Surgery; Maternal, Uterus or Pelvic Organs, Affecting FetusNCT07090213
Turkish Version of Pelvi-Perineal Surgery Sexuality Questionnaire
An observational study of Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus
- What is being tested?
- Survey using a questionnaire
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 22 Jul 2025to 5 Jan 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women who have had pelvic surgery more than 12 months ago and have been sexually active for the past three months.
Who may be able to join
- Having had pelvic surgery more than 12 months ago
- Being sexually active for the last three months
- Being literate
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Turkish Version of Pelvi-Perineal Surgery Sexuality Questionnaire: Translation, Cultural Adaptation and Validation
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.
Read the 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.
- Being tested
- Survey using a questionnaire
- Keywords
- validation, cultural adaptation, pelvic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey using a questionnaireOther
Also called Permission was obtained from the original owner of Pelvi-Perineal Surgery Sexuality Questionnaire - PPSSQ for the Turkish cultural adaptation, validity and reliability study.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 week
Secondary outcomes (1)
Female Sexual Function Index (FSFI)
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.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2025
- Study start22 Jul 2025
- Primary completion5 Nov 2025
- Study completion5 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Surgery; Maternal, Uterus or Pelvic Organs, Affecting FetusStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betül Çınar, Bezmialem Vakif University
- Investigators
- Betul Cinar, PhD, Principal investigator, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07090213
- Sponsor's protocol ID
- bvubcinar03
- Status last verified
- Jan 2026
- First submitted
- 21 Jul 2025
- Last updated
- 12 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Turkish Version of Pelvi-Perineal Surgery Sexuality Questionnaire: Translation, Cultural Adaptation and Validation
- ClinicalTrials.gov ID
- NCT07090213
- Acronym / sponsor ID
- bvubcinar03
- Keywords
- validation, cultural adaptation, pelvic surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 22 Jul 2025 (actual)
- Primary completion
- 5 Nov 2025 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 29 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women who have had pelvic surgery more than 12 months ago and have been sexually active for the past three months.
Key inclusion criteria (3 listed)
- Having had pelvic surgery more than 12 months ago
- Being sexually active for the last three months
- Being literate
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey using a questionnaireAlso: Permission was obtained from the original owner of Pelvi-Perineal Surgery Sexuality Questionnaire - PPSSQ for the Turkish cultural adaptation, validity and reliability study.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. | Other | – |
Primary outcome
Pelvi-Perineal Surgery Sexuality Questionnaire
Time frame: 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.
1 secondary outcome
Female Sexual Function Index (FSFI)
Time frame: 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Betul Cinar, PhD principal investigator
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Surgery; Maternal, Uterus or Pelvic Organs, Affecting Fetus, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pelvi-Perineal Surgery Sexuality Questionnaire (time frame: 1 week). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.