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The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial.

Delroy CA, Castro Rde A, Dias MM, Feldner PC, Bortolini MA, Girão MJ, Sartori MG - Int Urogynecol J (2013)

Bottom Line: Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).Quality of life equally improved after both techniques.

View Article: PubMed Central - PubMed

Affiliation: Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Rua Joaquim Floriano, 871 cj 92, São Paulo, SP, Brazil, 04534-000, delroy@terra.com.br.

ABSTRACT

Introduction and hypothesis: The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.

Methods: This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.

Results: The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5% (95% confidence interval 0.068-0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5% of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).

Conclusions: Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.

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Anatomical success defined as point Ba < −1. Values are given in % of patients that met the cure criteria from each group. Pearson’s chi-square test. A significant difference is indicated by *p < 0.05
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Fig2: Anatomical success defined as point Ba < −1. Values are given in % of patients that met the cure criteria from each group. Pearson’s chi-square test. A significant difference is indicated by *p < 0.05

Mentions: Per protocol and intention to treat analyses evidenced that around 82.5 % of the patients from the MESH group and 56.4 % from the AC group met the strict criteria for anatomical success in the anterior compartment (95 % confidence interval 0.068–0.54) at the 1-year follow-up, and this difference showed statistical significance (p = 0.018) (Fig. 2). The mean preoperative point Ba was +2.22 cm in the AC patients and +2.77 cm in the patients that received MESH; mean postoperative values were −1.44 and −1.97 cm, respectively (Table 2). The number needed to treat (NNT) was calculated as 4.Fig. 2


The use of transvaginal synthetic mesh for anterior vaginal wall prolapse repair: a randomized controlled trial.

Delroy CA, Castro Rde A, Dias MM, Feldner PC, Bortolini MA, Girão MJ, Sartori MG - Int Urogynecol J (2013)

Anatomical success defined as point Ba < −1. Values are given in % of patients that met the cure criteria from each group. Pearson’s chi-square test. A significant difference is indicated by *p < 0.05
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

Show All Figures
getmorefigures.php?uid=PMC3824218&req=5

Fig2: Anatomical success defined as point Ba < −1. Values are given in % of patients that met the cure criteria from each group. Pearson’s chi-square test. A significant difference is indicated by *p < 0.05
Mentions: Per protocol and intention to treat analyses evidenced that around 82.5 % of the patients from the MESH group and 56.4 % from the AC group met the strict criteria for anatomical success in the anterior compartment (95 % confidence interval 0.068–0.54) at the 1-year follow-up, and this difference showed statistical significance (p = 0.018) (Fig. 2). The mean preoperative point Ba was +2.22 cm in the AC patients and +2.77 cm in the patients that received MESH; mean postoperative values were −1.44 and −1.97 cm, respectively (Table 2). The number needed to treat (NNT) was calculated as 4.Fig. 2

Bottom Line: Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).Quality of life equally improved after both techniques.

View Article: PubMed Central - PubMed

Affiliation: Sector of Urogynecology and Vaginal Surgery, Department of Gynecology, Federal University of São Paulo, Rua Joaquim Floriano, 871 cj 92, São Paulo, SP, Brazil, 04534-000, delroy@terra.com.br.

ABSTRACT

Introduction and hypothesis: The aim of the study was to compare the efficacy and safety of transvaginal trocar-guided polypropylene mesh insertion with traditional colporrhaphy for treatment of anterior vaginal wall prolapse.

Methods: This is a randomized controlled trial in which women with advanced anterior vaginal wall prolapse, at least stage II with Ba ≥ +1 cm according to the Pelvic Organ Prolapse Quantification (POP-Q) classification, were randomly assigned to have either anterior colporrhaphy (n = 39) or repair using trocar-guided transvaginal mesh (n = 40). The primary outcome was objective cure rate of the anterior compartment (point Ba) assessed at the 12-month follow-up visit, with stages 0 and I defined as anatomical success. Secondary outcomes included quantification of other vaginal compartments (POP-Q points), comparison of quality of life by the prolapse quality of life (P-QOL) questionnaire, and complication rate between the groups after 1 year. Study power was fixed as 80% with 5% cutoff point (p < 0.05) for statistical significance.

Results: The groups were similar regarding demographic and clinical preoperative parameters. Anatomical success rates for colporrhaphy and repair with mesh placement groups were 56.4 vs 82.5% (95% confidence interval 0.068-0.54), respectively, and the difference between the groups was statistically significant (p = 0.018). Similar total complication rates were observed in both groups, with tape exposure observed in 5% of the patients. There was a significant improvement in all P-QOL domains as a result of both procedures (p < 0.001), but they were not distinct between groups (p > 0.05).

Conclusions: Trocar-guided transvaginal synthetic mesh for advanced anterior POP repair is associated with a higher anatomical success rate for the anterior compartment compared with traditional colporrhaphy. Quality of life equally improved after both techniques. However, the trial failed to detect differences in P-QOL scores and complication rates between the groups.

Show MeSH
Related in: MedlinePlus