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临床试验/NCT03188744
NCT03188744Unknown不适用

Impact of Cancer Treatment on the Pelvic Floor Function in Survivors of Cervical Cancer

University of Sao Paulo1 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年1月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
150
试验地点
1
主要终点
Pelvic floor muscles function

研究概览

简要总结

Introduction: Pelvic floor muscle dysfunctions (PFMD) represent an important public health problem that manifests itself through lower urinary tract symptoms (LUTS), anorectal and sexual dysfunction. PFMD is a common problem in cervical cancer survivors (CC) with a negative impact on quality of life (QoL). Objective: This study aims to evaluate the effect of oncological treatment on the function of pelvic floor muscles (PFM) of survivors of CC. Methods: Patients diagnosed with CC, of any stage, histology and degree, accompanied by the Oncology Gynecology Service of the Hospital das Clínicas of the Medical School of Ribeirão Preto at the University of São Paulo, will be studied in the period between 2004 and 2014. Four study groups will be formed: (1) Patients with CC with PFMD; (2) Patients with CC without PFMD; : (3) Patients without CC with PFMD; (2) Patients without CC without PFMD. Non-cancer patients will be recruited into the community. For the analysis of the prevalence of PFMD will be applied to the discomfort Questionnaire on pelvic floor (IDPE-20) for evaluation of pelvic organ prolapse (POP) complaints, anorectal symptoms and urinary incontinence, and the Sexual Questionnaire for urinary incontinence and pelvic organ prolapse (PISQ -12) for evaluation of sexual function. Both questionnaires have already been validated for the Portuguese language and are specific for women with PFMD. The pelvic floor impact questionnaire (PFIQ-7) will also be applied to assess the impact of PFMD on quality of life, daily living activities and emotional health. For the evaluation of general QOL, the EORTC questionnaire QLQ-C30 and its specific module for patients with CC, QLQ-CX24 will be used. The evaluation of PFM function will include vaginal palpation (Modified Oxford Scale) and perineometry (Peritron).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

性别
Female
接受健康志愿者

入选标准

  • Women diagnosed with CC; No distinction as to age, race, scholarity and religion; Women in follow-up at Clinical Hospital of Medical School of Ribeirão Preto of University São Paulo.

排除标准

  • Women who did not complete the proposed cancer treatment; Women who presented CC as the second malignant neoplasm; Pregnant women; Failure to respond to the proposed questionnaires.

结局指标

主要结局

Pelvic floor muscles function

时间窗: Four months

Evaluated through vaginal palpation and perineometry.

次要结局

  • Quality of life in the pelvic floor muscles dysfunction.(Four months)
  • Prevalence of the pelvic floor muscles dysfunction.(Four months)
  • Overall quality of life.(Four months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Aline Moreira Ribeiro

MSc.

University of Sao Paulo

研究点 (1)

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