Intra-uterine Device PlacementPAINLESSNCT07315646
Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion
A study testing IUS (intrauterine system) insertion in people with Intra-uterine Device Placement, run by University Hospital, Ghent at 1 site in Belgium.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Intra-uterine Device Placement
- What is being tested?
- IUS (intrauterine system) insertion
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Feb 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Trophoblastic disease
- Known cervical or endometrial carcinoma
- Patients who have the profession of midwife, nurse or doctor.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
Ghent University Hospital
Ghent, 9000
Clinical Trial Coordinator Clinical Trial Coordinator, +32 09 332 48 72, studieco.vrouwenkliniek@uzgent.be
About this study
Official title: 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?
Read more
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.
- Conditions
- Intra-uterine Device Placement
- Being tested
- IUS (intrauterine system) insertion
- Keywords
- intra-uterine device placement, TAS-technique, contraception use, uterine bleeding heavy, menopausal bleeding, family planning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IUS (intrauterine system) insertionProcedure or surgery
Intra-uterine device insertion (technique based on randomization arm)
| Study group | Role | What they receive |
|---|---|---|
| The TAS (transabominal ultrasound) insertion technique | Experimental | This new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings. Receives: Procedure: IUS (intrauterine system) insertion |
| The Traditional Technique | Active comparator | 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. Receives: Procedure: IUS (intrauterine system) insertion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain during insertion of the IUS
Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10
Measured: From enrollment to the intervention date (IUS placement)
Dislocation
Dislocation: non-fundal position (> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)
Measured: From enrollment to intervention date (IUS placement)
Secondary outcomes (8)
Expulsion
Expulsion of the IUS during the procedure (Y/N)
Measured: During of directly after the intervention (IUS placement)
Failure of insertion
Failure of insertion (yes/no)
Measured: During the procedure of IUS placement
vagal symptoms
Vagal symptoms: paillor, sweating, syncope (yes/no)
Measured: During IUD insertion
Pain experience during 7 days after placement
Pain experience (average and worst pain) during 7 days after placement (NRS 0-10)
Measured: 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))
Measured: During the 7 days after IUS placement
Satisfaction with the procedure
Subject satisfaction with the technique (5 point Likert scale)
Measured: Seven days after IUS placement
Successful IUS placement
Successful IUS placement (Y/N)
Measured: 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.
Measured: During IUS placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start11 Feb 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intra-uterine Device PlacementStudies of the same condition, open and under way.
- More trials run by University Hospital, GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Imelda Hospital, Bonheiden
- Responsible party
- Sponsor
- Investigators
- Steven Weyers, MD, PhD, Principal investigator, University Hospital, Ghent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315646
- Sponsor's protocol ID
- ONZ-2025-0220
- Acronym
- PAINLESS
- Status last verified
- Jul 2026
- First submitted
- 8 Dec 2025
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PAINLESS Study: Pain Associated wIth traditioNal Versus uLtrasound guidEd iuS (Intra Uterine System) inSertion
- ClinicalTrials.gov ID
- NCT07315646
- Acronym / sponsor ID
- PAINLESS / ONZ-2025-0220
- Conditions
- Intra-uterine Device Placement
- Keywords
- intra-uterine device placement, TAS-technique, contraception use, uterine bleeding heavy, menopausal bleeding, family planning
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University Hospital, GhentUniversity, hospital or other
- Collaborators
- Imelda Hospital, Bonheiden
- Study start
- 11 Feb 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The TAS (transabominal ultrasound) insertion technique | Experimental | Procedure: IUS (intrauterine system) insertionThis new technique uses transabdominal sonography during IUS placement. The placement under constant visualization eliminates the need for Pozzi tenaculum and uterine soundings. |
| The Traditional Technique | Active comparator | Procedure: IUS (intrauterine system) insertionThe 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IUS (intrauterine system) insertionIntra-uterine device insertion (technique based on randomization arm) | Procedure or surgery | The TAS (transabominal ultrasound) insertion technique, The Traditional Technique |
Primary outcome
Pain during insertion of the IUS
Time frame: From enrollment to the intervention date (IUS placement)
Pain during insertion, reported by the subject on a Numeric Rating Scale (NRS scale) 0-10
Dislocation
Time frame: From enrollment to intervention date (IUS placement)
Dislocation: non-fundal position (> 3mm fundal distance postinsertion) in the uterine cavity (Y/N)
8 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- R. Charafeddine, E. Braekman, L. Gisle, S. Drieskens. Gezondheidsenquête 2018: Seksuele gezondheid. Brussel, België: Sciensano Rapportnummer: D/2019/14.440/60. Beschikbaar op: www.gezondheidsenquête.beLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven Weyers, MD, PhD principal investigator
University Hospital, Ghent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IUS (intrauterine system) insertion in people with Intra-uterine Device Placement, run by University Hospital, Ghent at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Margot Van Geyte, MD (+329323044, margot.vangeyte@uzgent.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain during insertion of the IUS (time frame: From enrollment to the intervention date (IUS placement)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.