- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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.
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yağmur ÖZKAN, M.D.
- Número de teléfono: +90 5374318241
- Correo electrónico: yagmurolmez92@hotmail.com
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye), 34384
- Reclutamiento
- Prof.Dr.Cemil Taşcıoğlu City Hospital
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Contacto:
- Yağmur ÖZKAN, M.D.
- Número de teléfono: +90 5374318241
- Correo electrónico: yagmurolmez92@hotmail.com
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Female Sexual Function Index (FSFI) Score at 1 Month
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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FSFI Subdomain Scores at 1 Month
Periodo de tiempo: 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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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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FSFI Scores According to Histopathological Diagnosis
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades urogenitales
- Enfermedades Genitales
- Procesos Patológicos
- Enfermedades urogenitales femeninas
- Enfermedades urogenitales femeninas y complicaciones del embarazo
- Enfermedades uterinas
- Enfermedades Genitales Femeninas
- Hemorragia
- Hemorragia uterina
- Condiciones Patológicas, Signos y Síntomas
- Metrorragia
Otros números de identificación del estudio
- CTCH-FSFI-2026-001
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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