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No mesh versus mesh in the treatment of anterior vaginal wall prolapse: prospective, randomised, controlled trial, long-term follow-up

  • Urology - Original Paper
  • Published:
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Abstract

Objectives

To compare the efficacy and safety of anterior colporrhaphy (AC) versus transvaginal polypropylene mesh (PM) for the treatment of anterior vaginal wall prolapse (AVWP) at long-term follow-up.

Methods

Prospective and randomized controlled trial, 100 women with AVWP stage ≥ II assessed by the Pelvic Organ Prolapse Quantification System (POP-Q) underwent AC (control group) or PM insertion (mesh group). At baseline and at 60-month follow-up, safety profile, anatomical outcomes by POP-Q measurements and staging, subjective outcomes and quality of life (QoL) impact by ICIQ (SF and VV) and OAB-V8 questionnaires were assessed

Results

76 women completed the study, 43 in Control versus 33 in Mesh group. Significant improvements were observed in all variables between the 2 times in each group (p < 0.0001), without differences between groups. Objective cure (POP-Q Ba ≤ − 2 and Ba ≤ − 1) occurred in 22 and 36 (51.2 and 83.7%) versus 23 and 31 (69.7 and 93.9%), p = 0.10 and 0.29; and subjective cure (VSS, no vaginal symptom) in 21 (48.8%) versus 17 (51.5%), p = 0.82, respectively, at 60-month follow-up. When adjusted for the other variables, Mesh group showed worse QoL impact due to subjective vaginal symptoms (odds ratio 3.99, CI 95% 1.13; 14.13). AVW asymptomatic mesh exposure occurred in 2 patients (6.06%) in the Mesh group.

Conclusions

AC and PM provided good overall objective and subjective outcomes for a minimum 60-month follow-up. Vaginal and urinary symptoms improved post-operatively in both groups. Mesh group experienced four times more negative impact on QoL compared to Control at 60-month follow-up.

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Funding

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Authors and Affiliations

  1. Department of Medicine, Federal University of Sao Carlos, São Carlos, SP, Brazil

    José Tadeu Nunes Tamanini

  2. Uroscience, Department of Urology, State University of Campinas, Unicamp and Pontifical Catholic University of Campinas, PUC-Campinas, Av. John Boyd Dunlop, Jardim Ipaussurama, Campinas, SP, Brazil

    Leonardo Oliveira Reis

  3. Department of Obstetric and Gynecology of Santa Casa, Jaú, SP, Brazil

    Mirce Milhomem da Mota Tamanini

  4. Section of Urogynecology and Pelvic Surgery, Department of Gynecology, Federal University of São Paulo, São Paulo, SP, Brazil

    Rodrigo Aquino Castro, Marair Gracio Ferreira Sartori & Manoel João Batista Castello Girão

Authors
  1. José Tadeu Nunes Tamanini
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  2. Leonardo Oliveira Reis
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  3. Mirce Milhomem da Mota Tamanini
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  4. Rodrigo Aquino Castro
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  5. Marair Gracio Ferreira Sartori
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  6. Manoel João Batista Castello Girão
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Contributions

JTNT: project development, data collection, data analysis, and manuscript writing/editing. LOR: data analysis, and manuscript writing/editing. MMMT: project development, data collection. RAC: data analysis, manuscript writing/editing. MGFS: manuscript writing/editing. MJBCG: manuscript final editing.

Corresponding author

Correspondence to Leonardo Oliveira Reis.

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Conflict of interest

The authors declare that they have no conflict of interest.

Research involving human participants

The local research ethics committee approved the protocol (no. 1335/2008) and the study was registered in The Brazilian Clinical Trials Registry (ReBEC) at https://www.ensaiosclinicos.gov.br/code: RBR-7M2XDY. All subjects signed informed consent.

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Tamanini, J.T.N., Reis, L.O., da Mota Tamanini, M.M. et al. No mesh versus mesh in the treatment of anterior vaginal wall prolapse: prospective, randomised, controlled trial, long-term follow-up. Int Urol Nephrol 52, 1839–1844 (2020). https://doi.org/10.1007/s11255-020-02503-0

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  • DOI: https://doi.org/10.1007/s11255-020-02503-0

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