Clinical Trials Directory

Trials / Completed

CompletedNCT07090213

Turkish Version of Pelvi-Perineal Surgery Sexuality Questionnaire

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

Status
Completed
Phase
Study type
Observational
Enrollment
113 (actual)
Sponsor
Bezmialem Vakif University · Academic / Other
Sex
Female
Age
18 Years – 65 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
OTHERSurvey using a questionnaireEighty women, determined by the number of questions times the rule of 10, will be asked to fill out the Pelvi-Perineal Surgery Sexuality Questionnaire - PPSSQ and Female Sexual Function Index (FSFI) questionnaires and will be asked to fill out the PPSSQ again 7 days later for test-retest reliability.

Timeline

Start date
2025-07-22
Primary completion
2025-11-05
Completion
2026-01-05
First posted
2025-07-29
Last updated
2026-01-12

Locations

1 site across 1 country: Turkey (Türkiye)

Source: ClinicalTrials.gov record NCT07090213. Inclusion in this directory is not an endorsement.