Pain during IUS insertion: traditional method vs ultrasound-guided (TAS) technique
Official title: The PAINLESS Study: Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion
Run by University Hospital, Ghent · NCT07315646 · Data updated 2026-11-12
This study tests whether using a transabdominal ultrasound (TAS) guided method reduces pain for women getting an intrauterine system for contraception or treatment.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 60 Years |
| Sex | Women only |
| Enrollment | 50 (estimated) |
| Sponsor | University Hospital, Ghent Academic / other |
| Locations | 1 site (Ghent) |
| Status | Recruiting |
| Started | February 11, 2026 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2027 |
| Registry record updated | July 30, 2026 |
| Trial ID | NCT07315646 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Dutch-speaking women aged 18–60 who wish to have an IUS and meet safety criteria with no history of difficult IUS placement or cervical stenosis.
✕Probably not a fit
Women with contraindications to IUS or those experiencing factors that make ultrasound guidance ineffective may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This interventional study compares the standard cervical technique for inserting an intrauterine system with a transabdominal ultrasound guided approach. The TAS method aims to minimize pain during insertion by guiding instrument placement without relying on the traditional traction method. Eligible participants are Dutch-speaking women aged 18 to 60 who wish to use an IUS for contraception, abnormal uterine bleeding, or menopausal symptoms and who meet safety criteria. The study is led by University Hospital Ghent with collaboration from Imelda Hospital and takes place at Ghent University Hospital. No phase information is provided for this trial.
Why it matters
Potential benefit: If successful, the TAS technique could reduce pain during IUS insertion and improve comfort and uptake of LARC methods.
How similar studies have gone: Prior data suggest ultrasound-guided approaches can influence pain experience in similar procedures, but this exact TAS approach for IUS insertion is novel in this setting.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women between18 years and 60 years (at the time of signing the ICF) * Who wish to have an IUS (Kyleena/Mirena) for reasons of family planning, conservative treatment for abnormal uterine bleeding or as part of hormonal treatment for menopausal symptoms * Dutch-speaking subjects Exclusion Criteria: * History of difficult IUS placement * Known cervical stenosis * Asherman's syndrome * Standard contraindications to an IUS (eg breast cancer, recent deep vein thrombosis, anatomical uterine abnormalities, pregnancy, acute PID, cervicitis, vaginitis or any lower genital tract infection, cervical or endometrial malignancy, history of septic abortion or postpartum endometritis in the last 3 months,.. ) * Current pelvic inflammatory disease * Pregnancy * Trophoblastic disease * Known cervical or endometrial carcinoma * Patients who have the profession of midwife, nurse or doctor.
Where it's running
-
Ghent University Hospital
Ghent, Belgium Recruiting
Study contacts
- Principal investigator: Steven Weyers, MD, PhD — University Hospital, Ghent
- Study coordinator: Margot Van Geyte, MD
- Email: margot.vangeyte@uzgent.be
- Phone: +329323044
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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.