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Endometrial thermoablation for treatment of menorrhagia: comparison of two methods in outpatient setting.

BACKGROUND: Menorrhagia is one of the commonest reasons for gynecologic consultations. Inhibitors of fibrinolysis and non-steroidal anti-inflammatory drugs (NSAIDs) are generally used as therapy for the condition with an acceptable response in some patients. Endometrial ablation is one choice in patients suffering from menorrhagia. It can be performed in patients with no endometrial histological or anatomical pathology. In this method, the functional endometrial tissue is ablated under general anesthesia in an outpatient setting. METHODS: We compared two methods that are widely used in Finland (Menotreat and Cavaterm) in thermoablation of endometrial tissue in 31 patients that were randomized into two treatment groups. RESULTS: Endometrial ablation was effective in the treatment of menorrhagia in patients with normal endometrial structure. About 70% of the patients described the result of the treatment as 'very good'. Only one patient underwent a hysterectomy during the 6-month follow-up period because of problems related to uterine bleedings. The two methods were similar in efficacy and patient acceptance. CONCLUSIONS: Both thermoablation techniques were well accepted by our patients and showed similar and good efficacy and patient acceptance.

Adult↗

Inherited bleeding disorders in Indian women with menorrhagia.

In order to define the prevalence of haemostatic defects in women presenting with menorrhagia in our region, the coagulation data on women bleeders investigated in the Department of Haematology, AIIMS, were analysed. A total of 337 of the 2200 menorrhagic women investigated were characterized to have an inherited bleeding disorder; 221 of these 337 women presented with menorrhagia alone while 116 also had other associated bleeding manifestations as prolonged bleeding from injury site, ecchymotic patches in the skin, epistaxis, haematomas, haemarthroses and major bleeds like intracerebral bleeding. The tests performed included bleeding time (BT), platelet count, prothrombin time (PT), prothrombin consumption index (PCI), activated partial thromboplastin time (APTT), PF3 release with adenosine diphosphate (ADP) at 0 and 20 min, total PF3 assay and platelet Aggregation studies with collagen, ADP, adrenaline, arachidonic acid and ristocetin. Coagulation factor assays, von Willebrand antigen estimation, ristocetin cofactor assay and electron microscopy were performed wherever necessary. Inherited platelet dysfunction was seen in 283 (83.9%) of the patients. Amongst these, isolated PF3 availability defect was seen in 163 (48.4%) cases. Glanzman's thrombasthenia was seen in 30 (8.9%) patients, Storage pool disease in eight (2.4%) patients, arachidonic acid pathway defect in five (1.5%) patients and Bernard-Soulier Syndrome in six (1.8%) patients. In 71 (21.1%) patients, the platelet function defect could not be classified into any specific subtypes. Inherited defects of coagulation were observed in 54 (16%) of the cases. Amongst these, von Willebrand disease (vWD) was the most frequent being seen in 40 (11.9%) of the cases. Factor XIII deficiency was seen in one (0.3%), factor X deficiency in four (1.2%), factor VII deficiency in one (0.3%) and factor XII deficiency in one (0.3%) of the patients. It is concluded that although hereditary platelet function defects constitute a large majority of women bleeders in India but among the coagulation defects, vWD is the commonest as reported from the caucasian population. It is thus suggested that in women presenting with menorrhagia, screening tests for haemostasis especially for vWD and inherited platelet function defects must be performed.

Adolescent↗

Endometrial resection for the treatment of menorrhagia.

BACKGROUND: Endometrial resection is an alternative to hysterectomy in the treatment of women with menorrhagia, but it may not control the condition. We sought to evaluate the effectiveness of such resection. METHODS: We followed 525 consecutive women (mean age at initial surgery, 42 years) for up to five years after endometrial resection. The women were examined 6 to 12 weeks after the operation and were then sent yearly questionnaires seeking information about their condition. The mean duration of follow-up was 31 months. Thirty-seven women (86 percent of the 43 women available for five years of follow-up) were followed for the entire period. RESULTS: Endometrial resection was completed successfully in 95 percent of the women, with operative complications in 6 percent. Forty-eight women underwent subsequent resection. The yearly questionnaires indicated that 85 to 100 percent of the women (depending on the year of follow-up) had adequately controlled menorrhagia, 26 to 40 percent had amenorrhea, 71 to 80 percent reported either a lessening of menstrual pain or no pain, and 79 to 87 percent were satisfied with the results of their surgery. No further surgery was needed by 80 percent of the women, and only 9 percent underwent hysterectomy during the five years of follow-up, with 98 percent of those operations being performed in the first three postoperative years. CONCLUSIONS: Endometrial resection is an effective alternative to hysterectomy in women with menorrhagia.

Adolescent↗

Hysteroscopic transcervical endometrial resection versus thermal destruction for menorrhagia: a prospective randomized trial on satisfaction rate.

OBJECTIVE: The purpose of this study was to compare the satisfaction rate and the effectiveness of transcervical hysteroscopic endometrial resection and thermal destruction of the endometrium in the treatment of menorrhagia. STUDY DESIGN: A prospective randomized trial with 2 years of follow-up was carried out in the Department of Gynecology of the University of Naples. Eighty-two patients who were affected by menorrhagia that was unresponsive to medical treatment were respectively randomized to transcervical hysteroscopic endometrial resection or to thermal destruction of the endometrium. Satisfaction rate, operative time, discharge time, complication rate, reintervention rate, and resumption of normal activity were evaluated in each group. RESULTS: The satisfaction rate was significantly higher in the thermal destruction group. Operative time was significantly shorter in the thermal destruction group (24 +/- 4 minutes vs 37 +/- 6 minutes). Intraoperative blood loss was significantly lower in the thermal destruction group (7.2 +/- 2.8 mL vs 89 +/- 38 mL). Reintervention rates were higher in the transcervical hysteroscopic endometrial resection group, although postoperative pain was not significantly different between the two groups. Discharge time, complication rate, and resumption of normal activity were not significantly different between the two groups. CONCLUSION: Thermal destruction of the endometrium for the treatment of menorrhagia should be considered an effective therapeutic option because of its acceptability among patients, shorter operative time, and lower blood loss.

Adult↗

Assessment of menorrhagia by total menstrual fluid loss.

Half of the women presenting with heavy periods do not have objective menorrhagia. In the normal woman, blood is a minority component of total menstrual volume. This paper was designed to examine the hypothesis that the volume of total menstrual fluid loss (TMFL) could be more important than blood loss. A total of 115 women complaining of menorrhagia performed a menstrual collection from which TMFL and menstrual blood loss (MBL) was derived. In women complaining of menorrhagia, mean total menstrual fluid loss is 183.5 ml, with a corresponding menstrual blood loss of 110.3 ml. There is a significant correlation between TMFL and MBL (r = 0.82 (95% CI 0.75 - 0.87), p < 0.001). Blood loss accounts for an average of 60.5% of the total menstrual fluid loss with a wide range of 20 - 99.8%. A change in the proportion of TMFL loss that is blood may well be part of the complex reasons why women present.

Blood↗

Is balloon ablation as effective as endometrial electroresection in the treatment of menorrhagia?

BACKGROUND: Hot-fluid balloon therapy is a recently introduced, relatively simple endometrial ablation procedure for menorrhagia. Because it is thought to be safer than other ablation procedures, it would be superior to other types of ablation if it is equally effective. The purpose of the present study was therefore to compare the safety and effectiveness of balloon ablation and transcervical resection of the endometrium (TCRE) for the treatment of menorrhagia. PATIENTS AND METHODS: We performed a prospective cohort study comparing TCRE and hot-fluid balloon ablation in consecutive patients suffering from menorrhagia and not responding to medical treatment. Between 1992 and 1994, all patients had TCRE, whereas from 1995 onward, all patients had balloon therapy. Outcome measures were surgical reintervention, menstrual pattern, and patient satisfaction. Assuming a 9% reintervention rate after TCRE, a series of 150 patients was required to show balloon ablation to be equally effective. RESULTS: Of the 152 patients who were included, 75 underwent TCRE and 77 had balloon ablation. The procedure had to be abandoned in 13 patients in the TCRE group (17%) and in 8 patients in the balloon ablation group (10%). In the TCRE group, four patients underwent a second resection, whereas hysterectomy was performed in 15 patients (3-year cumulative reintervention rate 26%). In the balloon-ablation group, there were no reresections, whereas hysterectomy was performed in 9 patients (3-year cumulative reintervention rate 13%) (log-rank test P = 0.11). The relative risk for any reintervention was 0.36 (95% confidence interval 0.05-2.5). At 3 months' follow-up the duration of menstruation was significantly shorter after TCRE than after balloon ablation, but at 6, 12, and 24 months, the duration of menstruation in the two groups appeared to be equal. No difference in patient satisfaction could be detected between the two groups, but there appeared to be a statistically significant decline in patient satisfaction over time for both therapies. This decline was stronger after TCRE than after balloon ablation. CONCLUSIONS: Because endometrial ablation with a hot-fluid balloon seems to be as effective as endometrial resection, with a lower complication rate, balloon ablation might become the procedure of choice for endometrial ablation.

Adult↗

Economic evaluation of three surgical interventions for menorrhagia.

BACKGROUND: The study was carried out to compare the overall effectiveness and direct economic costs of vaginal hysterectomy (VH), endometrial ablation (EA) and thermo-coagulation (TC) for the treatment menorrhagia. METHODS: We treated 50, 50 and 47 women with menorrhagia (>150 points on the Higham pictorial chart) by VH, EA and TC respectively. The patients were treated consecutively by the same surgeon and the choice between the three procedures depended on the desire of the patients. Resource utilization for the interventions was collected retrospectively from the hospital charts. A study questionnaire was mailed to the patients 24-36 months after the primary surgery. Patients who reported that they had undergone a second procedure or who were still menorrhagic were considered as treatment failures. RESULTS: As expected, the failure rate was lowest for VH. The total cost (without re-intervention for persistent menorrhagia) was 5315 Euros for VH, 1098 Euros for EA and 921 Euros for TC. The total cost with re-intervention was calculated based on therapeutic strategies used in 2001 and estimated at 5321 Euros for VH, 1263 Euros for EA and 1320 Euros for TC. CONCLUSIONS: The two out-patient procedures are very comparable in terms of success rates and costs. Choices will depend on budgeting considerations, surgeon skill and patient preference. The results may give guidance to investment decisions.

Adult↗

A cost-utility analysis of hysterectomy, endometrial resection and ablation and medical therapy for menorrhagia.

BACKGROUND: Four types of treatment [hysterectomy, endometrial resection/ablation, levonorgestrel-releasing intrauterine system (LNG-IUS) and oral medical therapy] are available for management of menorrhagia. The objective of this study was to compare the cost and quality-adjusted life-years (QALYs) gained by these four treatment alternatives. METHODS: A Markov model was designed to simulate the healthcare resource utilization and QALYs of the four treatment alternatives for patients presenting with menorrhagia over 5 years. Clinical inputs were estimated from literature, and the cost analysis was conducted from the perspective of healthcare provider in Hong Kong. RESULTS: The base-case analysis showed that the hysterectomy group was the most effective (4.725 QALYs) alternative with the highest cost (USD6878, 1USD=7.8HKD). The incremental cost per additional QALY (ICER) gained by hysterectomy was USD23 500. The probability of extra surgery in the endometrial resection/ablation was an influential factor. Probabalistic sensitivity analysis of 10,000 simulations of the Monte Carlo model showed that the hysterectomy group gained higher number of QALYs than the LNG-IUS, oral medical treatment and endometrial resection/ablation groups, 99, 99 and 98% of the time, and it was more costly than the other three groups over 85% of the time. CONCLUSIONS: Hysterectomy appears to be cost effective, with ICER less than USD50,000, for management of menorrhagia.

Adult↗

The surgical management of menorrhagia.

Surgical treatment of menorrhagia is likely to be both successful and satisfactory to the patient. Correct diagnosis of the cause of menorrhagia is essential, and management should be directed to the specific cause of the problem. The question of which treatment is best is a complex one and involves balancing patient wishes, expected outcomes, complications, cost-effectiveness and quality of life issues. For the subset of women in whom dysfunctional uterine bleeding is diagnosed, the literature suggests that there is a hierarchy of treatments that, in descending order for both efficacy and patient acceptability, are: (i) hysterectomy; (ii) endometrial ablation (either first- or second-generation); (iii) the levonorgestrel intrauterine system; and (iv) medical treatments. All four of these options should be discussed with the patient and the relative advantages and disadvantages considered before a treatment decision is made. For patients in whom a pathological cause is diagnosed, specific treatments should be aimed at removal of the lesion and observation of the effect on menstrual status. In addition to the treatment options above, specific treatments such as hysteroscopic, laparoscopic or open excision of the lesion need to be considered. For interventional radiological procedures such as uterine artery embolization, further study is recommended before it can be considered as a safe and effective treatment for menorrhagia.

Arteries↗

Endometrial vascular smooth muscle oestrogen and progesterone receptor distribution in women with and without menorrhagia.

This study tested the hypothesis that alterations in the expression of oestrogen and progesterone receptors (ER and PR) in endometrial vascular smooth muscle cells (VSMC) may play a role in the increased blood loss that occurs during menorrhagia. Subject groups were: controls (n = 40), those with menorrhagia (menstrual blood loss > 80 ml, n = 39) and patients post-endometrial ablation (n = 16). The aims of our study were to describe the changing distribution of VSMC ER and PR during the menstrual cycle and to look for differences between the three groups. Immunohistochemical double-staining results for VSMC and either ER or PR were highly varied, with 0-85% of endometrial arterioles in a biopsy section having alpha smooth muscle actin/ER positive cells, and 0-70% demonstrating PR. There were no significant differences between controls, menorrhagia or post-ablation specimens (analysis of variance for ER P = 0.72; for PR P = 0.17). There were also no significant differences between the different stages of the menstrual cycle when all three groups were combined (analysis of variance for ER P = 0.11; for PR P = 0.13). The high variability found in this study may mask biologically relevant differences in endometrial vascular ER and PR distribution between different groups.

Adult↗

The morphologic characteristics of menstrual hemostasis in patients with unexplained menorrhagia.

The endometrium in uteri removed by hysterectomy in patients with unexplained menorrhagia was compared with the endometrium in patients with normal menstruation who had a hysterectomy for uterine prolapse. The vascular ultrastructure and hemostatic plug formation were examined from the late secretory phase throughout menstruation to day 9 of the proliferative phase of the menstrual cycle. Endothelial defects, with and without hemostatic plugs, were more common and were present longer in the endometrial blood vessels of patients with unexplained menorrhagia than in patients with normal menstruation. In normal menstruation, no vascular defects were observed after day 3 of the cycle, whereas vascular defects were observed up to day 9 in the blood vessels of patients with unexplained menorrhagia. These morphologic features are likely to play a major role in the increased menstrual bleeding in such patients without uterine pathologic findings.

Adult↗

Modern treatments of menorrhagia attributable to dysfunctional uterine bleeding.

Menorrhagia (excessive uterine bleeding) affects some 20 percent of the women of reproductive age worldwide. The following review describes known and theorized etiologies of the disorder, followed by a discussion of treatment options that are currently in use as well as those on the horizon. There is much interest internationally in decreasing hysterectomy rates, particularly for those women with abnormal bleeding and anatomically normal uteri. It is these women who are the focus of this paper. Pharmacotherapy and surgery are the mainstay treatments for such patients with menorrhagia secondary to dysfunctional uterine bleeding. Most commonly, hormonal and nonhormonal medications are followed by dilatation and curettage, and ultimately, in many cases, hysterectomy. Endometrial ablation techniques have been evolving since the 1980s in response to the need for an efficacious, safer, and more cost-effective alternatives to hysterectomy. Hysteroscopic ablation achieves these goals but is difficult technically and requires significant additional training even for otherwise skilled and experienced gynecologists. The current decade has seen the development of many innovative approaches to performing endometrial ablation. These methods are intended to be much simpler to perform with less risk than electrosurgical or laser endometrial ablation. The final section of this article presents the published data to date on these new technologies, which should (in their refined state) revolutionize the treatment of menorrhagia secondary to dysfunctional uterine bleeding.

Endometrium↗

Long-term treatment of menorrhagia with levonorgestrel intrauterine system versus endometrial resection.

OBJECTIVE: The purpose of this study was to compare the long-term efficacy of the levonorgestrel intrauterine system and transcervical resection of the endometrium in the treatment of menorrhagia. METHODS: This study was an open, randomized 3-year trial. Patients with menorrhagia were assigned randomly to either the levonorgestrel intrauterine system (n = 30) or endometrial resection (n = 29). Pictorial blood loss assessment charts were used to measure menstrual blood loss. A pictorial blood-loss assessment chart score exceeding 75 (representing menstrual blood loss >/=60 mL) was used to diagnosis the patient as having menorrhagia. Discontinuations and cases requiring repeat operations were evaluated. RESULTS: Pictorial blood loss scores decreased from a baseline median of 261.5 (range, 60-1503) to 7 (range, 0-101; P < .001) for the levonorgestrel intrauterine system and from 311 (range, 81-2506) to 4 (range, 0-182; P < .001) for transcervical resection of the endometrium. Nineteen women of 30 using the levonorgestrel intrauterine system completed the 3-year follow-up compared with 22 of 29 for transcervical resection of the endometrium. CONCLUSION: Both treatments efficiently reduced menstrual bleeding. The high continuation rate suggests that the levonorgestrel intrauterine system is comparable with transcervical resection of the endometrium.

Adult↗

A multi-centre collaborative study into the treatment of menorrhagia by Nd-YAG laser ablation of the endometrium.

OBJECTIVE: To determine the safety and clinical effectiveness of Nd-YAG laser ablation of the endometrium in the treatment of menorrhagia. DESIGN: A prospective 3-year observational multi-centre study. SETTING: Gynaecological units in the UK and USA with special interest in endoscopic laser surgery. SUBJECTS: 859 women with menorrhagia resistant to medical therapy. MAIN OUTCOME MEASURE: Duration of laser ablation, intra- and post-operative complications, amenorrhoea rate, oligomenorrhoea rate, and woman's subjective assessment of treatment. RESULTS: No major complications occurred in 859 treatments. Four (0.4%) cases of transient fluid overload, 4 (0.4%) of infection, and 3 (0.3%) of uterine perforation occurred. Each of the perforations occurred during insertion of the rigid instruments and none was produced by the laser. There were no major haemorrhages, no blood transfusions were needed, and no woman required a laparotomy. The mean duration of the laser ablation was 24 min, and the average stay in hospital was less than 24 h. Of the 479 women followed up for at least 6 months after treatment 288 (60%) developed complete amenorrhoea and 152 (32%) reported continuing but satisfactorily reduced menstruation; 39 (8%) failed to improve with the first treatment, but 26 of them responded to a second laser ablation. Overall 466 (97%) had a satisfactory response to laser ablation and only 13 (3%) required subsequent hysterectomy. CONCLUSION: Endometrial laser ablation would appear to be a popular, safe, effective and economical alternative to hysterectomy for the treatment of menorrhagia.

Adult↗

A review of 80 endometrial resections for menorrhagia.

OBJECTIVE: To assess the efficacy of endometrial resection in treating menorrhagia. DESIGN: A clinical audit of 80 consecutive patients. SETTING: The department of gynaecology, Ealing Hospital, London. SUBJECTS: Eighty women referred by their general practitioner with the primary complaint of menorrhagia. INTERVENTIONS: Endometrial resection by hysteroscopic electro-diathermy. MAIN OUTCOME MEASURES: Subjective assessment of the change in menstrual blood loss by the 75 patients, who were followed up for at least one year. RESULTS: Of 75 women assessed after 1 year 45 (60%) had a successful outcome and nine (12%) had 'some improvement'. There were 21 failures; 14 reported 'no improvement' initially and seven were late failures after a good result at 6 months. Fifteen underwent a second procedure with 83% success at 6 months. Complications included uterine perforation in three women, excessive glycine absorption in two, and two women had problems with haemorrhage. Four women came to hysterectomy. CONCLUSIONS: Endometrial resection is an effective treatment for menorrhagia. Improvements in operative technique and equipment gave better results and fewer complications in the second half of the series.

Adult↗

Endometrial sex steroid receptor expression in women with menorrhagia.

OBJECTIVE: To investigate the oestrogen and progesterone receptor distribution in endometrium from reproductive age and perimenopausal women with and without menorrhagia. DESIGN: A comparative observational study. SUBJECTS: Forty-five women with objective menorrhagia (27 categorised as reproductive age and 18 as perimenopausal) and a control group of 44 women (31 reproductive age and 13 perimenopausal) with menstrual blood loss of less than 80 ml per period. MAIN OUTCOME MEASURES: Oestrogen receptor and progesterone receptor semi-quantitative immunostaining scores. RESULTS: Comparison of control and menorrhagic endometrium in this study (whether from reproductive age or perimenopausal subjects) failed to demonstrate any major differences in either sex steroid receptor mean immunostaining score. The results demonstrated a great degree of variability in sex steroid receptor immunoreactivity between individuals. Irrespective of clinical group, significant increases in immunostaining were demonstrated in the proliferative phase of the cycle for immunoreactivity of oestrogen receptor in glands (P < 0.0005), and stromal (P = 0.002) compartments of endometrium and progesterone receptor immunoreactivity in glands (P = 0.009). Progesterone receptor immunostaining in the stromal compartments did not significantly decline (P = 0.06) in the secretory phase. CONCLUSIONS: Endometrium from women with objective evidence of menorrhagia is indistinguishable in terms of sex steroid immunoreactivity from endometrium of women with normal monthly blood loss. This pattern of sex steroid receptor immunostaining pattern was maintained into the perimenopausal years.

Adult↗

Endometrial ablation in the treatment of menorrhagia.

A prospective 5-year multicentre study, involving three UK gynaecology centres with a special interest in endoscopic laser surgery, was set up to determine the safety, acceptability, clinical effectiveness and complications of neodymium yttrium-aluminium-garnet laser ablation of the endometrium in the treatment of menorrhagia. A total of 2342 women with disabling menorrhagia that was unresponsive to medical therapy were involved. The main outcome measures were: preoperative endometrial preparation; duration of laser ablation, intra- and postoperative complications, amenorrhoea rate, oligomenorrhoea rate, and the women's subjective assessment of treatment. No major complications occurred in the 2342 treatments. Nine (0.4%) cases of transient fluid overload, 11 (0.5%) of infection and five (0.2%) of uterine perforation occurred. None of the women required a laparotomy. The mean duration of the laser ablation was 24 min. The post-surgery amenorrhoea rate was higher in women pretreated with danazol. Of the 1866 women followed up for at least 1 year after treatment, 1043 (56%) developed complete amenorrhoea, 701 (38%) reported continuing but satisfactorily reduced menstruation, and 122 (7%) patients failed to improve with the first treatment (57 of these 122 women responded to a second laser ablation). Overall, 1744 (93%) had a satisfactory response to laser ablation and only 33 (1.8%) required subsequent hysterectomy. In conclusion, this study showed that hysteroscopic endometrial laser ablation is an acceptable alternative to hysterectomy for the treatment of menorrhagia.

Adolescent↗

Randomised comparative trial of the levonorgestrel intrauterine system and norethisterone for treatment of idiopathic menorrhagia.

OBJECTIVE: To compare the efficacy and acceptability of the levonorgestrel intrauterine system and norethisterone for the treatment of idiopathic menorrhagia. DESIGN: A randomised comparative parallel group study. SETTING: Gynaecology outpatient clinic in a teaching hospital. PARTICIPANTS: Forty-four women with heavy regular periods and a measured menstrual blood loss exceeding 80 ml. METHODS: Twenty-two women had a levonorgestrel intrauterine system inserted within the first seven days of menses, and 22 women received norethisterone (5 mg three times daily) from day 5 to day 26 of the cycle for three cycles. MAIN OUTCOME MEASURES: The main outcome measure was the change in objectively assessed menstrual blood loss after three months of treatment. RESULTS: When menstrual blood loss at three months was expressed as a percentage of the control, the levonorgestrel intrauterine system reduced menstrual blood loss by 94% (median reduction 103 ml; range 70 to 733 ml), and oral norethisterone by 87% (median reduction 95 ml; range 56 to 212 ml). After three cycles of treatment 76% of the women in the levonorgestrel intrauterine system group wished to continue with the treatment, compared with only 22% of the norethisterone group. CONCLUSIONS: Both the levonorgestrel intrauterine system and oral norethisterone in this regimen provided an effective treatment for menorrhagia in terms of reducing menstrual blood loss to within normal limits. The levonorgestrel intrauterine system was associated with higher rates of satisfaction and continuation with treatment, and thus offers an effective alternative to currently available medical and surgical treatments for menorrhagia.

Adult↗