A Retrospective, Post-marketing Study of the Expulsion Rate, Efficacy and Satisfaction From Use of the IUB(TM) SCu300B MIDI Spherical Copper Intrauterine Device in Austria
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Expulsion rate
研究概览
简要总结
Participating investigators will locate all IUB B insertions conducted at their facility at least 12 month prior the initiation of study data collection. The study is composed of 2 parts. Part one is collecting data out of patient's medical record which is accessible only to the doctor. This data is mostly demographic. Part two of the study comprises a phone call to the patients done by the doctor or by authorized site personnel. In the phone call the study purpose will be explained to the patient and a patient consent will be required. After the patients consent to participate, the doctor will ask the patient the questions defined in the study protocol regarding her experience during the time since the IUB SCu300B's insertion.
A total of 200 eligible subjects will be invited to participate in the study. Informed Consent Form will be signed and sent to the investigator, applicable CRFs will be completed by the investigator or authorized site personnel. The patient questionnaires will be asked on the telephone and entered directly into the CRF by the investigator or authorized site staff (CRF = source document). Also the physician´s questionnaire will be directly completed in the CRF by the investigator (CRF = source document). All other clinical data will be transcribed to the CRF from the medical patient records (patient records = source document).
There are no planned patient visits to the doctor's office for study purposes. If the patient visits the physician´s office as part of the clinical routine, the study procedures can also be performed directly at the site instead of telephone contacts.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 42 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult nulliparous, uniparous or multiparous females age 18 and over.
- •Free and willing to give information regarding their experience.
- •Given written informed consent.
排除标准
- •Enrollment in or planned to be enrolled in another study.
结局指标
主要结局
Expulsion rate
时间窗: 1 year
次要结局
- Complication rate including malposition, perforation and infection(1 year)
- Subject satisfaction: will be evaluated on a scale from 1 - 10 in a questionnaire (= case report from)(1 year)
- Adverse events (AE)(1 year)
- Pregnancy rate(1 year)
- Change in menstrual pattern before and after insertion of IUB SCu300B device on a scale from 1 - 10 in the questionnaire (= case report form)(Before and (at least) 1 year after the insertion of IUB SCu300B)
- Physician´s assessment on "ease of use" of IUB SCu300B: evaluated by the physician on a scale from 1-10 in the questionnaire (= case report form)(1 year)
- Discontinuation rate(1 year)
