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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.

調査の概要

詳細な説明

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.

研究の種類

観察的

入学 (推定)

210

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

コホートと介入

グループ/コホート
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.

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Female Sexual Function Index (FSFI) Score at 1 Month
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
FSFI Subdomain Scores at 1 Month
時間枠: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

その他の成果指標

結果測定
メジャーの説明
時間枠
FSFI Scores According to Histopathological Diagnosis
時間枠: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
時間枠:1 Month After Endometrial Sampling
Comparison of total FSFI scores between symptomatic and asymptomatic patients undergoing endometrial sampling.
1 Month After Endometrial Sampling

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2026年4月15日

一次修了 (推定)

2027年5月15日

研究の完了 (推定)

2027年5月15日

試験登録日

最初に提出

2026年6月1日

QC基準を満たした最初の提出物

2026年6月1日

最初の投稿 (実際)

2026年6月5日

学習記録の更新

投稿された最後の更新 (実際)

2026年6月5日

QC基準を満たした最後の更新が送信されました

2026年6月1日

最終確認日

2026年6月1日

詳しくは

本研究に関する用語

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

IPD プランの説明

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

医薬品およびデバイス情報、研究文書

米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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