A multicenter prospective trial evaluating fetal bovine dermal graft (Xenform® Matrix) for pelvic reconstructive surgery

BMC Urology

Research Article

Howard B Goldstein¹  Joseph Maccarone¹  Oscar A Aguirre²  Martin J Naughton³  Rakesh C Patel⁴ 

[1] Cooper University Hospital, University of Medicine and Dentistry of New Jersey-Robert Wood Johnson Medical School, Camden, New Jersey, USA;Pelvic Specialty Care and Milestone Medical Research, Inc., Englewood, Colorado, USA;St. Mary's Regional Medical Center, Reno, Nevada, USA;Winter Park Urology Associates, Orlando, Florida, USA;

关键词: Pelvic Organ Prolapse;    Pelvic Organ Prolapse Quantification;    Pelvic Floor Reconstruction;    Pelvic Organ Prolapse Quantification Point;    Recurrent Cystocele;   

DOI  :  10.1186/1471-2490-10-21

 received in 2010-05-25, accepted in 2010-12-13,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundA prospective multicenter clinical study was performed to evaluate the safety and efficacy of a bovine dermal graft (Xenform® Matrix, Boston Scientific, Natick, MA, USA) during vaginal reconstructive surgery.MethodsForty-five women with ICS stage 2 or higher pelvic organ prolapse (POP) were enrolled at 4 centers. POP-Q, pelvic floor function (PFDI-20), sexual function (PISQ-12), and patient satisfaction tools were used to assess subjects at baseline, and at 2 and 6 weeks, and 3, 6 and 12 months post surgery. The significance of symptom score changes at 6 months and 1 year were determined by the t-test for paired data. Forty-three of the 45 patients completed the 12 month study.ResultsThe majority of the subjects had cystocele (98%) and/or rectocele (84%) defects at study entry. At 12 months, 74% of the defects had improved to a stage 0 or 1. Mean PFDI-20 scores improved by 72% (p < 0.001) at 12 months, and PISQ-12 scores were maintained during the follow-up period indicating no decline in sexual function. Three subjects experienced one serious adverse event each; one of the adverse events (constipation) was deemed by the study physician to be unrelated to Xenform®. One subject had severe pyelonephritis resulting in dialysis. This subject had a previous history of pyelonephritis, sepsis and acute renal failure. The third subject had a reported recurrent cystocele of moderate severity, possibly related to the device. No graft related erosions or pain lasting more than 30 days were reported. No subjects withdrew due to an adverse event.ConclusionThis study is the first to investigate the use of Xenform® Matrix in vaginal reconstructive surgery among patients with POP. Significant improvement was maintained at 12 months utilizing both objective and subjective assessment tools, confirming the safety and efficacy of this material in vaginal surgery.Trial RegistrationClinicalTrials.gov NCT01244165

【 授权许可】

CC BY   
© Goldstein et al; licensee BioMed Central Ltd. 2010. This article is published under license to BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.