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

NCT07431788 | Recruiting

• 1 other identifier: 2026-04-06
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Adenomyoma of Uterus; Uterine Bleeding; Leiomyoma (Uterine Fibroids)

Keywords

Hysterectomy; Uterin Manipulator; Female Sexual Function; FSFI; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• 3-Month Postoperative Female Sexual Function Index Total Score

  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 Outcomes (5)

• Operative Time

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

• Postoperative Pain Assessed by Visual Analog Scale (VAS)

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

• Change in Hemoglobin Level

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

• Length of Hospital Stay

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

• Postoperative Complications Within 30 Days

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

Study Arms (2)

Abdominal Hysterectomy With Uterine Manipulator

EXPERIMENTAL

Total abdominal hysterectomy performed using a uterine manipulator.

Procedure: Uterine Manipulator

Abdominal Hysterectomy Without Uterine Manipulator

ACTIVE COMPARATOR

Conventional total abdominal hysterectomy performed without uterine manipulator.

Procedure: Conventional Abdominal Hysterectomy

Interventions

Uterine Manipulator PROCEDURE

Use of a uterine manipulator during total abdominal hysterectomy.

Abdominal Hysterectomy With Uterine Manipulator

Conventional Abdominal Hysterectomy PROCEDURE

Total abdominal hysterectomy without uterine manipulator.

Abdominal Hysterectomy Without Uterine Manipulator

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Erkan Gol: lead

Study Sites (1)

Bakirkoy Dr. Sadi Konuk Training and Research Hospital

Istanbul, Istanbul, 34147, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Leiomyoma; Uterine Hemorrhage

Condition Hierarchy (Ancestors)

Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Erkan Göl, MD

  University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Erkan Göl, MD

CONTACT

+905398517917; drerkangol@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Patients will be blinded to group allocation. Data analysis will be performed using coded group assignments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomized 1:1 into two parallel groups: abdominal hysterectomy with uterine manipulator versus abdominal hysterectomy without uterine manipulator.

Study Record Dates

• First Submitted: February 12, 2026
• First Posted: February 25, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 3, 2026

Record last verified: 2026-03

Locations

TU (1)