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International Urogynecology Journal

, Volume 27, Issue 9, pp 1337–1345 | Cite as

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

  • Daniel Altman
  • Tomi S. Mikkola
  • Karl Möller Bek
  • Päivi Rahkola-Soisalo
  • Jonas Gunnarsson
  • Marie Ellström Engh
  • Christian Falconer
  • For the Nordic TVM group
Original Article

Abstract

Introduction and hypothesis

The objective was to assess safety and clinical outcomes in women operated on using the Uphold™ Lite Vaginal Support System.

Methods

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.

Results

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.

Conclusions

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.

Keywords

Complications Mesh Pelvic organ prolapse 

Notes

Compliance with ethical standards

Funding

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.

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Copyright information

© The International Urogynecological Association 2016

Authors and Affiliations

  • Daniel Altman
    • 1
    • 2
  • Tomi S. Mikkola
    • 3
    • 4
  • Karl Möller Bek
    • 5
  • Päivi Rahkola-Soisalo
    • 3
  • Jonas Gunnarsson
    • 6
  • Marie Ellström Engh
    • 7
  • Christian Falconer
    • 2
  • For the Nordic TVM group
  1. 1.Stockholm Urogynecological ClinicStockholmSweden
  2. 2.Department of Obstetrics and GynecologyDanderyd HospitalDanderydSweden
  3. 3.Department of Obstetrics and Gynecology University of Helsinki and Helsinki University Central HospitalHelsinkiFinland
  4. 4.Folkhälsan Research centerHelsinkiFinland
  5. 5.Aarhus University HospitalAarhusDenmark
  6. 6.Department of Obstetrics and GynecologySahlgrenska University HospitalGöteborgSweden
  7. 7.Department of Obstetrics and GynaecologyAkershus University HospitalLørenskogNorway

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