Clinical trial Recruiting at 1 site Interventional Ages 18 and up Women only

Effect of a uterine manipulator on sexual function after total abdominal hysterectomy

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

Run by Bakirkoy Dr. Sadi Konuk Research and Training Hospital · NCT07431788 · Data updated 2026-11-12

This tests whether using a uterine manipulator during total abdominal hysterectomy changes sexual function in women having the operation.

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Quick facts

Study typeInterventional
Ages18 Years and up
SexWomen only
Enrollment60 (estimated)
SponsorBakirkoy Dr. Sadi Konuk Research and Training Hospital
Government
Locations1 site (Istanbul, Istanbul)
StatusRecruiting
StartedMarch 2, 2026
Main results expectedFebruary 2027
Study endsFebruary 2027
Registry record updatedMarch 3, 2026
Trial IDNCT07431788 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Women aged 18 or older who are sexually active, scheduled for total abdominal hysterectomy for benign reasons, able to complete the FSFI questionnaire, and willing to provide consent and follow-up.

Probably not a fit

Women with gynecologic malignancy, those needing major additional pelvic reconstructive procedures, those with severe psychiatric or neurologic disorders, or those not sexually active are unlikely to benefit from this trial.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center randomized controlled trial comparing total abdominal hysterectomy performed with a uterine manipulator to conventional abdominal hysterectomy without a manipulator. Women scheduled for hysterectomy for benign conditions who are sexually active and able to complete the Female Sexual Function Index (FSFI) are randomized and followed for outcomes. The primary outcome is FSFI score at 3 months after surgery, and secondary outcomes include operative time, perioperative hemoglobin change, postoperative pain (VAS), length of hospital stay, and 30-day complications. The trial is conducted at a tertiary training and research hospital in Istanbul with standardized perioperative care and follow-up visits for outcome collection.

Why it matters

Potential benefit: If successful, the findings could help surgeons choose an approach that better preserves or improves postoperative sexual function for women undergoing abdominal hysterectomy.

How similar studies have gone: Previous work on uterine manipulators has mainly looked at operative metrics and safety, and randomized evidence specifically measuring postoperative female sexual function is limited.

Who can join: the full rules

Show full inclusion / exclusion criteria
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

Where it's running

  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital
    Istanbul, Istanbul, Turkey (Türkiye)
    Recruiting

Study contacts

  • Principal investigator: Erkan Göl, MD — University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey
  • Study coordinator: Erkan Göl, MD
  • Email: drerkangol@gmail.com
  • Phone: +905398517917

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How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.