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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.

Studie Overzicht

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Geschat)

210

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population consists of women aged 18-60 years undergoing endometrial sampling for various gynecological indications at the Department of Obstetrics and Gynecology, Prof. Dr. Cemil Taşcıoğlu City Hospital. Participants receiving sedo-analgesia or local anesthesia as part of routine clinical care will be included. Female sexual function will be assessed one month after the procedure using the Female Sexual Function Index (FSFI), and subgroup analyses may be performed according to symptom status and histopathological diagnosis.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Sedo-Analgesia Group
Patients undergoing endometrial sampling under intravenous sedo-analgesia as part of routine clinical care.
Local Anesthesia Group
Patients undergoing endometrial sampling under local anesthesia as part of routine clinical care.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Female Sexual Function Index (FSFI) Score at 1 Month
Tijdsspanne: 1 Month After Endometrial Sampling
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.
1 Month After Endometrial Sampling

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
FSFI Subdomain Scores at 1 Month
Tijdsspanne: 1 Month After Endometrial Sampling
Assessment of FSFI subdomain scores, including desire, arousal, lubrication, orgasm, satisfaction, and pain, one month after endometrial sampling.
1 Month After Endometrial Sampling

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
FSFI Scores According to Histopathological Diagnosis
Tijdsspanne: 1 Month After Endometrial Sampling
Comparison of total FSFI scores between patients with benign and malignant histopathological results after endometrial sampling.
1 Month After Endometrial Sampling
FSFI Scores According to Symptom Status
Tijdsspanne: 1 Month After Endometrial Sampling
Comparison of total FSFI scores between symptomatic and asymptomatic patients undergoing endometrial sampling.
1 Month After Endometrial Sampling

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

15 april 2026

Primaire voltooiing (Geschat)

15 mei 2027

Studie voltooiing (Geschat)

15 mei 2027

Studieregistratiedata

Eerst ingediend

1 juni 2026

Eerst ingediend dat voldeed aan de QC-criteria

1 juni 2026

Eerst geplaatst (Werkelijk)

5 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

5 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

1 juni 2026

Laatst geverifieerd

1 juni 2026

Meer informatie

Termen gerelateerd aan deze studie

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Beschrijving IPD-plan

Individual participant data will not be shared to protect participant confidentiality and in accordance with institutional and ethical regulations governing clinical research data.

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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