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

March 2, 2026 updated by: Erkan Gol

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34147
        • Recruiting
        • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
        • Contact:
        • Principal Investigator:
          • Erkan Göl, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Abdominal Hysterectomy With Uterine Manipulator
Total abdominal hysterectomy performed using a uterine manipulator.
Procedure: Uterine Manipulator
Use of a uterine manipulator during total abdominal hysterectomy.
Active Comparator: Abdominal Hysterectomy Without Uterine Manipulator
Conventional total abdominal hysterectomy performed without uterine manipulator.
Procedure: Conventional Abdominal Hysterectomy
Total abdominal hysterectomy without uterine manipulator.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Assessed at postoperative month 3 (±2 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Measured intraoperatively from skin incision to skin closure (single assessment during surgery)
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.
Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
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.
Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
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.
From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
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.
From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Erkan Gol

Investigators

  • Principal Investigator: Erkan Göl, MD, University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 20, 2026

First Posted (Actual)

February 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 3, 2026

Last Update Submitted That Met QC Criteria

March 2, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2026-04-06

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Uterine Bleeding

Clinical Trials on Uterine Manipulator

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Egypt

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe