Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study.

Abstract

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 2months and 1year 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 >1,000ml, 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 1year was 94% and subjective symptom relief was reported by 91% of patients (p < 0.001). Pain after 2months and 1year 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.