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A simple visual assessment technique to discriminate between menorrhagia and normal menstrual blood loss.

OBJECTIVE: To validate a simple, highly predictive test to discriminate between menorrhagia and normal menstrual blood loss. METHODS: The sanitary wear of 489 menstrual bleeding episodes was collected by 288 women for objective measurement of menstrual blood loss (alkaline hematin method); the women made a subjective assessment of the volume and, based on a pictorial chart, recorded the amount of and the degree to which their sanitary wear was soiled. Based on that degree, a score was calculated for each episode and a suitable cutoff point was chosen, above which the presence of menorrhagia was likely and below which it was unlikely. RESULTS: Using a score of 185 as the cutoff point, the predictive values of positive and negative tests were almost equally high, 85.9 and 84.8%, respectively. Whether or not the presence of clots was recorded, these values did not change. The predictive value of a woman's complaint of heavy bleeding for the presence of menorrhagia was 55.9% and that of anemia (hemoglobin less than 12.0 g/dL) was 74.4%. CONCLUSION: We validated and refined a new, simple, visual assessment technique and demonstrated that it is superior to a woman's subjective assessment of menstrual blood loss and the occurrence of anemia for predicting menorrhagia, even if it is performed only once. We also demonstrated that the volume that clots contribute to menstruation is not as large as many clinicians believe. With this technique, the quality of therapy can be enhanced by making it more adequate and rational.

Adult↗

Economic evaluation of hysteroscopic endometrial ablation versus vaginal hysterectomy for menorrhagia.

OBJECTIVES: To estimate society's expenses and benefits of hysteroscopic endometrial ablation and vaginal hysterectomy for the treatment of women with menorrhagia. METHODS: Between June 1992 and July 1993, 40 women with menorrhagia underwent vaginal hysterectomy by five surgeons in one hospital. These patients were compared retrospectively with the first 40 patients having had endometrial ablation for menorrhagia during the same period by the senior author (GAV). The age, parity, weight of patients, and uterine size were similar in both groups. Measurable variables that would incur costs included surgical time, procedure time (anesthetist and resource use in operating room), length of hospital stay, convalescence (value of patient time), and indirect costs associated with subsequent surgical procedures. Measurable benefits included reduction in blood loss and complications, and effectiveness of procedure. RESULTS: The total cost per episode of care was estimated to be $5373 and $2279 (1995 Canadian dollars) for vaginal hysterectomy and hysteroscopic endometrial ablation, respectively, a mean savings of $3094. The benefits derived from both procedures were comparable. Vaginal hysterectomy eliminated bleeding in 100% of patients and had a complication rate of 41%. Endometrial ablation eliminated or improved bleeding in 90% of patients (amenorrhea 46%, hypomenorrhea 35%, eumenorrhea 9%, no significant change 10%), was associated with no complications, and resulted in 82% patient satisfaction. CONCLUSION: Endometrial ablation is 82% effective and 58% less expensive than vaginal hysterectomy for the treatment of women with menorrhagia.

Adult↗

Therapeutic use of levonorgestrel-releasing intrauterine system in women with menorrhagia: a pilot study(1).

The objective of this study was to evaluate the efficacy and performance, for up to 1 year, of an intrauterine system releasing 20 microg/day of levonorgestrel (LNG-IUS, Mirena) in the treatment of women with menorrhagia. It was a descriptive, prospective, non-comparative study. A 20 microg/day LNG-releasing-IUS was inserted on any day during bleeding to 44 women (between 24 and 49 years of age) who presented with menorrhagia after medical therapies had failed. Menstrual patterns were assessed, and hemoglobin concentrations were measured before LNG-IUS was inserted and at 3, 6, 9, and 12 months of use. The most common bleeding pattern at 3 months after insertion was spotting, and after 6, 9, and 12 months the majority of women presented with amenorrhea or oligomenorrhea. Three women requested removal of the LNG-IUS because of spotting, and six women expelled it spontaneously. Hemoglobin levels were improved from 102 g/L to 123 and 128 g/L at 3 and 12 months, respectively, after insertion of the LNG-IUS (p < 0.01). At 12 months 79.5% of participants continued the use of LNG-IUS. In conclusion, LNG-IUS was an effective treatment for three out of four women with menorrhagia and could be an alternative treatment for women with menorrhagia who are either contraindicated for or refuse hysterectomy or endometrial ablation.

Adult↗

The effect of a levonorgestrel-releasing intrauterine device in the treatment of myoma-related menorrhagia.

In this open observational study we evaluated the effectiveness of a levonorgestrel-releasing intrauterine device (LNG-IUD) in the treatment of myoma-related menorrhagia. Nineteen patients with recurrent menorrhagia lasting more than 3 months and with fibromyomatosus uterus were treated for 12 months with a LNG-IUD releasing 20 micro g/day of levonorgestrel. Menstrual blood loss, measured objectively by the pictorial blood loss assessment chart score (PBAC), level of serum hemoglobin and pattern of uterine bleeding were recorded at 3, 6, 9 and 12-month follow-up visits. Median monthly PBAC score during the two menstrual cycles before treatment was 310. After LNG-IUD, the PBAC score gradually decreased from a median value of 186 at 3 months to a median value of 155, 108 and 96 at 6, 9 and 12 months of treatment, respectively. Despite the statistically significant reduction of PBAC score, persistent menorrhagia, defined as a monthly PBAC score of 100 or higher, was observed at 12 months in 14 patients, whereas only one woman was amenorrheic and 4 were hypomenorrheic. In conclusion our study demonstrates the clinical reduced effectiveness of LNG-IUD in the treatment of myoma-related menorrhagia.

Adult↗

Cost-effectiveness of transvaginal sonography and saline infused sonography in the evaluation of menorrhagia.

OBJECTIVES: To assess the cost-effectiveness of transvaginal sonography (TVS) and saline infused sonography (SIS) in the diagnostic work-up of women with menorrhagia. METHODS: We performed a decision analysis in which we compared the percentage of patients treated successfully and cost of six strategies for the evaluation of menorrhagia: (0) hormonal treatment, (I) treatment of all patients with balloon ablation, (II) TVS and therapeutic hysteroscopy, (III) TVS, SIS and therapeutic hysteroscopy, (IV) SIS and therapeutic hysteroscopy, and (V) diagnostic hysteroscopy and therapeutic hysteroscopy. Hormonal treatment was considered to be the reference strategy to which the five strategies were compared. Data were obtained from the published literature. In order to evaluate the robustness of our results, we performed extensive sensitivity analyses, in which we varied sensitivity and specificity of TVS and hysteroscopy, the prevalence of intracavitary abnormalities, as well as costs of TVS and SIS. RESULTS: We found that the strategy starting with SIS (IV) and the strategy with diagnostic hysteroscopy (V) revealed the highest number of patients treated successfully for menorrhagia. In terms of cost-effectiveness, SIS for all patients was superior over immediate diagnostic hysteroscopy for all patients. Strategies starting with TVS were less effective than the strategy starting with SIS. CONCLUSIONS: We recommend SIS as the procedure of first choice in the work-up for women with menorrhagia.

Catheter Ablation↗

Quality of life and cost-effectiveness of levonorgestrel-releasing intrauterine system versus hysterectomy for treatment of menorrhagia: a randomised trial.

BACKGROUND: Heavy menstrual blood loss is a common reason for women to seek medical care. The levonorgestrel-releasing intrauterine system (IUS) is an effective medical treatment for menorrhagia. We report a randomised comparison of this approach with hysterectomy in terms of the quality of life of women with menorrhagia and cost-effectiveness. METHODS: Of 598 women referred with menorrhagia to five university hospitals in Finland, 236 were eligible and agreed to take part. They were randomly assigned treatment with the levonorgestrel-releasing IUS (n=119) or hysterectomy (n=117). The amount of menstrual blood loss was objectively measured. The primary outcome measure was health-related quality of life at 12-month follow-up. Analyses were by intention to treat. FINDINGS: In the group assigned the levonorgestrel-releasing IUS, 24 (20%) women had had hysterectomy and 81 (68%) continued to use the system at 12 months. Of the women assigned to the hysterectomy group, 107 underwent the operation. Health-related quality of life improved significantly in both the IUS and hysterectomy groups (change 0.10 [95% CI 0.06-0.14] in both groups) as did other indices of psychological wellbeing. There were no significant differences between the treatment groups except that women with hysterectomy suffered less pain. Overall costs were about three times higher for the hysterectomy group than for the IUS group. INTERPRETATION: The significant improvement in health-related quality of life highlights the importance of treating menorrhagia. During the first year the levonorgestrel-releasing IUS was a cost-effective alternative to hysterectomy in treatment of this disorder.

Adult↗

A double-blind trial of ethamsylate in the treatment of primary and intrauterine-device menorrhagia.

22 patients complaining of primary menorrhagia or menorrhagia associated with an intrauterine device (I.U.C.D.) were studied in a double blind trial with crossover of ethamsylate and placebo. Acutal menstrual blood-losses were calculated from the iron content of used sanitary material during one pre-trail menstrual period and four trial menstrual periods, during which patients received ethamsylate ("Dicynene") treatment during two menstrual cycles and placebo during two cycles. During ethamsylate treatment the mean menstrual blood-loss was reduced by 50% in patients with primary menorrhagia and by 19% in patients with an I.U.C.D. This difference between the two groups is probably accounted for by the differing values of initial blood-loss which was significantly higher in the group with primary menorrhagia. Tampon usage and the duration of bleeding were not significantly altered by ethamsylate treatment. Reported side-effects, which were not serious, were equally common during ethamsylate and placebo treatment.

Adolescent↗

Medical Research Council randomised trial of endometrial resection versus hysterectomy in management of menorrhagia.

BACKGROUND: The most frequent indication for hysterectomy is menorrhagia, even though the uterus is normal in a large number of patients. Transcervical resection of the endometrium (TCRE) is a less drastic alternative, but success rates have varied and menorrhagia can recur. We have tested the hypothesis that the difference in the proportion of women dissatisfied and requiring further surgery within 3 years of TCRE or hysterectomy would be no more than 15%. METHODS: 202 women with symptomatic menorrhagia were recruited to a multicentre, randomised, controlled trial to compare the two interventions. TCRE and hysterectomy were randomly assigned in a ratio of two to one. The primary endpoints were women's satisfaction and need for further surgery. The patients' psychological and social states were monitored before surgery, then annually with a questionnaire. Analysis was by intention to treat. FINDINGS: Data were available for 172 women (56 hysterectomy, 116 TCRE); 26 withdrew before surgery and four were lost to follow-up. Satisfaction scores were higher for hysterectomy than for TCRE throughout follow-up (median 2 years), but the differences were not significant (at 3 years 27 [96%] of 28 in hysterectomy group vs 46 [85%] of 54 in TCRE group were satisfied; p = 0.16). 25 (22%) women in the TCRE group and five (9%) in the hysterectomy group required further surgery (relative risk 0.46 [95% CI 0.2-1.1], p = 0.053). TCRE had the benefits of shorter operating time, fewer complications, and faster rates of recovery. INTERPRETATION: TCRE is an acceptable alternative to hysterectomy in the treatment of menorrhagia for many women with no other serious disorders.

Adult↗

Menorrhagia in general practice--disease or illness.

Menorrhagia is a common presentation in primary care. The gynaecological literature defines menorrhagia, as the loss of 80 ml or more of blood per period and guidelines for treatment are based on this definition. There is extensive evidence that the majority of women who complain of heavy bleeding do not fit the medical definition. We interviewed women presenting with menorrhagia to explore their perceptions and their initial interaction with the medical profession. A distinct illness model emerged. Women had a precise understanding of their complaint, so that a change in her cycle was indicative of a problem to many women, without reference to outside criteria. Women attached particular importance to how they felt and to their ability to function and they rejected the medical emphasis on blood loss evaluation. Many women were dissatisfied with the consultation and experienced doctors as being dismissive of their problem. They were seeking an explanation for why their periods had changed and had concerns that related to their understanding of menstrual bleeding. Interviewees were unsure whether period problems could be described as illness, and what range of disturbance was normal. It is suggested that the disease model of menorrhagia is not relevant to the majority of women with this complaint. It is proposed that the disease model be replaced with illness models.

Adult↗

Severe menorrhagia due to factor VII deficiency successfully treated by thermal balloon endometrial ablation.

Factor VII deficiency, a rare inherited bleeding disorder, is often complicated by menorrhagia leading to severe anemia. These women are treated by repeated blood product transfusions, various hormone preparations, and repeated endometrial curettage. Despite the high risks involved, women with refractory disease were usually advised to undergo hysterectomy. A 36-year-old patient was known to suffer from factor VII deficiency and common variable immune deficiency, and had a long history of worsening menorrhagia. As various medical therapies failed to improve her menorrhagia, and she often required curettage and blood transfusions, we offered her more definitive treatment with thermal balloon endometrial ablation. The procedure was uneventful, and during 24 months of follow-up the patient has had several events of spotting but no heavy periods. It is suggested that thermal balloon endometrial ablation is a suitable minimally invasive therapeutic option for menorrhagia in women with factor VII deficiency.

Adult↗

Five-year follow-up of patients participating in a randomized trial of uterine balloon therapy versus rollerball ablation for treatment of menorrhagia.

STUDY OBJECTIVE: To collect long-term follow-up information from women who participated in a randomized trial comparing uterine balloon therapy (UBT; Gynecare, Somerville, NJ) with rollerball ablation for treatment of menorrhagia. DESIGN: Five-year contact of participants treated in a 1996 multicenter, randomized trial (Canadian Task Force classification I). SETTING: Twelve North American university and private practice centers. PATIENTS: Women treated with endometrial ablation for menorrhagia who were available for 5-year follow-up. INTERVENTION: Uterine balloon therapy or rollerball ablation. MEASUREMENTS AND MAIN RESULTS: Of 255 women treated under the original protocol, 147 were available to be interviewed 5 years after the procedure. Of these, 25 patients reported hysterectomy, repeat ablation, or dilatation and curettage (D&C) between years 3 and 5, leaving 122 eligible for analysis (61 UBT, 61 rollerball). Of these 122 patients, 58 (95%) having UBT and 59 (97%) having rollerball ablation reported normal or less bleeding. Similarly, 93% and 100%, respectively, were satisfied with the procedure. Among the total population of 255 women, 42 hysterectomies (21 UBT, 21 rollerball), 5 repeat ablations (3 UBT, 2 rollerball), and 1 D&C (rollerball) were reported by year 5. Thirty-five hysterectomies (83%) were performed because of bleeding and/or pelvic pain; one-third of them were associated with myomas. Nearly 7 of 10 women were cured of menorrhagia without additional intervention 5 years after ablation. CONCLUSION: UBT continues to be an effective, simple treatment of menorrhagia, with clinical outcomes similar to those of rollerball ablation at 5-year follow-up.

Adult↗

Endometrial ablation with a thermal balloon for the treatment of menorrhagia.

STUDY OBJECTIVE: To evaluate the safety and clinical efficacy of a uterine thermal balloon endometrial ablation system for the treatment of menorrhagia. DESIGN: Prospective pilot study. SETTING: University-affiliated teaching hospital. PATIENTS: Thirty women with menorrhagia who met inclusion and exclusion criteria and signed informed consent. INTERVENTIONS: Under general (9 women) or neuroleptic (21) anesthesia and paracervical block, a 16-cm long, 3-mm diameter catheter with a latex balloon at its tip, housing a heating element, was inserted blindly transcervically into the uterus and filled with sterile 5% dextrose in water solution (range 2-21 ml, mean 9.2 ml). The catheter was connected to a control unit that maintained the temperature at 87 degrees C, monitored the pressure, and terminated the treatment after 8 minutes. MEASUREMENTS AND MAIN RESULTS: There were no intraoperative or postoperative complications. At 6 months 25 patients (83%) reported significant improvement in menorrhagia (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 7). By 12 months 23 women (77%) reported significant improvement (amenorrhea 1, staining 4, hypomenorrhea 13, moderate improvement 5). CONCLUSIONS: Uterine balloon thermal therapy is a safe and effective option for women with menorrhagia. The procedure does not require additional training and expertise in operative hysteroscopy and the presently used energy sources. It requires no cervical dilatation (5 mm), is tolerated well under neuroleptic anesthesia, and potentially can be offered as an office procedure under local anesthesia.

Adult↗

Thermal balloon endometrial ablation to treat menorrhagia in high-risk surgical candidates.

OBJECTIVE: To evaluate the safety and efficacy of thermal balloon therapy in a subset of women with menorrhagia considered to be high-risk surgical candidates for hysteroscopic endometrial ablation or hysterectomy. DESIGN: Prospective, observational study (Canadian Task Force classification II-2). SETTING: University-affiliated teaching hospital. PATIENTS: Women with menorrhagia, at high risk because of bleeding disorders (12), morbid obesity (6), heart-lung transplantation (2), cardiac pacemaker (2), postmenopausal bleeding (8), bowel disease with extensive adhesions and ileostomies (3), cervical stenosis (3), and other medical disorders (9). INTERVENTION: Treatment consisted of controlled heating to 87 degrees C of 5% dextrose in water within an intrauterine latex balloon pressurized to 170 mm Hg for 8 minutes. General anesthesia was used in 28 patients (60%) and local anesthesia with or without intravenous sedation in 18 (40%). MEASUREMENTS AND MAIN RESULTS: No intraoperative complication occurred and postoperative morbidity was minimal. Follow-up of 43 women ranged between 6 and 30 months. Overall success of the procedure was 79% (34 patients), with 33% reporting amenorrhea, 19% hypomenorrhea, 28% eumenorrhea, and 21% menorrhagia. CONCLUSION: Thermal balloon endometrial ablation is safe and effective in treating menorrhagia when other therapies are contraindicated or difficult to perform.

Adult↗

Menorrhagia: an update.

Menorrhagia is defined as a 'complaint of heavy cyclical menstrual bleeding occurring over several consecutive cycles'. Objectively it is a total menstrual blood loss equal to or greater than 80 ml per menstruation. It is estimated that approximately 30% of women complain of menorrhagia. Excessive bleeding is the main presenting complaint in women referred to gynecologists and it accounts for two-thirds of all hysterectomies, and most of endoscopic endometrial destructive surgery. Thus, menorrhagia is an important healthcare problem. Its etiology, investigation, medical and surgical management are described. In approximately 50% of cases of menorrhagia no pathology is found at hysterectomy. Abnormal levels of prostaglandins or the fibrinolytic system in the endometrium have been implicated. Effective medical treatments suitable for long-term use include intrauterine progestogens, antifibrinolytic agents (tranexamic acid) and nonsteroidal anti-inflammatory agents (mefenamic acid). Over the past decade there has been increasing use of endometrial destructive techniques as an alternative to hysterectomy. Their further refinement and the advent of fibroid embolization has increased the options available to women.

Anti-Inflammatory Agents, Non-Steroidal↗

Effectiveness and mechanism of action of desmopressin in the treatment of copper intrauterine device-related menorrhagia: a pilot study.

BACKGROUND: Desmopressin, a synthetic analogue of the natural hormone vasopressin, stimulates endogenous haemostasis and exerts a powerful myometrial and vasoconstrictor action in a variety of pharmacological preparations. Both mechanisms of action may have therapeutic value for the treatment of intrauterine device (IUD)-related menorrhagia, which is believed to be caused not only by altered local haemostasis but also-according to a new hypothesis-by decreased vascular uterine resistance. The aim of this prospective study was to evaluate the effect of vasopressin drug on menstrual blood loss and on changes, if any, in uterine flow impedance. Mefenamic acid, which is commonly used to treat IUD-related menorrhagia, was administered as a comparison. METHODS: Twenty-four women with IUD-induced menorrhagia were recruited and randomly allocated to treatment with either desmopressin or mefenamic acid. Menstrual blood loss (measured by pictorial blood loss assessment chart) and uterine artery resistance (measured with transvaginal colour Doppler) performed in two pretreatment periods were compared with 3-month treatment periods. RESULTS: Menstrual blood loss was significantly reduced in both treatment groups. In the desmopressin group, the effect was clinically useful in all subjects, but in the mefenamic group menstrual blood loss was consistently menorrhagic in two patients. No significant differences were observed in the uterine artery pulsatility index before and during treatment. CONCLUSIONS: Desmopressin may be a useful therapeutic tool for many women with IUD-related menorrhagia. Its mechanism of action lies in an ability to enhance local haemostasis, without affecting uterine blood flow.

Adult↗

Reduced levels of VEGF-A and MMP-2 and MMP-9 activity and increased TNF-alpha in menstrual endometrium and effluent in women with menorrhagia.

BACKGROUND: Heavy regular menstrual periods (menorrhagia) are an important cause of ill health in women and remain the leading indication for hysterectomy. Abnormalities of the endometrial blood vessels are among the possible causes of this condition. Many different factors affect endothelial cell growth, function and vessel remodelling. We sought to determine whether the levels of vascular endothelial growth factor-A (VEGF-A), tumour necrosis factor-alpha (TNF-alpha), matrix metalloproteinase (MMP)-2 and MMP-9 and soluble VEGF receptor-1 (VEGF-R1) were altered in the menstrual effluent of women with objective menorrhagia. We have also quantitated the VEGF-A mRNA in the menstruated endometrium. METHODS AND RESULTS: We recruited 37 women and determined their menstrual blood loss (MBL) over two cycles and collected menstrual effluent during the 2nd day of bleeding for 4 h. There was no difference in the total level of VEGF-A, and neither latent MMP. However, the concentration of VEGF-A was significantly reduced in the women with menorrhagia, as was the VEGF-A mRNA level. In addition, the active forms of both MMPs were markedly reduced and the total sVEGF-R1 as well as the TNF-alpha content were increased. CONCLUSIONS: This is the first study to show abnormalities of factors important for endothelial cell behaviour in the endometrium of women with menorrhagia. This may underlie the disordered vessel structure and/or function in this condition.

Adult↗

Vascular smooth muscle alpha-actin distribution around endometrial arterioles during the menstrual cycle: increased expression during the perimenopause and lack of correlation with menorrhagia.

Menorrhagia affects approximately 9% of all women, increasing to 20% during the perimenopause. The majority of menstrual loss occurs through the spiral arterioles - specialized endometrial vessels that are intimately involved in controlling menstruation. Our aim was to compare the distribution of vascular smooth muscle alpha-actin using immunohistochemical techniques in the endometrium of women before and during the perimenopause and with or without menorrhagia. We hypothesized that differences in vessel numbers and types exhibiting alpha-actin staining would exist between these groups, reflecting structural/functional differences. The results showed that perimenopausal menorrhagic women had significantly more smooth muscle alpha-actin expression than non-perimenopausal controls in four out of five menstrual cycle stages (P < 0.05), while perimenopausal non-menorrhagic women demonstrated a significant increase at the mid-proliferative stage only (P < 0.007). No significant differences occurred between women with or without menorrhagia before or during the perimenopause. Perimenopausal women had significantly more straight arterioles (P < 0.02) than women prior to perimenopause at the late secretory stage, while non-perimenopausal women demonstrated significantly higher numbers of spiral arterioles (P < 0.002) in the early secretory stage, although this difference had disappeared by the late secretory stage. In conclusion, we found no major differences in endometrial vascular smooth muscle alpha-actin staining between women with and without menorrhagia, but significant increases in alpha-actin staining in women showing perimenopausal symptoms.

Actins↗

Management of cyclical menorrhagia with prostaglandin synthetase inhibitor.

A well controlled double blind prospective trial was undertaken to determine the efficacy of mefenamic acid in the treatment of menorrhagia. Eighty patients who had unexplained cyclical menorrhagia with secretory endometrium received mefenamic acid orally in a dose of 500 mg 8 hourly or a placebo tablet thrice daily starting from day-one of the cycle for 5 days or till cessation of menses. Mefenamic acid administration caused a statistically significant reduction in the number of days of bleeding from 9.7 +/- 3.1 days before treatment to 4.1 +/- 0.6 days after treatment. It also brought about significant reduction in the amount of bleeding in terms of number of pads used per day, that is from 15.2 +/- 3.1 before treatment to 6.5 +/- 0.02 after treatment. Eighty-six percent patients in the treatment group had control of menorrhagia with the drug compared to 20% in the control group without drugs and this difference was statistically significant. Mefenamic acid proved to be a potent and efficacious agent in the control of unexplained menorrhagia.

Adult↗