STUDY RATIONALE
IUDs pose several complications to users, such as perforation during insertion, migration and expulsion. IUDs may also cause menorrhagia, discomfort and pain presumably due to distortion of the uterus by their semi-rigid polymeric frame.
A proof of concept study was concluded on the SCu300A (the first approved variant of the IUB™ product family) and published and a comparative study for the SCu300A is ongoing. The purpose of this current study is to obtain performance data on the SCu300B which is CE approved and commercially sold. Since the IUB B has a slightly larger diameter and stiffer frame than the SCu300A - to see if these parameters affect expulsion rate, efficacy and QOL.
This post marketing study aims to verify the IUB™'s SCu300B efficacy. Endpoints include 1 year Expulsion rate, as well as assessment of pregnancy rates, mal-position, perforation, discontinuation rates and physician and participant's satisfaction. These results will be used and will also help in reaffirming the assumption that the IUB™'s design contributes to lower complication and side effect rates.
RISK/BENEFIT ASSESSMENT
Clinical Benefits or risks:
Since this is a retrospective data collection, there will be no risks or benefits for participants. The participants will have a phone call to propose the opportunity to be part of the study. After full explanation of the study aims the patients willing to participate will either consent by phone or sign and e mail a written informed consent form.
RECRUITMENT PLAN
Patients will be recruited to this study by the Ob\\Gyn physicians participating in the study. The doctors will address their medical files to allocate patient who has been inserted with an IUB B at least 12 month before data collection begins. At first - only contact information will be found and no other clinical data will be taken out of patient's files.
A phone call to the patient will be done in which the patient will generally be asked if she is willing to participate in a retrospective study. If the patient is willing, the informed consent form will be sent to the patient together with an explanation letter and a pre-addressed envelope per regular mail. If the patient is willing to participate and has sent back the signed informed consent form, the investigator or authorized site staff will call the patient, educate the patient about the research proposal on the phone and ask if there are any questions to be addressed. After all questions are answered the doctor will countersign the ICF.
In the same phone call the patient will be asked the protocol defined questions regarding the past year of IUB use.
STUDY OBJECTIVES
The objective of the proposed study is to evaluate the performance of the IUB™ SCu300B device in clinical use. In particular, the study will:
1. Evaluate the safety and performance of the IUB™ by means of objective clinical measures and in particular 1 year expulsion rates, perforation and pregnancy rates.
2. Evaluate the usability and patient satisfaction of the IUB™ in terms of physician as well as patient satisfaction for ease of insertion and subject QOL report questions.
