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

Authors

  • T. Sayer
    • North Hampshire Hospital
    • Royal Women’s Hospital
  • J. M. Gauld
    • Clinical Development, Ethicon
  • P. Hinoul
    • Medical Affairs, Ethicon, Somerville
  • P. Jones
    • Clinical Development, Ethicon
  • N. Franco
    • Specialists in Urology
  • D. Van Drie
    • Women’s Health Center of West Michigan
  • M. Slack
    • Addenbrooke’s Hospital
  • 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