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


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.


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).


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.


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


Pelvic organ prolapse Polypropylene mesh Vaginal surgery Vaginal support device 



Confidence interval


Device run-in


International Continence Society Pelvic Organ Prolapse Quantification


Patient Global Impression of Change


Pelvic Floor Distress Inventory


Pelvic Floor Impact Questionnaire


Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire


Quality of life


Standard deviation


United States


Vaginal support device


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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

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