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NCT Number: NCT07431788

The Effect of Uterine Manipulator Use During Abdominal Hysterectomy on Postoperative Sexual Function

This prospective, single-center, randomized controlled trial aims to evaluate the effect of uterine manipulator use during total abdominal hysterectomy on postoperative female sexual function at 3 months, assessed by the Female Sexual Function Index (FSFI). Secondary outcomes include operative time, perioperative hemoglobin change, postoperative pain (VAS), hospital stay duration, and 30-day complications.

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Key information

Conditions

Leiomyoma (Uterine Fibroids) Adenomyoma of Uterus Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Hemorrhage Leiomyoma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Neoplasms, Muscle Tissue Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases Uterine Bleeding Uterine Diseases Uterine Hemorrhage

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged ≥18 years
  • Planned total abdominal hysterectomy for benign indications
  • Sexually active within the last 4 weeks
  • Able to complete the Female Sexual Function Index (FSFI) questionnaire
  • Provided written informed consent

Exclusion criteria

  • Gynecologic malignancy
  • Major additional pelvic reconstructive surgery
  • Severe psychiatric or neurologic disorder
  • Inability to complete follow-up assessments

Treatment and study plan

Uterine Manipulator

Procedure

Use of a uterine manipulator during total abdominal hysterectomy.

Conventional Abdominal Hysterectomy

Procedure

Total abdominal hysterectomy without uterine manipulator.

Primary outcomes

  1. 3-Month Postoperative Female Sexual Function Index Total Score

    Time frame: Assessed at postoperative month 3 (±2 weeks)

    Female Sexual Function Index (FSFI) total score measured at 3 months after surgery.

    The FSFI is a validated 19-item questionnaire assessing sexual function across six domains.

    Total scores range from 2 to 36, with higher scores indicating better sexual function.

Secondary outcomes

  1. Operative Time

    Time frame: Measured intraoperatively from skin incision to skin closure (single assessment during surgery)

    Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy.

  2. Postoperative Pain Assessed by Visual Analog Scale (VAS)

    Time frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery

    Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.

  3. Change in Hemoglobin Level

    Time frame: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery

    Difference between preoperative hemoglobin level and hemoglobin level measured 24 hours after surgery to assess perioperative blood loss.

  4. Length of Hospital Stay

    Time frame: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively

    Duration of hospitalization measured in days from the date of surgery until discharge.

  5. Postoperative Complications Within 30 Days

    Time frame: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)

    Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system.

Study contacts

Contact information is provided by the study sponsor or research team.

Erkan Göl, MD

CONTACT

[email protected]

+905398517917

Sponsors and collaborators

Lead sponsor

Erkan Gol

Other Gov

Registry information

Official study title

A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function

Acronym: UMAH

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Feb 25, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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