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.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | March 2, 2026 |
| Main results expected | February 2027 |
| Study ends | February 2027 |
| Registry record updated | March 3, 2026 |
| Trial ID | NCT07431788 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
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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
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.