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临床试验/NCT07090213
NCT07090213已完成不适用

Turkish Version of Pelvi-Perineal Surgery Sexuality Questionnaire: Translation, Cultural Adaptation and Validation

Bezmialem Vakif University1 个研究点 分布在 1 个国家目标入组 113 人开始时间: 2025年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
113
试验地点
1
主要终点
Pelvi-Perineal Surgery Sexuality Questionnaire

研究概览

简要总结

This prospective, multicentre observational study translates the 13-item Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ) from French to Turkish, culturally adapts it, and evaluates its reliability, validity and responsiveness in Turkish-speaking women covering from pelvic floor surgery.

详细描述

Sexual function is a key outcome after incontinence or prolapse surgery; however, no Turkish tool specifically captures surgery-related sexual issues. The Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ) was recently validated in France and measures two dimensions ("Sexual Health" and "Discomfort & Pain") with good psychometric performance.

The English version of PPSSQ will be adapted for Turkish use according to the established guidelines for cross-cultural adaptation of self-reported questionnaires. The guideline has 5 steps: (1) translation, (2) synthesis, (3) back translation, (4) evaluation by a team of experts, and (5) pretests. 80 sexually active and inactive women (≥18 y) with mid-urethral sling, vaginal or laparoscopic prolapse repair (with/without mesh) will be recruited. Participants will complete the Turkish version of the Female Sexual Function Index (FSFI-Turkish) on the first visit and again 7 days later for validation purposes. Internal consistency will be tested using Cronbach's alpha, and the test-retest reliability will be assessed by calculating the intra-class correlation coefficient.

研究设计

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

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Having had pelvic surgery more than 12 months ago
  • Being sexually active for the last three months
  • Being literate

排除标准

  • Not having had a sexual partner for at least three months
  • Receiving anti-estrogen therapy for any reason
  • Having a history of gynecological or breast cancer
  • Not understanding written Turkish

结局指标

主要结局

Pelvi-Perineal Surgery Sexuality Questionnaire

时间窗: 1 week

The Pelvi-Perineal Surgery Sexuality Questionnaire (PPSSQ) is a 13-question self-questionnaire validated in a population of sexually active women or not, operated on for stress urinary incontinence or pelvic organ prolapse by laparoscopy or vaginal surgery, with or without mesh. The domains are "Sexual Health" and "Discomfort and Pain." The questionnaire is calculated out of 100 points, with a higher score indicating better sexual function.

次要结局

  • Female Sexual Function Index (FSFI)(1 week)

研究者

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

Betül Çınar

Lecturer, PhD

Bezmialem Vakif University

研究点 (1)

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