Urinary and sexual impact of pelvic reconstructive surgery for genital prolapse by surgical route. A randomized controlled trial View Full Text


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Article Info

DATE

2022-01-19

AUTHORS

Renaud de Tayrac, Michel Cosson, Laure Panel, Clara Compan, Mohammed Zakarya Zemmache, Sophie Bouvet, Laurent Wagner, Brigitte Fatton, Géry Lamblin

ABSTRACT

Introduction and hypothesisThe main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.MethodsA prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4–8 weeks and 11–13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.ResultsOf the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22–4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia “usually or always” were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).ConclusionsBothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size. More... »

PAGES

2021-2030

References to SciGraph publications

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  • 2020-06-17. Pelvic organ prolapse and sexual function in NATURE REVIEWS UROLOGY
  • 2015-02-21. New onset stress urinary incontinence following laparoscopic sacrocolpopexy and its relation to anatomical outcomes in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2021-01-05. French validation of the Pelvic Organ Prolapse/Incontinence Sexual Questionnaire-IUGA revised (PISQ-IR) in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2018-07-09. Anatomical outcomes 1 year after pelvic organ prolapse surgery in patients with and without a uterus at a high risk of recurrence: a randomised controlled trial comparing laparoscopic sacrocolpopexy/cervicopexy and anterior vaginal mesh in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2012-07-24. Incidence and risk factors of postoperative stress urinary incontinence following laparoscopic sacrocolpopexy in patients with negative preoperative prolapse reduction stress testing in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2015-05-31. Utero-vaginal suspension using bilateral vaginal anterior sacrospinous fixation with mesh: intermediate results of a cohort study in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2017-06-15. Evidence to justify retention of transvaginal mesh: comparison between laparoscopic sacral colpopexy and transvaginal Elevate™ mesh in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2014-03-20. Is de novo stress incontinence after sacrocolpopexy related to anatomical changes and surgical approach? in INTERNATIONAL UROGYNECOLOGY JOURNAL
  • 2016-02-13. Pelvic organ prolapse repair using the Uphold™ Vaginal Support System: a 1-year multicenter study in INTERNATIONAL UROGYNECOLOGY JOURNAL
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    http://scigraph.springernature.com/pub.10.1007/s00192-021-05071-8

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    http://dx.doi.org/10.1007/s00192-021-05071-8

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    27 schema:description Introduction and hypothesisThe main objective of the study was to evaluate the rates of de novo stress urinary (SUI) and postoperative dyspareunia after both sacrocolpopexy/hysteropexy (SCP) and vaginal mesh surgery.MethodsA prospective, multicenter, randomized, open-label study with two parallel groups treated by either SCP or Uphold Lite vaginal mesh was carried out. Study participants were ≥ 50 and < 80 years old patients with Pelvic Organ Prolapse Quantification (POP-Q) stage ≥2 who were considered eligible for reconstructive surgery and who were sexually active with no dyspareunia and free from bothersome SUI at presentation. Women were assessed before surgery and at 4–8 weeks and 11–13 months after using validated measures including POP-Q, Pelvic Floor Disability Index (PFDI-20), Pelvic Floor Impact Questionnaire (PFIQ-7), Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire, IUGA-Revised (PISQ-IR), and Patient Global Impression of Improvement (PGI-I). Data were also collected for health economics evaluation.ResultsOf the required sample of 156 women, 42 women (19 SCP and 23 vaginal mesh) were only recruited owing to the discontinuation of vaginal mesh worldwide. The median follow-up was 376 days. The rates of bothersome de novo SUI were similar in the SCP and Uphold vaginal mesh groups (15.79 vs 15.00%, OR 0.95 [95% CI 0.22–4.14]). Among 30 sexually active patients at follow-up, the rates of women reporting de novo dyspareunia “usually or always” were 6.7% after SCP vs 13.3% after vaginal mesh (p = 1). Health economics evaluation showed a cost saving of 280€ in favor of the Uphold vaginal mesh technique, but no significant difference in the total cost (2,934.97€ for SCP vs 3,053.26€ for Uphold vaginal mesh).ConclusionsBothersome de novo SUI and de novo dyspareunia occurred in approximately 15% and 23% of our study cohorts, with no significant difference between sacrocolpopexy/hysteropexy and anterior/apical vaginal mesh surgery. However, these results should be interpreted with caution owing to the small sample size.
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    34 Global Impression
    35 IUGA-Revised
    36 Impact Questionnaire
    37 MethodsA
    38 Patient Global Impression
    39 Pelvic Floor Disability Index
    40 Pelvic Floor Impact Questionnaire
    41 Pelvic Organ Prolapse Quantification stage
    42 Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire
    43 Prolapse/Urinary Incontinence Sexual Questionnaire
    44 ResultsOf
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    46 active patients
    47 caution
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    54 differences
    55 discontinuation
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    57 economic evaluation
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    63 hysteropexy
    64 impact
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    67 index
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    69 main objective
    70 measures
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    75 months
    76 multicenter
    77 novo dyspareunia
    78 objective
    79 older patients
    80 open-label study
    81 parallel group
    82 participants
    83 patients
    84 pelvic reconstructive surgery
    85 pop
    86 postoperative dyspareunia
    87 presentation
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    91 rate
    92 rate of women
    93 reconstructive surgery
    94 results
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