NCT07315646: PAINLESS

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

Not yet recruiting NA Last updated 7 January 2026

What this trial tests

NA trial testing IUS (intrauterine system) insertion in Intra-uterine Device Placement in 50 participants. Not yet recruiting.

Timeline

18 December 2025

Primary endpoint
31 December 2026

31 December 2027

Quick facts

Lead sponsor	University Hospital, Ghent
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	50
Start date	18 December 2025
Primary completion	31 December 2026
Estimated completion	31 December 2027

Drugs / interventions tested

• IUS (intrauterine system) insertion

Conditions studied

• Intra-uterine Device Placement — all drugs for Intra-uterine Device Placement →

Sponsor

University Hospital, Ghent

Who can join

Adults 18 to 60, female only, with Intra-uterine Device Placement. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.