary incontinence
- TVM:
-
Transvaginal mesh
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Ethicon.
Conflicts of interest
Bernard Jacquetin holds the patent for Prolift® for which he receives royalties from Ethicon. B. Jacquetin, P. Debodinance, C. Rosenthal and M. Cosson have all held consultancy positions for Ethicon. B. Jacquetin, H. Clavé, M. Cosson and P. Debodinance have all accepted payment of travel expenses or honoraria from Ethicon. M. Cosson and P. Debodinance have all had acceptance of payment for research. P. Hinoul and J. Gauld are employed by Ethicon. D. Salet-Lizée, R. Villet, J. Berrocal, B. Fatton and O. Garbin: no financial disclosures regarding Ethicon.
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Jacquetin, B., Hinoul, P., Gauld, J. et al. Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study. Int Urogynecol J 24, 1679–1686 (2013). https://doi.org/10.1007/s00192-013-2080-4
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DOI: https://doi.org/10.1007/s00192-013-2080-4