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A prospective, randomized, controlled study comparing Gynemesh®, a synthetic mesh, and Pelvicol®, a biologic graft, in the surgical treatment of recurrent cystocele

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Abstract

We compared safety and efficacy of Gynemesh PS® and Pelvicol® for recurrent cystocele repair. One hundred ninety patients were randomly divided into Gynemesh PS® and Pelvicol® groups and underwent tension-free cystocele repair. The Chi-square test was used to compare categorical variables, the paired t test for continuous parametric variables, and the Mann–Whitney test for continuous nonparametric variables. Ninety-six Gynemesh PS® patients and 94 Pelvicol® patients were studied. Mesh erosions occurred in 6.3% of Gynemesh PS® patients. No erosions were observed in Pelvicol® patients (p = 0.02). Objective cure was 71.9% for Gynemesh PS® and 56.4% for Pelvicol® (p = 0.06). Subjective cure was the same in both groups except for better sexuality in the Pelvicol® group. At 24 months follow-up, only Gynemesh PS® patients had mesh erosions. Anatomical outcome was similar in the two groups. Pelvicol® gave a better impact on voiding and sexuality.

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Abbreviations

LM:

levator myorrhaphy

POP:

pelvic organ prolapse

POP-Q:

pelvic organ prolapse quantification

PISQ-12:

Pelvic Organ Prolapse–Urinary Incontinence Sexual Questionnaire

TCR:

tension-free cystocele repair

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Authors and Affiliations

  1. Department of Urogynecology, S. Carlo-IDI Hospital, Rome, Italy

    F. Natale, M. Agostini, E. De Simone & M. Cervigni

  2. Section of Gynecology and Obstetrics, Department of Surgery, University of Rome “Tor Vergata”, Rome, Italy

    C. La Penna

  3. Department of Obstetrics and Gynecology, Assaf Harofe Medical Center, Tel Aviv University, Tel Aviv, Israel

    A. Padoa

Authors
  1. F. Natale
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  2. C. La Penna
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  3. A. Padoa
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  4. M. Agostini
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  5. E. De Simone
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  6. M. Cervigni
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Correspondence to F. Natale.

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Natale, F., La Penna, C., Padoa, A. et al. A prospective, randomized, controlled study comparing Gynemesh®, a synthetic mesh, and Pelvicol®, a biologic graft, in the surgical treatment of recurrent cystocele. Int Urogynecol J 20, 75–81 (2009). https://doi.org/10.1007/s00192-008-0732-6

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  • DOI: https://doi.org/10.1007/s00192-008-0732-6

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