Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study
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Introduction and hypothesis
The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System.
We carried out a 1-year, multicenter, prospective, single cohort study of 207 women with symptomatic Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 apical pelvic organ prolapse, with or without concomitant anterior vaginal wall prolapse. Safety data were collected using a standardized questionnaire. Anatomical outcome was assessed by the POP-Q and subjective outcomes by the Pelvic Floor Distress Inventory after 2 months and 1 year using a one-way repeated measures analysis of variance. Pain was evaluated using a visual analog scale.
The overall rate of serious complications was 4.3 % (9 out of 207 patients), including 3 patients with bladder perforations, 1 with bleeding >1,000 ml, 2 who had undergone re-operations with complete mesh removal because of pain, and 3 surgical interventions during follow-up because of mesh exposure. POP-Q stage ≤1 after 1 year was 94 % and subjective symptom relief was reported by 91 % of patients (p < 0.001). Pain after 2 months and 1 year was 60 % lower compared with the preoperative mean (p < 0.001). Minor complications occurred in 20 women (9.7 %) and were dominated by lower urinary tract dysfunction. No predisposing risk factors for complications were found.
The Uphold™ Lite procedure in women with apical pelvic organ prolapse provided satisfactory restoration of vaginal topography and symptom relief. However, serious complication rates were largely comparable with those of other transvaginal mesh kits.
KeywordsComplications Mesh Pelvic organ prolapse
Compliance with ethical standards
The study was supported by an investigator-initiated grant from Boston Scientific and grants from the Finnish Medical Foundation and the Swedish Scientific Council.
Conflicts of interest
P. Rahkola-Soisalo, T.S. Mikkola, K. Möller-Bek, and M. Ellström Engh report no conflicts of interest. D. Altman has received speaking and advisory honoraria from Gedeon Richter, Pfizer, Astellas, Invent Medic and Gynecare. C. Falconer has received speaking and advisory honoraria from Boston Scientific and Johnson & Johnson. J. Gunnarsson has received speaking and advisory honoraria from Gedeon Richter.
- 3.FDA (2011) Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNOtices/ucm262435.htm
- 4.De Tayrac R, Sentilhes L (2013) Complications of pelvic organ prolapse surgery and methods of prevention. Int Urogynecol J 24:1859–1872Google Scholar
- 8.Van Raalte HM, Lucente VR, Molden SM, Haff R, Murphy M (2008) One-year anatomic and quality-of-life outcomes after the Prolift procedure for treatment of posthysterectomy prolapse. Am J Obstet Gynecol 199:694.e1–694.e6Google Scholar
- 10.Khan ZA, Thomas L, Emery SJ (2014) Outcomes and complications of trans-vaginal mesh repair using the Prolift kit for pelvic organ prolapse at 4 years median follow-up in a tertiary referral centre. Arch Gynecol Obstet 290:1155–1157Google Scholar
- 15.Van der Ploeg JM, van der Steen A, Oude Rengerink K, van der Vaart CH, Roovers JP (2014) Prolapse surgery with or without stress incontinence surgery for pelvic organ prolapse: a systematic review and meta-analysis of randomised trials. BJOG 121:537–547Google Scholar