Scholarly article on topic 'Are women satisfied when using levonorgestrel-releasing intrauterine system for treatment of abnormal uterine bleeding?'

Are women satisfied when using levonorgestrel-releasing intrauterine system for treatment of abnormal uterine bleeding? Academic research paper on "Clinical medicine"

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Academic research paper on topic "Are women satisfied when using levonorgestrel-releasing intrauterine system for treatment of abnormal uterine bleeding?"

ORIGINAL ARTICLE

Are women satisfied when using levonorgestrel-releasing intrauterine system for treatment of abnormal uterine bleeding?

Nina Mansukhani, Jyothi Unni, Meenakshi Dua1, Reeta Darbari2, Sonia Malik1, Sohani Verma3, Sonal Bathla4

Department of Obstetrics and Gynecology, Jehangir Hospital, Pune, Maharashtra, 'Infertility and IVF, Southend Fertility and IVF Centre, Holy Angels Hospital, Vasant Vihar, New Delhi, 2Artemis Hospital, Gurgaon, Haryana, 3Obstetrics and Gynecology, Indraprastha Apollo Hospital, Sarita Vihar, 4Sant Parmanand Hospital, Civil Lines, New Delhi, India

ABSTRACT

Aim: To determine the efficacy of levonorgestrel intrauterine system (LNG IUS) in treatment of abnormal uterine bleeding (AUB) in women over 35 years and to determine satisfaction of users of LNG IUS in case of AUB. Materials and Methods: This was a multicentric, retrospective, and observational study. Case records of patients with AUB from the hospitals in Pune, Delhi, and Gurgaon for the last 6 years were examined. Records of 80 women who had an LNG IUS inserted were included. The chief complaints and their duration were recorded. Investigation results, histopathology reports, and date of LNG IUS insertion were noted. The incidence of spotting, heavy menstrual bleeding, pain, expulsion, and amenorrhea were recorded at 3, 6, 12, and 18 months following treatment. Following this a telephonic interview was conducted to determine the efficacy of LNG IUS in treating the symptoms. Patients' satisfaction in percentage was also noted and they were asked if they would recommend the LNG IUS to other women.

Results: The mean age of women was 42.3 years. 77.5% of the women had menorrhagia as the chief complaint, and the mean duration was 12 months. Fibroids and adenomyosis were the most common pathology, present in 21.3% and -20% of the patients respectively. At 3 months, spotting seemed to be the predominant symptom (59.4%) and only 15% women had heavy bleeding. 49.3% of women were asymptomatic at 6 months. 27.5% had amenorrhea by the end of 18 months. 14 women in whom the device was expelled or removed due to persistent symptoms, underwent hysterectomy at various stages during the study period. Overall patient satisfaction was high at about 80%. Furthermore, 73.8% patients agreed to recommend it to other women. Conclusion: LNG IUS seems to be a viable and effective treatment option for AUB in women after 35 years. There is a high rate of patient satisfaction in appropriately selected patients.

Key Words: Menorrhagia, non-surgical options, peri-menopausal women

INTRODUCTION

Abnormal uterine bleeding (AUB) is the commonest symptom among women of reproductive age group presenting to the gynecologic out-patient department (OPD). Many women may present, after many years of suffering in silence. Once menopause sets in, this is known to resolve. Women, therefore, need some therapy to tide over this difficult time. Although, there are several hormonal and non-hormonal medications for treatment,

some have serious side-effects while others are unpopular because they are ineffective and temporary in nature.[1] Many women, therefore, resort to hysterectomy due to lack of compliance and low efficacy of the medication much against their desire. There has been a constant search for a suitable alternative to hysterectomy that can tide over this midlife problem until the woman attains menopause.

Address for Correspondence: Dr. Nina Mansukhani, S-3, 708, Ganga Satellite, Wanowrie, Pune - 411 040, Maharashtra, India. E-mail: mansukhaninina@gmail.com

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Quick Response Code: Website: www.jmidlifehealth.org

DOI: 10.4103/0976-7800.109633

Levonorgestrel intrauterine system (LNG IUS) is one such feasible option in these women. It is known to reduce the amount of bleeding by over 90% due to its continuous progestogenic effect on the endometrium.121 LNG-IUS has also been used in patients having fibroids,[3] adenomyosis[4] and endometriosis.[5] Such usage can reduce the need for hysterectomy, with its morbidity, and mortality. Here, we endeavored to study the satisfaction among users of LNG IUS in terms of reduction in symptomatology.

Statistical analysis

Statistical analysis was carried out by using SPSS 13. P< 0.5 was taken as significant. Results were obtained using frequencies, cross tabs and Chi-square test.

RESULTS

Out of a total of 80 patients in our study, majority of the women belonged to the age group between 35 and 40 followed by 41-45. The mean age of women in this study was 42.3 years.

1. To determine the efficacy of LNG IUS in treatment of AUB in women over 35 years.

2. To determine the satisfaction of users of LNG IUS in case of AUB.

MATERIALS AND METHODS

This was a multicentric, retrospective, and observational study. Case records of patients with the AUB presenting to Gynecology OPD of hospitals in Pune, Delhi, and Gurgaon for the last 6 years were examined. Women over 35 who had an LNG IUS inserted for AUB were included in the study. Records of 80 women who fulfilled the inclusion criteria were scrutinized for the chief complaints, duration of complaints, and ultrasound findings. Complete blood count, Thyroid Stimulating Hormone TSH levels, and Pap smear if carried out were noted down. Women were excluded from the study if they were found to have a uterus larger than 12 weeks as recorded in the case file, clinical suspicion of malignancy, adnexal masses, and pelvic inflammatory disease. Malignancy was excluded by clinical examination, cervical cytology, and endometrial sampling report. Histopathology reports and date of LNG IUS insertion was noted.

The incidence of spotting heavy menstrual bleeding, pain, expulsion, and amenorrhea were recorded at 3, 6, 12, and 18 months following treatment. Following this, telephonic interview was conducted to determine the efficacy of LNG IUS in treating the symptoms. Spotting was said to be present if patient needed to use sanitary protection following insertion of LNG IUS. Heavy menstrual bleeding was defined as passage of clots or use of double protection, soiling of underclothes despite using protection or passage of clots in toilet bowl. Amenorrhea was defined as complete absence of bleeding. A follow-up sonography report 6 months after LNG IUS insertion was noted down wherever it was performed, specifically with reference to the thickness of the endometrial lining and size of fibroid when present. Patients' satisfaction in percentage was also noted and she was asked whether she would recommend the LNG IUS to other women.

COMPLAINTS

Seventy seven percent of patients presented with menorrhagia. Average duration of complaints was 12 months [Figure 1].

ETIOLOGY

Pre-treatment ultrasound revealed fibroids and adenomyosis as the commonest pathology present in 21.3% and -20% of the patients respectively. This was followed by thick endometrium in 18.8%, probably denoting endometrial hyperplasia. 18.8% of women did not have any abnormal ultrasound finding, indicating dysfunctional uterine bleeding as the etiology. 5% of the women had endometriosis. Another 16% women had a bulky uterus on ultrasound.

Symptom relief

Evaluating symptomatic relief post-treatment we found that at 3 months, spotting seemed to be the predominant symptom (59.4%), and only 15% women had heavy bleeding. Twenty five percent of patients had significant reduction in bleeding and they felt significantly better (P = 0.00) [Table 1]. At 6 months, the number of women with spotting reduced considerably to 30.7% as did heavy bleeding, which reduced to 6.7%. Most patients (49.3%) were asymptomatic at 6 months.

Both spotting and heavy bleeding reduced remarkably by 12 months to 17.1% and 1.4% respectively and 22.9% patients had amenorrhea by this time. Amenorrhea rate went up to 27.5% by the end of 18 months.

□ Menorrhagia

■ Menometrorrhagia

□ Post menopausal bleeding

□ Menorrhagia + Dysmenorrhea

Figure 1: Frequency of symptoms

Patients symptoms were correlated with pathology detected on ultrasound. Table 2 shows how patients' symptoms improved gradually. Significant reduction in bleeding was noted in patients with adenomyosis. For 23 patients, histopathology report was not available.

Thirteen patients (56.8%) with simple hyperplasia without atypia had symptom relief by the end of 6 months whereas only 33% patients with proliferative endometrium had a reduction in bleeding. Patient with secretory endometrium did not respond to LNG IUS [Table 3].

Failure rate

In the present study, the expulsion rate was 7.5%, one of which happened during the 1st month after insertion, two within 3 months, two at 12 months and one at 18 months. It was found that patients with thick endometrium had maximum expulsion and removal of LNG IUS [Figure 2].

Table 1: Symptoms after LNG IUS insertion

Eight patients had to have the LNG IUS removed due to heavy bleeding or persistence of irregular and frequent bleeding/spotting at 18 months. All of them underwent hysterectomy.

□ Normal findings (n=20)

□ Endometriosis (n=5)

□ Thick endometrium (n=19)

I Adenomyosis (n=19)

□ Fibroids

Figure 2: Correlation of ultrasound pathology with expulsion/removal

Symptoms/ months

3 months «=79* (%)

6 months

«=75** (%)

12 months

«=70*** (%)

18 months

«=69**** (%)

P value

No complaints/ bleeding reduced

Spotting Heavy bleeding Amenorrhea

19 (24) 47 (59.4) 12 (15.2) 1 (1.2)

37 (49.3) 23 (30.7) 5 (6.7) 10 (13.3)

41 (58.6) 12 (17.1) 1 (1.4) 16 (22.9)

45 (65.2) 4 (5.8) 1 (1.5) 19 (27.5)

0.004 Significant

0.007 Significant 0.000 Significant

0.003 Significant

LNG IUS: Levonorgestrel-releasing intrauterine system

Table 2: Correlation of pathology with patient symptoms

Symptoms

(over 3, 6, 12, 18 months)

No complaints/ symptomatically improved

Spotting

Heavy bleeding

Amenorrhea

USG findings/number of patients 3 6 12 18 3 6 12 18 3 6 12 18 3 6 12 18

Fibroids (n=17) 6 7 8 10 8 7 5 2 3 1 1 1 0 1 2 3

Adenomyosis (n=19) 5 10 10 10 10 2 1 1 1 1 0 0 0 5 6 6

Thick endometrium (n=19) 4 9 10 9 13 6 4 1 1 1 0 0 0 0 0 3

Endometriosis (n=5) 2 2 3 3 2 1 0 011 0 0 0 1 1 1

Normal findings (n=20) 5 8 10 13 14 7 2 0 1 1 0 0 0 3 7 6

P value at 3 months=o.63/ P value at 6 months=o.48, P value at 18 months=o.8, USG: Ultrasonogi aphy

Table 3: Correlation of histopathology with patient symptoms

Symptoms No complaints/ Spotting Heavy bleeding Amenorrhea

(over 3, 6, 12, 18 months) symptomatically improved

Histopathology 3 6 12 18 3 6 12 18 3 6 12 18 3 6 12 18

Proliferative (n = 30) 4 10 16 19 22 12 5 3 4 3 1 0 4 6

Secretory (n = 1) 0 0 0 1 0 1 1 0 1 0 0 0 0 0 2 0

Simple hyperplasia without atypia (n=23) 5 13 15 17 15 6 3 0 2 1 0 0 0 1 1 3

Complex hyperplasia without atypia (n = 3) 0 1 2 1 3 1 0 0 0 0 0 0 0 1 0 2

For 23 patients, histopathology report was not available

Journal of Mid-life Health ! Jan-Mar 2013 ! Vol 4 ! Issue 1 33

Patient satisfaction

Patients who were found to have thick endometrium were most dissatisfied (60 ± 43; P = 0.04) and had maximum removal of LNG IUS [Table 4]. Patients with adenomyosis, bulky uterus, and normal ultrasound findings responded well to treatment and were highly satisfied (82%). These were the ones who would also highly recommend this treatment modality to other patients (more than 80%).

DISCUSSION

AUB is a common symptom among women of both reproductive age group and perimenopausal women. Fibroids, adenomyosis, and endometriosis are common gynecological pathologies causing AUB. Together with dysfunctional uterine bleeding these pathologies account for AUB which leads to loss of quality of life in many women and several times leads to a hysterectomy which itself is not without side effects and is many a time avoidable. LNG IUS is an effective and reversible treatment option for benign lesions causing menorrhagia, which has been well-documented in literature.[6,7]

LNG IUS reduces mean blood loss more than tranexemic acid, non-steroidal anti-inflammatory drugs, danazol, oral progestogens and combined oral contraceptives.[8]

Majority of the women in this study belonged to the reproductive age group as is expected for women with AUB. Since these women still have several years prior to menopause, it becomes relevant to offer them an effective and long-term option besides hysterectomy.

The predominant symptom seemed to be heavy blood loss and only a small number of women had dysmenorrhea, which is interesting because fibroids and adenomyosis were present in a total of 40% of women. Hence in both these categories it becomes apparent that the bleeding was the main reason for seeking medical help. This is comparable to that in a study by Robinson et alP]

Most of the women had actually suffered for a period of

Table 4: USG findings and satisfaction

USG findings Satisfaction (%) P value

mean±SD

70.3±3 0.25

82.3±30.4 0.25

60±43 0.04

69±41 0.68

82±24 0.37

USG: Ultrasonography

1 year prior to presenting in the OPD, which made it even more necessary for them to have an effective mode of treatment. Several women had in fact tried conservative medical methods of treatment including hormones during this period, with no relief.

LNG IUS seems to be an effective alternative for treatment of AUB related to fibroids. In a systematic review by Zapata et a/.,[10] it was revealed that most women with uterine fibroids using LNG IUS were likely to have less menstrual blood loss after insertion, despite some occurrence of irregular bleeding. LNG IUS may have higher rates of expulsion in these women compared to those without fibroids.

A study by Socolov et al..,[3] evaluating LNG IUS use in menorrhagia due to fibroids showed that 96% of the patients had achieved oligomenorrhea by 1 year.

We found in the present study that among women with fibroids, spotting seemed to be the predominant symptom at 3 months post-insertion (47%), and continued to be so at 6 months (41.1%). At 12 months, however, 47% of the women were symptom free and by 18 months majority of the patients (76.4%) were asymptomatic and actually achieved amenorrhea.

A total of 70.3% patients with fibroids in the present study were satisfied and 82.4% would recommend this treatment to other users. Similarly, in the study by Socolov et al,3 89% of women with fibroids considered LNG IUS as a good treatment.

The cases with adenomyosis seemed to respond very well and after the first 6 months most of the patients were asymptomatic (52.63%) and 26.3% had amenorrhea at 6 months and 31.57% at 12 months. Similar was the case with the thick endometrium group. This is comparable to the study by Cho et al.,[4] where 23% patients had amenorrhea by 12 months. Hence LNG IUS may be a suitable alternative to hysterectomy in adenomyosis.

In the endometriosis group, the number of patients was insufficient to comment definitely on improvement of symptomatology.

In the group with no ultrasound abnormality (dysfunctional uterine bleeding), it took 12-18 months to achieve symptomatic relief (50% at 12 months and 65% at 18 months).

On histological evaluation of the endometrium, most women had proliferative endometrium (37.5%) followed

Fibroids (^ = 17) Adenomyosis (n = 19) Thick endometrium (n = 19) Endometriosis (n=5) Normal findings (n=20)

by simple hyperplasia (28.75%) without atypia. Only 3 (3.75%) women had complex hyperplasia without atypia and 1 patient had a secretory endometrium.

Among the LNG IUS users in the endometrial hyperplasia group (simple and complex), 69.2% of the patients persisted to have spotting at 3 months and 65.3% had resolution of symptoms at 1 year.

In a study by Haimovich et al.,[11] there was 50% reduction in bleeding at 3 months and complete cessation of bleeding at 24 months in women with simple endometrial hyperplasia.

Expulsion/removal was compared with ultrasound findings. A total of six patients expelled the device and for eight, the LNG IUS was removed. Interestingly, expulsion or removal was not found to be related to uterine pathology (P = 0.132). This was found to be more in patients with menorrhagia and menometrorrhagia (P = 0.002).

LNG IUS had to be removed in six patients due to persistent heavy bleeding in spite of waiting for 3-12 months. And in the remaining two it was removed due to persistent spotting/bleeding at 18 months. All these patients opted to undergo hysterectomy.

The LNG IUS got expelled within 3 months of insertion for all 6 patients except one. She was 39 years old with fibroid uterus and menorrhagia. She had complete relief from her symptoms for 1 year. Her heavy bleeding returned after a year and at that time, the LNG IUS was found in the cervical canal.

Overall 74% of women would recommend the LNG IUS to other women for treatment of AUB.

CONCLUSION

LNG IUS seems to be a viable and effective treatment option for AUB in women after 35 years. There is a

high rate of patient satisfaction in appropriately selected patients.

REFERENCES

1. Shaw RW. Assessment of medical treatments for menorrhagia. Br J Obstet Gynaecol 1994;101:15-8.

2. Andersson JK, Rybo G. Levonorgestrel-releasing intrauterine device in the treatment of menorrhagia. Br J Obstet Gynaecol 1990;97:690-4.

3. Socolov D, Blidaru I, Tamba B, Miron N, Boiculese L, Socolov R. Levonorgestrel releasing-intrauterine system for the treatment of menorrhagia and/or frequent irregular uterine bleeding associated with uterine leiomyoma. Eur J Contracept Reprod Health Care 2011;16:480-7.

4. Cho S, Nam A, Kim H, Chay D, Park K, Cho DJ, et al. Clinical effects of the levonorgestrel-releasing intrauterine device in patients with adenomyosis. Am J Obstet Gynecol 2008;198:373,e1-7.

5. Vercellini P, Frontino G, De Giorgi O, Aimi G, Zaina B, Crosignani PG. Comparison of a levonorgestrel-releasing intrauterine device versus expectant management after conservative surgery for symptomatic endometriosis: A pilot study. Fertil Steril 2003;80:305-9.

6. Stewart A, Cummins C, Gold L, Jordan R, Phillips W. The effectiveness of the levonorgestrel-releasing intrauterine system in menorrhagia: A systematic review. BJOG 2001;108:74-86.

7. Desai RM. Efficacy of levonorgestrel releasing intrauterine system for the treatment of menorrhagia due to benign uterine lesions in perimenopausal women. J Midlife Health 2012;3:20-3.

8. Farquhar CM. Management of dysfunctional uterine bleeding. Drugs 1992;44:578-84.

9. Robinson R, China S, Bunkheila A, Powell M. Mirena intrauterine system in the treatment of menstrual disorders: A survey of UK patients' experience, acceptability and satisfaction. J Obstet Gynaecol 2008;28:728-31.

10. Zapata LB, Whiteman MK, Tepper NK, Jamieson DJ, Marchbanks PA, Curtis KM. Intrauterine device use among women with uterine fibroids: A systematic review. Contraception 2010;82:41-55.

11. Haimovich S, Checa MA, Mancebo G, Fuste P, Carreras R. Treatment of endometrial hyperplasia without atypia in peri- and postmenopausal women with a levonorgestrel intrauterine device. Menopause 2008;15:1002-4.

How to cite this article: Mansukhani N, Unni J, Dua M, Darbari R, Malik S, Verma S, et al. Are women satisfied when using levonorgestrel-releasing intrauterine system for treatment of abnormal uterine bleeding?. J Mid-life Health 2013;4:31-5.

Source of Support: Nil, Conflict of Interest: None declared.

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