An observational study on the follow up of patients who had insertion of mirena

OBJECTIVES: To follow up the patients, who had insertion of Mirena (Levonorgesterel intrauterine System) from 2007 and 2011, and to determine the effectiveness in decreasing the menstrual blood loss and pain after one year of insertion of Mirena ; To assess the quality of life at the end of one year after insertion and satisfaction among the patients. METHODS: The qualitative improvement in menorrhagia was assessed using the Uterine Fibroid Symptom and Health related Quality of life questionnaire (UFS-QoL); The general quality of life at the end of one year was followed up by the SF 36 questionnaire; The improvement in pain was assessed by the Visual analogue scale; The level of satisfaction was evaluated using the CGI- (global improvement item). Survival analysis was also done and the reason for removal compared by the Tarone-Ware method. Statistical analysis was done by a paired t test for continuous variables and the significance calculated. RESULTS: The total number of insertions from 2007 to 2011 were 353, out of which 177 patient could only be followed up. The rate of voluntary removal of Mirena was 10.7% and the expulsion rate was 20%. 68.9% of patients showed symptomatic improvement; the symptom severity and the health related quality of life before and one year after insertion of Mirena, improved and was statistically significant (p <0.01). Similarly the SF 36 showed high scores showing the better quality of life one year after insertion of Mirena. There was statistically significant reduction in pain one year after insertion of Mirena (p <0.01). 83.5% of patients were satisfied with Mirena; However the quantitative analysis of haemoglobin, before and one year after insertion of mirena, though showed some improvement, was not statistically significant. CONCLUSIONS: 1. The total number of patient who had insertion of Mirena, from 2007 to 2011, in Christian Medical College and Hospital were 353. 2. Though there was an improvement from mean preinsertion haemoglobin of 10.4 gm% to post insertion haemoglobin of 11.5 gm%, this improvement was not statistically significant . Hence the quantitative improvement could not be proved, statistically. 3. The qualitative analysis done before insertion and one year after insertion of Mirena, in those with menorrhagia, by the UFS-QoL questionnaire, showed that : a) The Symptom severity scoring by UFS-QoL, before and after insertion of Mirena , had an improvement, that was statistically significant. b) The health related quality of life analysed by UFS-QoL, before and after one year after insertion also improved significantly, and was statistically significant. 4. The effectiveness of Mirena in those with dysmenorrhea , before and after insertion of Mirena, analysed by the Visual analogue scale(VAS), showed that the mean change was 72.4%, and paired ‘t’ test, showed that the improvement was statistically significant. 5. The health related quality of life, analysed by the SF 36, at one year after insertion of Mirena, showed that the mean score was ‘High’, which defines a more favourable health state. 6. The level of satisfaction among those using Mirena, showed that 83.5% of patients were satisfied, out of which 68.2% of patients were very much satisfied. 7. Survival analysis showed that the median duration of Mirena removal was 6 months. If the patients had waited, with additional medical therapy, removal could have been avoided, and they would have improved, at the end of one year. Around 23.4% of patients had expulsion of Mirena.