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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Intra-uterine Device Placement
• Intervention / Treatment: Procedure: IUS (intrauterine system) insertion

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margot Van Geyte, MD; Phone Number: +329323044; Email: margot.vangeyte@uzgent.be
• Study Contact Backup: Name: Study team Gynaecology & Obstetrics UZ Gent; Phone Number: +32 9 332 48 72; Email: studieco.vrouwenkliniek@uzgent.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: The TAS (transabominal ultrasound) insertion technique; This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings.	Procedure: IUS (intrauterine system) insertion; Intra-uterine device insertion (technique based on randomization arm)
Active Comparator: The Traditional Technique; 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.	Procedure: IUS (intrauterine system) insertion; Intra-uterine device insertion (technique based on randomization arm)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dislocation	Dislocation: non-fundal position (> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)	From enrollment to intervention date (IUS placement)
Pain during insertion of the IUS	Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10	From enrollment to the intervention date (IUS placement)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Expulsion	Expulsion of the IUS during the procedure (Y/N)	During of directly after the intervention (IUS placement)
Failure of insertion	Failure of insertion (yes/no)	During the procedure of IUS placement
vagal symptoms	Vagal symptoms: paillor, sweating, syncope (yes/no)	During IUD insertion
Pain experience during 7 days after placement	Pain experience (average and worst pain) during 7 days after placement (NRS 0-10)	During the 7 days after IUS insertion
Pain relief taken during the 7 days after IUS placement	Pain relief taken during the 7 days after placement (Y/N, if yes specify in text field (what, dose, timing))	During the 7 days after IUS placement
Satisfaction with the procedure	Subject satisfaction with the technique (5 point Likert scale)	Seven days after IUS placement
Successful IUS placement	Successful IUS placement (Y/N)	Directly after IUS insertion procedure
Perforation	Perforation: IUS perforates the uterine wall (Y/N). Characterized by sharp pain and blood loss during insertion, ultrasound extrauterine position in total perforation or positioned in the myometrium in partial perforation.	During IUS placement

Collaborators and Investigators

• Sponsor: University Hospital, Ghent
• Collaborators: Imelda Hospital, Bonheiden
• Investigators: Principal Investigator: Steven Weyers, MD, PhD, University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Estimated): December 18, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: December 8, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: January 2, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: family planning; intra-uterine device placement; TAS-technique; contraception use; uterine bleeding heavy; menopausal bleeding
• Additional Relevant MeSH Terms: Pharmaceutical Preparations; Dosage Forms; Delayed-Action Preparations; Drug Implants
• Other Study ID Numbers: ONZ-2025-0220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No