Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 5-year prospective follow-up study
- First Online:
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.
Prospective, observational, multi-centre study in patients with prolapse of stage II or higher.
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.
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.
KeywordsMesh Pelvic organ prolapse Polypropylene Prolift Transvaginal mesh Vaginal surgery
Body mass index
International Continence Society
Last observation carried forward
Pelvic organ prolapse
Pelvic organ prolapse quantification
Quality of life
Stress urinary incontinence
- 18.Jacquetin B, Fatton B, Rosenthal C, Clavé H, Debodinance P, Hinoul P, Gauld J, Garbin O, Berrocal J, Villet R, Salet Lizée D, Cosson M (2010) Total transvaginal mesh (TVM) technique for treatment of pelvic organ prolapse: a 3-year prospective follow-up study. Int Urogynecol J Pelvic Floor Dysfunct 21:1455–1462CrossRefGoogle Scholar
- 20.Kobashi KC, Gormley EA, Govier F, Hadley R, Luber K, Nitti V (2000) Development of a validated quality of life measurement for patients with pelvic prolapse. Proceedings of the American Urological Association 95th Annual Meeting. J Urol 163:76Google Scholar
- 24.FDA Safety communication: update on serious complications associated with transvaginal mesh placement of surgical mesh for pelvic organ prolapse, FDA, July 13, 2011 http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm262435.htm