- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07628660
Assessment of Female Sexual Function Index (FSFI) Scores at 1 Month After Endometrial Sampling Performed Under Sedo-Analgesia or Local Anesthesia (FSFI-ENDO)
Evaluation of One-Month Female Sexual Function Index (FSFI) Scores in Women Undergoing Endometrial Sampling Under Sedo-Analgesia Versus Local Anesthesia
Endometrial sampling is a commonly performed gynecological procedure used for the diagnosis of abnormal uterine bleeding and endometrial abnormalities. Different anesthetic techniques may be used during the procedure, including sedo-analgesia and local anesthesia.
The purpose of this prospective observational study is to evaluate whether the anesthetic technique used during endometrial sampling affects female sexual function one month after the procedure. Female sexual function will be assessed using the validated Female Sexual Function Index (FSFI) questionnaire.
A total of 210 women undergoing endometrial sampling at Prof. Dr. Cemil Taşcıoğlu City Hospital will be enrolled. Participants will be assigned to groups according to the anesthetic technique used during their routine clinical care. FSFI scores obtained at the one-month follow-up visit will be compared between women who underwent the procedure under sedo-analgesia and those who received local anesthesia.
Secondary analyses will include comparison of FSFI scores according to symptom status and histopathological diagnosis.
The findings of this study may contribute to a better understanding of the impact of anesthetic techniques on postoperative sexual health and quality of life in women undergoing gynecological procedures.
Studieoversigt
Status
Detaljeret beskrivelse
Endometrial sampling is a widely used gynecological procedure for the diagnosis and management of abnormal uterine bleeding and suspected endometrial pathology. The procedure may be performed under different anesthetic techniques, including sedo-analgesia and local anesthesia. Sedo-analgesia provides patient comfort through the administration of short-acting sedative and analgesic agents, whereas local anesthesia reduces procedural pain by blocking cervical nerve transmission. Both techniques are routinely used in clinical practice.
Sexual health is an important component of physical and psychological well-being. Procedure-related pain, anxiety, and postoperative discomfort may influence female sexual function and quality of life. However, limited data are available regarding the potential impact of anesthetic technique during endometrial sampling on subsequent sexual function.
The aim of this prospective observational cohort study is to evaluate whether undergoing endometrial sampling under sedo-analgesia or local anesthesia affects Female Sexual Function Index (FSFI) scores at one month after the procedure.
The study will be conducted at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital, between April 2026 and April 2027. A total of 210 women aged 18 to 60 years undergoing endometrial sampling will be enrolled. Participants will be allocated into two cohorts according to the anesthetic technique used during routine clinical care:
Sedo-analgesia group (n=105) Local anesthesia group (n=105) Female sexual function will be evaluated at the one-month follow-up visit using the validated Female Sexual Function Index (FSFI), a 19-item questionnaire assessing six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain.
Demographic and clinical characteristics, including age, gravidity, parity, and abortion history, will also be recorded. FSFI scores will be compared between the two groups to determine whether anesthetic technique is associated with differences in postoperative sexual function.
Secondary analyses will include comparison of FSFI scores according to symptom status and histopathological diagnosis.
The results of this study may provide evidence regarding the influence of anesthetic management during gynecological procedures on female sexual health and may contribute to improving patient-centered perioperative care.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Yağmur ÖZKAN, M.D.
- Telefonnummer: +90 5374318241
- E-mail: yagmurolmez92@hotmail.com
Studiesteder
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Istanbul, Tyrkiet (Türkiye), 34384
- Rekruttering
- Prof.Dr.Cemil Taşcıoğlu City Hospital
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Kontakt:
- Yağmur ÖZKAN, M.D.
- Telefonnummer: +90 5374318241
- E-mail: yagmurolmez92@hotmail.com
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- Female patients aged 18 to 60 years
- Undergoing endometrial sampling at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital
- Undergoing the procedure under sedo-analgesia or local anesthesia as part of routine clinical practice
- Attendance at the 1-month follow-up visit
- Ability to complete the Female Sexual Function Index (FSFI) questionnaire
Exclusion Criteria:
- Age younger than 18 years or older than 60 years
- Presence of known chronic systemic disease
- Incomplete clinical or follow-up data
- Failure to attend the 1-month follow-up visit
- Inability or unwillingness to complete the FSFI questionnaire
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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Sedo-Analgesia Group
Patients undergoing endometrial sampling under intravenous sedo-analgesia as part of routine clinical care.
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Local Anesthesia Group
Patients undergoing endometrial sampling under local anesthesia as part of routine clinical care.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Female Sexual Function Index (FSFI) Score at 1 Month
Tidsramme: 1 Month After Endometrial Sampling
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Assessment of female sexual function one month after endometrial sampling using the validated Female Sexual Function Index (FSFI) questionnaire.
Total FSFI scores will be compared between patients undergoing endometrial sampling under sedo-analgesia and those undergoing the procedure under local anesthesia.
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1 Month After Endometrial Sampling
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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FSFI Subdomain Scores at 1 Month
Tidsramme: 1 Month After Endometrial Sampling
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Assessment of FSFI subdomain scores, including desire, arousal, lubrication, orgasm, satisfaction, and pain, one month after endometrial sampling.
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1 Month After Endometrial Sampling
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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FSFI Scores According to Histopathological Diagnosis
Tidsramme: 1 Month After Endometrial Sampling
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Comparison of total FSFI scores between patients with benign and malignant histopathological results after endometrial sampling.
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1 Month After Endometrial Sampling
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FSFI Scores According to Symptom Status
Tidsramme: 1 Month After Endometrial Sampling
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Comparison of total FSFI scores between symptomatic and asymptomatic patients undergoing endometrial sampling.
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1 Month After Endometrial Sampling
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Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- CTCH-FSFI-2026-001
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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