Turkish Version of Pelvi-Perineal Surgery Sexuality Questionnaire

Not yet recruiting

• Conditions: Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus

• Registration Number: NCT07090213
• Lead Sponsor: Bezmialem Vakif University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-21
• Study First Submitted QC: 2025-07-21
• Last Update Submitted: 2025-07-21
• Study Start: 2025-07-22
• Study First Posted: 2025-07-29
• Last Update Posted: 2025-07-29
• Primary Completion: 2025-08-22
• Study Completion: 2025-09-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pelvi-Perineal Surgery Sexuality Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Female Sexual Function Index (FSFI)	1 week	It is a 19-item multidimensional self-reporting measure that quantified female sexual dysfunction in six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. These questions ask about patients' sexual feelings and responses during the past 4 weeks. FSFI use a 5-point Likert scale ranging from 1-5 with higher scores indicating greater levels of sexual functioning.