Diagnostics of malposition and complaints in women with 52-mg LNG-IUS Urological and Genital Diseases
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Women who visited our clinic for the insertion of a 52mg LNG-IUS (Mirena®) for contraception or treatment of heavy menstrual bleeding 2. Over 18 years of age
Exclusion criteria
Exclusion criteria: 1. Presence of intracavitary polyps or fibroids on 2DUS prior to insertion 2. Unprotected intercourse one month prior to insertion if insertion took place outside menstruation 3. Women were excluded for analyses if no ultrasound was performed six weeks after insertion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of malposition on 2DUS during routine investigation six weeks after insertion | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical symptoms at six weeks: 1. Unacceptable bleeding pattern measured using a questionnaire 2. Pelvic pain measured using a 5-point Likert scale | — |
Countries
Netherlands