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

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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.

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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

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Acknowledgments

Investigators of the Prosima Study Group are Jeanette Lim, Melbourne, Australia; Nick Franco, Naples, FL; Christian Goepel, Halle, Germany; Miles Murphy, Allentown, PA; Salil Khandwala, Dearborn, MI; Christl Reisenauer, Tübingen, Germany; Tim Sayer, Basingstoke, UK; Mark Slack, Cambridge, UK; Tony Smith, Manchester, UK; Douglas VanDrie, Grand Rapids, MI; Halina Zyczynski, Pittsburgh, PA. Members of the Clinical Development team at Ethicon who contributed to study design and implementation and the analysis of data: David Robinson, MD (Medical Director); Patricia Beach, MBA, MA (Clinical Project Manager); Colin Urquhart, BSc (Clinical Project Manager); Chris McEleney (Data Manager); David Shah (Data Manager); Linda Lin, MS (Programmer); Ailie Smith, BSc (Quality Compliance Manager).

Conflicts of interest

T. Sayer, J. Lim, D. Van Drie, M. Slack and P. Jones all have consultancy positions with Ethicon. P. Hinoul and J. Gauld are employed by Ethicon.

Author information

Authors and Affiliations

  1. North Hampshire Hospital, Basingstoke, UK

    T. Sayer

  2. Royal Women’s Hospital, Melbourne, Australia

    J. Lim

  3. Clinical Development, Ethicon, Livingston, UK

    J. M. Gauld & P. Jones

  4. Medical Affairs, Ethicon, Somerville, New Jersey, USA

    P. Hinoul

  5. Specialists in Urology, Naples, FL, USA

    N. Franco

  6. Women’s Health Center of West Michigan, Grand Rapids, MI, USA

    D. Van Drie

  7. Addenbrooke’s Hospital, Cambridge, UK

    M. Slack

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  1. T. Sayer
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Correspondence to J. Lim.

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Sayer, T., Lim, J., Gauld, J.M. et al. Medium-term clinical outcomes following surgical repair for vaginal prolapse with tension-free mesh and vaginal support device. Int Urogynecol J 23, 487–493 (2012). https://doi.org/10.1007/s00192-011-1600-3

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  • DOI: https://doi.org/10.1007/s00192-011-1600-3

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