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Prospective multicenter trial assessing type I, polypropylene mesh placed via transobturator route for the treatment of anterior vaginal prolapse with 2-year follow-up

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Abstract

Introduction and hypothesis

Two-year outcomes of treating cystocele with a polypropylene mesh (Perigee System® with IntePro®, AMS, Inc.) placed via a transobturator approach are reported.

Methods

A prospective, multicenter trial was conducted evaluating 114 women with ≥ stage II anterior wall prolapse defined using International Continence Society guidelines. Treatment success was defined as anterior stage ≤ I at a 24-month follow-up. Quality of life questionnaires were administered at baseline and follow-up. Complications were reported via adverse events.

Results

Efficacy at 24 months was 88.5% (77/87). Pelvic floor distress inventory, pelvic floor impact questionnaire-7, and pelvic organ prolapse/urinary incontinence sexual questionnaire were all significantly improved from baseline (p < 0.001). Complication rates reported were vaginal mesh extrusion 10.5% (12/114) and groin, pelvic, or vaginal pain 4.4% (5/114). Six subjects reported de novo dyspareunia. Out of the 49 subjects reporting dyspareunia at baseline, 15 were resolved postoperatively.

Conclusions

The Perigee System is an effective treatment to repair anterior wall prolapse with a low rate of complications through a 2-year follow-up.

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Abbreviations

AMS:

American Medical Systems, Inc., Minnetonka, MN, USA

AE:

Adverse event

POP:

Pelvic organ prolapse

POP-Q:

Pelvic organ prolapse quantification system

QOL:

Quality of life

PFDI:

Pelvic floor distress inventory

PFIQ-7:

Pelvic floor impact questionnaire-7

PISQ-12:

Pelvic organ prolapse/urinary incontinence sexual questionnaire

IRB:

Institutional Review Board

TOT:

Transobturator tape in the treatment of female stress urinary incontinence

TVT:

Tension-free vaginal tape in the treatment of female stress urinary incontinence

f/u:

Follow-up

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Conflicts of interest

This study was sponsored by American Medical Systems Inc., Minnetonka, MN, USA.

Author information

Authors and Affiliations

  1. Advanced Pelvic Surgery and Urogynecology, Atlanta Urogynecology Associates, 3400C Old Milton Parkway, Atlanta, GA, 30005, USA

    Robert D. Moore

  2. Department of Gynecology, Women’s Health Care Specialists, Paw Paw, MI, USA

    Roger D. Beyer

  3. Department of Urology, Integrity Medical Research, Mountlake Terrace, WA, USA

    Karny Jacoby

  4. Department of Urology/Gynecology, Sheldon Freedman, M.D. LTD, Las Vegas, NV, USA

    Sheldon J. Freedman

  5. Department of Urology, Eastern Virginia Medical School, Norfolk, VA, USA

    Kurt A. McCammon

  6. Department of Urology, Columbus Urology LLC, Columbus, OH, USA

    Mike T. Gambla

Authors
  1. Robert D. Moore
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  2. Roger D. Beyer
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  3. Karny Jacoby
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  4. Sheldon J. Freedman
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  5. Kurt A. McCammon
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  6. Mike T. Gambla
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Corresponding author

Correspondence to Robert D. Moore.

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Moore, R.D., Beyer, R.D., Jacoby, K. et al. Prospective multicenter trial assessing type I, polypropylene mesh placed via transobturator route for the treatment of anterior vaginal prolapse with 2-year follow-up. Int Urogynecol J 21, 545–552 (2010). https://doi.org/10.1007/s00192-009-1071-y

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  • DOI: https://doi.org/10.1007/s00192-009-1071-y

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