Three-year outcomes of vaginal mesh for prolapse: a randomized controlled trial.
Obstet Gynecol
; 122(4): 770-777, 2013 Oct.
Article
en En
| MEDLINE
| ID: mdl-24084533
OBJECTIVE: To present the 3-year outcomes of a double-blind, multicenter, randomized trial comparing vaginal prolapse repair with and without mesh. METHODS: This was a planned final analysis of women with Pelvic Organ Prolapse Quantification (POP-Q) stage 2-4 prolapse randomized to traditional vaginal prolapse surgery without mesh and vaginal colpopexy repair with mesh. We evaluated anatomic, symptomatic, and combined cure rates for those with at least 3-year validated quality-of-life questionnaires and 2- or 3-year postoperative blinded POP-Q examination. Participants undergoing reoperation for recurrent prolapse were removed for anatomic and subjective outcomes analysis and considered failures for combined outcomes analysis. RESULTS: Sixty-five women were enrolled (33 mesh, 32 no mesh) before the study was prematurely halted as a result of a 15.6% mesh exposure rate. At 3 years, 51 of 65 (78%) had quality-of-life questionnaires (25 mesh, 26 no mesh) and 41 (63%) had examinations. Three participants died, three required reoperation for recurrent prolapse (all in mesh group), and eight were lost to follow-up. No differences were observed between groups at 3 years for prolapse stage or individual prolapse points. Stage improved for each group (90% and 86%) from baseline to 3 years (P<.01). Symptomatic improvement was observed with no differences in scores between groups. Cure rates did not differ between groups using a variety of definitions, and anatomic cure was lowest for the anterior compartment. CONCLUSION: There was no difference in 3-year cure rates when comparing patients undergoing traditional vaginal prolapse surgery without mesh with those undergoing vaginal colpopexy repair with mesh. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov, www.clinicaltrials.gov, NCT00475540. LEVEL OF EVIDENCE: : I.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Mallas Quirúrgicas
/
Prolapso de Órgano Pélvico
Tipo de estudio:
Clinical_trials
/
Observational_studies
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Prognostic_studies
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Risk_factors_studies
Aspecto:
Patient_preference
Límite:
Aged
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Female
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Humans
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Middle aged
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Obstet Gynecol
Año:
2013
Tipo del documento:
Article
Pais de publicación:
Estados Unidos