Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IUS (intrauterine system) insertion.
- Who it may be relevant to
- Registry conditions: Intra-uterine Device Placement. Basic parameters: 18 years — 60 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The PAINLESS Study: Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion
Overview
Rationale: The 2019 Belgian Health Survey shows that the combined oral contraceptive pill is the most commonly used form of contraception. However, the Pearl index of Long-acting reversible contraceptive (LARC) methods is significantly better (perfect and typical use \<0.5) compared to the combined oral contraceptive pill (perfect use \<1.0, typical use 2-9). An IUS is an example of a LARC method. IUS insertion might be painful. Because of this, women may be reluctant to opt for an IUS. The traditional technique for an IUS insertion uses a speculum after which a Pozzi tenaculum is placed on the cervix so that the uterus is brought into the stretching position by means of traction. The cavum is then measured by a uterine sound. These actions and the use of these instruments can contribute to the pain experience during insertion. The new technique, transabdominal sonographic (TAS) insertion, could reduce the pain experience during insertion. This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings. Little high quality studies have been conducted on the advantages and disadvantages of the TAS technique as demonstrated by a non-published systematic review of the literature. Research question/goal: Is the insertion of an IUS (Kyleena/Mirena) using the TAS technique less painful than the traditional technique? Study design: A randomized trial (RCT) in which the subject is blinded to the insertion technique. Study population: Women wishing an IUS (Kyleena \& Mirena) Primary and secondary outcomes: The primary outcomes are the pain during insertion (Numeric Rating Scale (NRS) score 0-10) and dislocation: non-fundal position (\> 3mm fundal distance postinsertion) in the uterine cavity (Y/N). Secondary outcomes include the average and worst pain in the first week after insertion (NRS 0-10), expulsion of the IUS, perforation of the uterine wall, failure of insertion, the occurrence of vagal symptoms, use of pain relief the first 7 days after placement, subject satisfaction about the procedure, successful IUS placement.
Interventions
- Procedure IUS (intrauterine system) insertion
Intra-uterine device insertion (technique based on randomization arm)
Primary outcome measures
- Pain during insertion of the IUS [Time frame: From enrollment to the intervention date (IUS placement)]
- Dislocation [Time frame: From enrollment to intervention date (IUS placement)]
Secondary outcome measures (8)
- Expulsion [Time frame: During of directly after the intervention (IUS placement)]
- Failure of insertion [Time frame: During the procedure of IUS placement]
- vagal symptoms [Time frame: During IUD insertion]
- Pain experience during 7 days after placement [Time frame: During the 7 days after IUS insertion]
- Pain relief taken during the 7 days after IUS placement [Time frame: During the 7 days after IUS placement]
- Satisfaction with the procedure [Time frame: Seven days after IUS placement]
- Successful IUS placement [Time frame: Directly after IUS insertion procedure]
- Perforation [Time frame: During IUS placement]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Belgium · 1 center
- Ghent University Hospital — Ghent
Identifiers
NCT: NCT07315646 · ONZ-2025-0220