Mirena for treatment of polyps

The role of the Mirena Intrauterine Device(LNG-IUD) in the management of endometrial polyps – a case control study.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12618000677202

Enrollment

Registered

2018-04-26

Start date

2015-04-20

Completion date

2017-04-12

Last updated

2018-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Objective – To test the hypothesis that the LNG-IUD can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women. Design - We designed a case control study, in which premenopausal women who had a polyp diagnosed at outpatient hysteroscopy and had a LNG-IUD inserted were booked for GA hysteroscopy and polypectomy through the standard booking process. A contemporaneous control was taken sequentially from the outpatient hysteroscopy database to match the case. Results - A total of 39 patients were included in the study, with 19 in the exposed group and 20 in the control group. The mean age was 43.6 (SD = 5.6) and 43.2 (SD = 8.1) in the two groups, respectively. No difference was found in time interval between the two procedures in the intervention and control groups (mean 92 vs 84 days, p=0.73). However, the proportion of polyps present at second procedure was significantly higher in the control group (80% vs 37%; relative risk (RR) 2.17; 95% CI [1.16, 4.07]; p=0.0062). Conclusion – Our case control study found that the LNG-IUD can have a role in the treatment of polyps for women who have heavy menstrual bleeding. This is the first study to show regression of endometrial polyps post treatment with LNG-IUD by direct visualisation at hysteroscopy.

Interventions

To test the hypothesis that the LNG-IUD over a two month period by an endosurgical consultant(OB/GYN) can have a role in the treatment of endometrial polyps confirmed at outpatient hysteroscopy in premenopausal women. It is an intrauterine device that is inserted into the uterus It lasts 5years and released 20mcg of levonorgestrel daily In the study the mirena was kept in for two months until they went on to have an inpatient hysteroscopy.

Eligibility

Sex/Gender

All

Age

18 Years to 50 Years

Healthy volunteers

Inclusion criteria

Patients attending the MHW outpatient hysteroscopy clinic who were premenopausal, English speaking, over 18, with abnormal uterine bleeding and ultrasound findings suggestive of an endometrial polyp and no contraindications to the LNG IUD were approached for participation into the study. Patients who consented to participation and subsequently were proven to have an endometrial polyp on outpatient hysteroscopy were eligible for inclusion. Control group also had to meet the same eligibility criteria as above.

Exclusion criteria

Patients with an inadequate grasp of English, were less than 18 years old or had a medical contraindication to the LNG-IUD were not eligible for the study. Patients unable to give informed consent or declining participation into the study were excluded, underwent standard treatment and were not disadvantaged or delayed in any way.

Outcome results