NCT07090213

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jul 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2025

Completed
1 day until next milestone

Study Start

First participant enrolled

July 22, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 29, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 5, 2026

Completed
Last Updated

January 12, 2026

Status Verified

January 1, 2026

Enrollment Period

4 months

First QC Date

July 21, 2025

Last Update Submit

January 9, 2026

Conditions

Keywords

validationcultural adaptationpelvic surgery

Outcome Measures

Primary Outcomes (1)

  • Pelvi-Perineal Surgery Sexuality Questionnaire

    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.

    1 week

Secondary Outcomes (1)

  • Female Sexual Function Index (FSFI)

    1 week

Interventions

Eighty 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.

Also known as: Permission was obtained from the original owner of Pelvi-Perineal Surgery Sexuality Questionnaire - PPSSQ for the Turkish cultural adaptation, validity and reliability study.

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsNo. Participant eligibility is based on assigned sex at birth (biological female).
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women who have had pelvic surgery more than 12 months ago and have been sexually active for the past three months.

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem Vakif University

Istanbul, Turkey (Türkiye)

Location

Study Officials

  • Betul Cinar, PhD

    Bezmialem Vakif University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, PhD

Study Record Dates

First Submitted

July 21, 2025

First Posted

July 29, 2025

Study Start

July 22, 2025

Primary Completion

November 5, 2025

Study Completion

January 5, 2026

Last Updated

January 12, 2026

Record last verified: 2026-01

Locations