International Urogynecology Journal

, Volume 23, Issue 4, pp 487–493

Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device

  • T. Sayer
  • J. Lim
  • J. M. Gauld
  • P. Hinoul
  • P. Jones
  • N. Franco
  • D. Van Drie
  • M. Slack
  • for the Prosima Study Investigators
Original Article

DOI: 10.1007/s00192-011-1600-3

Cite this article as:
Sayer, T., Lim, J., Gauld, J.M. et al. Int Urogynecol J (2012) 23: 487. doi:10.1007/s00192-011-1600-3

Abstract

Introduction and hypothesis

This study was designed to evaluate clinical outcomes ≥2 years following surgery with polypropylene mesh and vaginal support device (VSD) in women with vaginal prolapse, in a prospective, multi-center setting.

Methods

Patients re-consented for this extended follow-up (n = 110), with anatomic evaluation using Pelvic Organ Prolapse Quantification (POP-Q) and validated questionnaires to assess pelvic symptoms and sexual function. Complications were recorded (safety set; n = 121).

Results

Median length of follow-up was 29 months (range 24–34 months). The primary anatomic success, defined as POP-Q 0–I, was 69.1%; however, in 84.5% of the cases, the leading vaginal edge was above the hymen. Pelvic symptoms and sexual function improved significantly from baseline (p < 0.01). Mesh exposure rate was 9.1%. Five percent reported stress urinary incontinence and 3.3% required further prolapse surgery.

Conclusion

These results indicate this non-anchored mesh repair is a safe and effective treatment for women with symptomatic vaginal prolapse in the medium term.

Keywords

Pelvic organ prolapsePolypropylene meshVaginal surgeryVaginal support device

Abbreviations

CI

Confidence interval

DRI

Device run-in

ICS POP-Q

International Continence Society Pelvic Organ Prolapse Quantification

PGI-C

Patient Global Impression of Change

PFDI-20

Pelvic Floor Distress Inventory

PFIQ-7

Pelvic Floor Impact Questionnaire

PISQ-12

Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire

QoL

Quality of life

SD

Standard deviation

US

United States

VSD

Vaginal support device

Copyright information

© The International Urogynecological Association 2011

Authors and Affiliations

  • T. Sayer
    • 1
  • J. Lim
    • 2
  • J. M. Gauld
    • 3
  • P. Hinoul
    • 4
  • P. Jones
    • 3
  • N. Franco
    • 5
  • D. Van Drie
    • 6
  • M. Slack
    • 7
  • for the Prosima Study Investigators
  1. 1.North Hampshire HospitalBasingstokeUK
  2. 2.Royal Women’s HospitalMelbourneAustralia
  3. 3.Clinical Development, EthiconLivingstonUK
  4. 4.Medical Affairs, Ethicon, SomervilleNew JerseyUSA
  5. 5.Specialists in UrologyNaplesUSA
  6. 6.Women’s Health Center of West MichiganGrand RapidsUSA
  7. 7.Addenbrooke’s HospitalCambridgeUK