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A multicenter, randomized trial comparing pelvic organ prolapse surgical treatment with native tissue and synthetic mesh: A 5‐year follow‐up study
Author(s) -
Silveira Simone dos Reis B.,
Auge Antomio PF.,
JarmyDibella Zsuzsanna IK.,
Margarido Paulo FR.,
Carramao Silvia,
Alves Rodrigues Claudinei,
Doumouchtsis Stergios K.,
Chada Baracat Edmund,
Milhem Haddad Jorge
Publication year - 2020
Publication title -
neurourology and urodynamics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.918
H-Index - 90
eISSN - 1520-6777
pISSN - 0733-2467
DOI - 10.1002/nau.24323
Subject(s) - medicine , native tissue , surgery , randomized controlled trial , sexual function , quality of life (healthcare) , cure rate , compartment (ship) , homogeneous , pelvic floor , tissue engineering , oceanography , nursing , biomedical engineering , geology , physics , thermodynamics
The aim of this study was to compare long‐term outcomes in patients who underwent either native tissue repair or monofilament macroporous polypropylene mesh. Methods This multicenter, randomized trial included—at the end of 5 years follow‐up—122 women with severe pelvic organ prolapse, who were randomly assigned to undergo surgical treatment using native tissue repair (native tissue group, n = 59) or synthetic mesh repair (mesh group, n = 63). Cure criterion was when pelvic organ prolapse‐quantification (POP‐Q) point was ≤0. Quality of life was assessed using the prolapse quality‐of‐life questionnaire and sexual function with the quality of sexual function. Results Groups were homogeneous preoperatively with the exception of the previous pelvic surgery variable, which was higher in mesh ( P = .019). Cure rate was significantly better for mesh group in the anterior compartment ( P = .002) and in the combination of all compartments ( P = .001). Native tissue group was significantly better when there was prolapse in the posterior and apical compartment ( P = .031). In the quality of life analysis, mesh group showed a significant improvement compared with native tissue group ( P = .004). Complications were significantly higher in mesh and recurrence in native tissue. Regarding the reoperation rate, there was no difference between groups, but native tissue had a higher reoperation rate due to recurrence ( P = .031). Conclusions Outcomes in women with severe POP were better with mesh use than native tissue repair, both in the anterior compartment and in the multicompartmental prolapse after 5‐year follow‐up. Complications were more common in the mesh group and recurrences were more frequent in the native tissue group.