Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion (PAINLESS)

Ghent University Hospital (UZ)

Status: Not yet enrolling

Conditions: Intra-uterine Device Placement

Treatments: Procedure: IUS (intrauterine system) insertion

Study type: Interventional

Funder types: Other

Identifiers

NCT07315646

ONZ-2025-0220

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

The TAS (transabominal ultrasound) insertion technique

Experimental group

Description:

This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings.

Treatment:

Procedure: IUS (intrauterine system) insertion

The Traditional Technique

Active Comparator group

Description:

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.

Treatment:

Procedure: IUS (intrauterine system) insertion