Leiomyoma (Uterine Fibroids)UMAHNCT07431788
The Effect of Uterine Manipulator Use During Abdominal Hysterectomy on Postoperative Sexual Function
A study testing Uterine Manipulator and Conventional Abdominal Hysterectomy in people with Leiomyoma (Uterine Fibroids) and Adenomyoma of Uterus, run by Erkan Gol at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Leiomyoma (Uterine Fibroids), Adenomyoma of Uterus, Uterine Bleeding
- What is being tested?
- Uterine Manipulator and Conventional Abdominal Hysterectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Gynecologic malignancy
- Major additional pelvic reconstructive surgery
- Severe psychiatric or neurologic disorder
- Inability to complete follow-up assessments
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Bakirkoy Dr. Sadi Konuk Training and Research Hospital
Istanbul, Istanbul, 34147
Erkan Göl, MD, +905398517917, drerkangol@gmail.com
Keziban Doğan, Professor, +905356336207, drkzbn70@gmail.com
About this study
Official title: 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.
- Being tested
- Uterine Manipulator, Conventional Abdominal Hysterectomy
- Keywords
- Hysterectomy, Uterin Manipulator, Female Sexual Function, FSFI, Randomized Controlled Trial
- Medical subject headings
- Leiomyoma, Uterine Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uterine ManipulatorProcedure or surgery
Use of a uterine manipulator during total abdominal hysterectomy.
Conventional Abdominal HysterectomyProcedure or surgery
Total abdominal hysterectomy without uterine manipulator.
| Study group | Role | What they receive |
|---|---|---|
| Abdominal Hysterectomy With Uterine Manipulator | Experimental | Total abdominal hysterectomy performed using a uterine manipulator. Receives: Procedure: Uterine Manipulator |
| Abdominal Hysterectomy Without Uterine Manipulator | Active comparator | Conventional total abdominal hysterectomy performed without uterine manipulator. Receives: Procedure: Conventional Abdominal Hysterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Assessed at postoperative month 3 (±2 weeks)
Secondary outcomes (5)
Operative Time
Total operative duration measured in minutes from skin incision to completion of skin closure during total abdominal hysterectomy.
Measured: Measured intraoperatively from skin incision to skin closure (single assessment during surgery)
Postoperative Pain Assessed by Visual Analog Scale (VAS)
Postoperative pain intensity measured using a 10-cm Visual Analog Scale (VAS), where 0 indicates no pain and 10 indicates worst imaginable pain.
Measured: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
Change in Hemoglobin Level
Difference between preoperative hemoglobin level and hemoglobin level measured 24 hours after surgery to assess perioperative blood loss.
Measured: Assessed at 6 hours (±1 hour), 12 hours (±2 hours), and 24 hours (±2 hours) after surgery
Length of Hospital Stay
Duration of hospitalization measured in days from the date of surgery until discharge.
Measured: From the date of surgery until hospital discharge, assessed up to 30 days postoperatively
Postoperative Complications Within 30 Days
Incidence of postoperative complications occurring within 30 days after surgery, classified according to the Clavien-Dindo grading system.
Measured: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2026
- Study start2 Mar 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Leiomyoma (Uterine Fibroids)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomized 1:1 into two parallel groups: abdominal hysterectomy with uterine manipulator versus abdominal hysterectomy without uterine manipulator.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erkan Gol
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Erkan Gol, Bakirkoy Dr. Sadi Konuk Research and Training Hospital
- Investigators
- Erkan Göl, MD, Principal investigator, University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07431788
- Sponsor's protocol ID
- 2026-04-06
- Acronym
- UMAH
- Status last verified
- Mar 2026
- First submitted
- 12 Feb 2026
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Controlled Trial Evaluating the Impact of Uterine Manipulator Use During Total Abdominal Hysterectomy on Postoperative Female Sexual Function
- ClinicalTrials.gov ID
- NCT07431788
- Acronym / sponsor ID
- UMAH / 2026-04-06
- Keywords
- Hysterectomy, Uterin Manipulator, Female Sexual Function, FSFI, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Erkan GolOther government
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 25 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomized 1:1 into two parallel groups: abdominal hysterectomy with uterine manipulator versus abdominal hysterectomy without uterine manipulator.
| Arm | Type | Receives |
|---|---|---|
| Abdominal Hysterectomy With Uterine Manipulator | Experimental | Procedure: Uterine ManipulatorTotal abdominal hysterectomy performed using a uterine manipulator. |
| Abdominal Hysterectomy Without Uterine Manipulator | Active comparator | Procedure: Conventional Abdominal HysterectomyConventional total abdominal hysterectomy performed without uterine manipulator. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Gynecologic malignancy
- Major additional pelvic reconstructive surgery
- Severe psychiatric or neurologic disorder
- Inability to complete follow-up assessments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uterine ManipulatorUse of a uterine manipulator during total abdominal hysterectomy. | Procedure or surgery | Abdominal Hysterectomy With Uterine Manipulator |
| Conventional Abdominal HysterectomyTotal abdominal hysterectomy without uterine manipulator. | Procedure or surgery | Abdominal Hysterectomy Without Uterine Manipulator |
Primary outcome
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.
5 secondary outcomes
Operative Time
Time frame: 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
Change in Hemoglobin Level
Time frame: 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
Postoperative Complications Within 30 Days
Time frame: From the date of surgery until 30 days postoperatively (complications assessed up to 30 days after surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Erkan Göl, MD principal investigator
University of Health Sciences, Bakirkoy Dr. Sadi Konuk Training and Research Hospital, Istanbul, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Uterine Manipulator and Conventional Abdominal Hysterectomy in people with Leiomyoma (Uterine Fibroids) and Adenomyoma of Uterus, run by Erkan Gol at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Erkan Göl, MD (+905398517917, drerkangol@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
3-Month Postoperative Female Sexual Function Index Total Score (time frame: Assessed at postoperative month 3 (±2 weeks)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026.