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临床试验/NCT02890498
NCT02890498已完成不适用

Vaginal Microbiota as a Decisive Factor in Vaginal Prosthetic Surgery

Centre Hospitalier Universitaire de Nīmes1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015年12月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
41
试验地点
1
主要终点
Microbiota diversity (Shannon's H index)

研究概览

简要总结

Retrospective analysis of vaginal microbiota in the post-operative course of patient operated for genital prolapse with vaginal mesh with or without mesh related complication

详细描述

We propose to collect vaginal specimens to obtain exfoliated mucosal cells from women who had vaginal mesh implantation for POP complicated by mesh erosion into the vagina (cases).

We aim to recruit women who will receive exactly the same clinical investigations (outlined below), follow up and management.

Samples from patients without complications after mesh surgery will be used as controls since there are ethical difficulties in obtaining cold-cup swabs from 'normal' women and cystoscopy for conditions other than OAB or USI in premenopausal women is rare.

Both cases and controls will be identified by the urogynaecology team based on surgical outcome reports and follow-up documentation. Cases and controls will be invited to participate by the research team. Relevant members of the research team (Dr Nikolaus Veit-Rubin, Pr Renaud DeTayrac, and Mr Vikram Khullar) have extensive experience in urogynaecological investigation and pelvic floor assessment.

Cases and controls will be provided with an information leaflet about the study and will be asked to sign informed consent for the biopsies and a high vaginal swab will be taken. Consent will be taken either a trained member of the urogynaecology team. All participants will complete the 'P-QoL Questionnaire" for symptoms relative to POP. Clinical assessment will include a comprehensive relevant past medical history, calculation of BMI, urinalysis, standardized POP-Q Quantification and abdominal examination.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Females aged 18 and over who have consented for vaginal mesh surgery for pelvic organ prolapse at the the Nîmes University Hospital, France

排除标准

  • Pregnant or breast feeding
  • Unwilling or unable to complete questionnaire or give valid consent.

结局指标

主要结局

Microbiota diversity (Shannon's H index)

时间窗: Day 0

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de Nīmes
申办方类型
Other
责任方
Sponsor

研究点 (1)

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