Effect of a uterine manipulator on sexual function after total abdominal hysterectomy
A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function
This tests whether using a uterine manipulator during total abdominal hysterectomy changes sexual function in women having the operation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Bakirkoy Dr. Sadi Konuk Research and Training Hospital Government |
| Locations | 1 site (Istanbul, Istanbul) |
| Trial ID | NCT07431788 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Previous work on uterine manipulators has mainly looked at operative metrics and safety, and randomized evidence specifically measuring postoperative female sexual function is limited.
Eligibility criteria
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 this trial is running
Istanbul, Istanbul
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.