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Background: The levonorgestrel intrauterine system and combined oral contraceptives are the 2 most commonly used nonsurgical treatments for heavy menstrual bleeding in the United States. However, there are limited data on their relative effectiveness and on their impact on bleeding-specific quality of life., Objective: This study aimed to compare the effectiveness of the 52-mg levonorgestrel intrauterine system with that of combined oral contraceptives for improving quality of life among individuals who self-report heavy menstrual bleeding. We hypothesized that the levonorgestrel intrauterine system would be more effective than combined oral contraceptives at 6 and 12 months after treatment., Study Design: We conducted a pragmatic randomized trial of individuals who self-reported heavy menstrual bleeding. Individuals were eligible if they did not have contraindications to either the levonorgestrel intrauterine system or combined oral contraceptives and were determined to have a nonstructural cause of heavy menstrual bleeding. Eligible and consenting participants were randomly assigned in a 1:1 ratio to receive a 52-mg levonorgestrel intrauterine system or a monophasic 30- or 35-μg ethinyl estradiol-containing combined oral contraceptive. The main outcome was mean change in bleeding-related quality of life, measured by the 20-question Menstrual Bleeding Questionnaire (score range, 0-75) at 6 and 12 months. Differences in group means and confidence intervals for the Menstrual Bleeding Questionnaire score were computed by multivariable linear mixed-effects regression; 24 participants per group were needed to detect a 10-point difference in change in mean Menstrual Bleeding Questionnaire score between individuals treated with the levonorgestrel intrauterine system and those treated with combined oral contraceptives at each follow-up time point., Results: A total of 62 individuals were randomly assigned to treatment (n=29 allocated to levonorgestrel intrauterine system and n=33 allocated to combined oral contraceptives) and included in the intention-to-treat analyses; 19 of 29 received the levonorgestrel intrauterine system and 31 of 33 received combined oral contraceptives. Eleven percent identified as Black or African American and 44% identified as Hispanic or Latina. Participant characteristics were similar among study groups. Bleeding-related quality of life increased in both study arms, as reflected by a significant decrease in Menstrual Bleeding Questionnaire scores beginning at 6-week follow-up. In the main intention-to-treat analyses (n=62), there were no differences in mean change in Menstrual Bleeding Questionnaire scores at 6 months (difference=-2.5; 95% confidence interval, -10.0 to +5.0) or 12 months (difference=-1.1; 95% confidence interval, -8.7 to +6.5). Findings were similar in the subsets of participants with any follow-up visits (n=52) and who completed all follow-up visits (n=42). In the per-protocol analyses (n=47), a significantly greater decrease in Menstrual Bleeding Questionnaire score was observed in the levonorgestrel intrauterine system arm at 6 months after treatment (difference=-7.0; 95% confidence interval, -13.8 to -0.2) but not at 12 months (difference=-4.8; 95% confidence interval, -11.8 to 2.3) compared with the combined oral contraceptive arm., Conclusion: No differences in change of bleeding-related quality of life were observed between the levonorgestrel intrauterine system and combined oral contraceptives at 6 or 12 months. Patients should be counseled that the levonorgestrel intrauterine system and combined oral contraceptives are both effective options for improving bleeding-related quality of life., (Copyright © 2023. Published by Elsevier Inc.)

Objective: To develop a core outcome set for heavy menstrual bleeding (HMB)., Design: Core outcome set (COS) development methodology described by the COMET initiative., Setting: University hospital gynaecology department, online international survey and web-based international consensus meetings., Population or Sample: An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents., Methods: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two-round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS., Main Outcome Measures: Outcome importance was assessed in the Delphi survey on a 9-point scale., Results: From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level., Conclusions: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy., (© 2023 The Authors. BJOG: An International Journal of Obstetrics and Gynaecology published by John Wiley & Sons Ltd.)

Menstruation is a personal and cultural experience with financial and health implications. Menstruation historically has been managed with disposable commodities, including tampons and pads. New technologies, including underwear and menstrual cups and discs, have emerged to address diverse menstrual needs such as prioritization of sustainability, discretion, and inclusivity. New technologies are not routinely integrated into history taking or validated questionnaires, which currently rely on traditional tampon and pad use for identifying individuals with heavy menstrual bleeding. Review of menstrual technologies and accessories provides insight to empower gynecologists and other clinicians to take comprehensive menstrual histories, including strategies for identification of heavy menstrual bleeding and troubleshooting menstrual disturbances, within the context of new menstrual technologies., Competing Interests: Financial Disclosure Alison Edelman reports honoraria and travel reimbursement from ACOG, WHO, and Gynuity for committee activities and honoraria for peer review from the Karolinska Institute. She receives royalties from Up to Date, Inc. Oregon Health & Science University receives research funding from OHSU Foundation, Merck, HRA Pharma, and NIH, where Dr. Edelman is the principal investigator. The other authors did not report any potential conflicts of interest., (Copyright © 2023 The Author(s). Published by Wolters Kluwer Health, Inc.)

Patient-reported outcome measures (PROMs) have the potential to be extremely valuable in the clinical care delivery for women who report heavy menstrual bleeding (HMB). Increasingly, studies on HMB have incorporated PROMs to evaluate the impact of bleeding on quality of life. These measures have included semiquantitative charts and pictograms, questionnaires to assess symptoms and impact on quality of life, and health-related quality of life questionnaires. Recent systematic reviews have highlighted inconsistency of outcome measurement across studies on HMB as a challenge limiting the interpretability of the body of literature and the ability to generate consensus on the relative effectiveness of treatment options. Consequently, research initiatives and international collaborations are working to harmonize outcome measurement. Harmonizing the use of questionnaires in research and clinical care has the potential to improve patient-centered care delivery for women with HMB and improve the generation of patient-focused evidence-based guidelines for the evaluation and treatment of HMB., (Copyright © 2016. Published by Elsevier Ltd.)

Objective: The objectives of the study were to compare among women who had an endometrial ablation the risks of treatment failure and subsequent gynecological procedures between women with regular and irregular heavy uterine bleeding and to determine other characteristics associated with the risk of treatment failure., Study Design: This study was a retrospective cohort of 968 women who underwent endometrial ablation between January 2007 and July 2009. Preoperative bleeding pattern was categorized as regular or irregular. Treatment failure was defined as reablation or hysterectomy. Subsequent gynecological procedures included endometrial biopsy, dilation and curettage, hysteroscopy, reablation, or hysterectomy. We calculated the odds of treatment failure and gynecological procedures using multiple logistic regression., Results: Bleeding pattern prior to ablation was heavy and regular in 30% (n = 293), heavy and irregular in 36% (n = 352), and unspecified in 30% (n = 286). We found no differences in treatment failure (13% vs 12%, P = .9) or subsequent procedures (16% vs 18%, P = .7) between women with regular and irregular bleeding. Compared with the women with regular bleeding, the women with irregular bleeding were not at increased odds of treatment failure or subsequent procedures (odds ratio [OR], 1.07; 95% confidence interval [CI], 0.65-1.74 and OR, 1.17; 95% CI, 0.76-1.80, respectively). Factors associated with an increased odds of treatment failure and subsequent procedures included tubal ligation (OR, 1.94; 95% CI, 1.30-2.91 and OR, 1.71; 95% CI, 1.20-2.43, respectively); dysmenorrhea (OR, 2.42; 95% CI, 1.44-4.06 and OR, 1.93; 95% CI, 1.20-3.13, respectively); and obesity (OR, 1.82; 95% CI, 1.21-2.73 and OR, 1.75; 95% CI, 1.22-2.50, respectively)., Conclusion: Preoperative bleeding pattern did not appear to affect failure rates or the need for gynecological procedures after endometrial ablation. Other risk factors for ablation failure identified included preoperative dysmenorrhea, prior tubal ligation, and obesity., (Copyright © 2014 Elsevier Inc. All rights reserved.)

Objective: To compare the effectiveness of nonsurgical abnormal uterine bleeding treatments for bleeding control, quality of life (QOL), pain, sexual health, patient satisfaction, additional treatments needed, and adverse events., Data Sources: MEDLINE, Cochrane databases, and Clinicaltrials.gov were searched from inception to May 2012. We included randomized controlled trials of nonsurgical treatments for abnormal uterine bleeding presumed secondary to endometrial dysfunction and abnormal uterine bleeding presumed secondary to ovulatory dysfunction. Interventions included the levonorgestrel intrauterine system, combined oral contraceptive pills (OCPs), progestins, nonsteroidal anti-inflammatory drugs (NSAIDs), and antifibrinolytics. Gonadotropin-releasing hormone agonists, danazol, and placebo were allowed as comparators., Methods of Study Selection: Two reviewers independently screened 5,848 citations and extracted eligible trials. Studies were assessed for quality and strength of evidence., Tabulation, Integration, and Results: Twenty-six articles met inclusion criteria. For reduction of menstrual bleeding in women with abnormal uterine bleeding presumed secondary to endometrial dysfunction, the levonorgestrel intrauterine system (71-95% reduction), combined OCPs (35-69% reduction), extended cycle oral progestins (87% reduction), tranexamic acid (26-54% reduction), and NSAIDs (10-52% reduction) were all effective treatments. The levonorgestrel intrauterine system, combined OCPs, and antifibrinolytics were all superior to luteal-phase progestins (20% increase in bleeding to 67% reduction). The levonorgestrel intrauterine system was superior to combined OCPs and NSAIDs. Antifibrinolytics were superior to NSAIDs for menstrual bleeding reduction. Data were limited on other important outcomes such as QOL for women with abnormal uterine bleeding presumed secondary to endometrial dysfunction and for all outcomes for women with abnormal uterine bleeding presumed secondary to ovulatory dysfunction., Conclusion: For the reduction in mean blood loss in women with heavy menstrual bleeding presumed secondary to abnormal uterine bleeding presumed secondary to endometrial dysfunction, we recommend the use of the levonorgestrel intrauterine system over OCPs, luteal-phase progestins, and NSAIDs. For other outcomes (QOL, pain, sexual health, patient satisfaction, additional treatments needed, and adverse events) and for treatment of abnormal uterine bleeding presumed secondary to ovulatory dysfunction, we were unable to make recommendations based on the limited available data.

Objectives of this article are: (1) to explore the effects on women's lives by heavy or irregular menstrual bleeding; and (2) to examine whether aspects of women's lives most affected by heavy or irregular menstrual bleeding were adequately addressed by questions that are frequently used in clinical encounters and available questionnaires. We conducted four focus group sessions with a total of 25 English-speaking women who had reported abnormal uterine bleeding. Discussions included open-ended questions that pertained to bleeding, aspects of life affected by bleeding, and questions frequently used in clinical settings about bleeding and quality of life. We identified five themes that reflected how women's lives were affected by heavy or irregular menstrual bleeding: irritation/inconvenience, bleeding-associated pain, self-consciousness about odor, social embarrassment, and ritual-like behavior. Although women responded that the frequently used questions about bleeding and quality of life were important, they felt that the questions failed to go into enough depth to adequately characterize their experiences. Based on the themes identified in our focus group sessions, clinicians and researchers may need to change the questions used to capture "patient experience" with abnormal uterine bleeding more accurately.

Objective: To develop a core outcome set for heavy menstrual bleeding (HMB). Design: Core outcome set (COS) development methodology described by the COMET initiative. Setting: University hospital gynaecology department, online international survey and web‐based international consensus meetings. Population or sample: An international collaboration of stakeholders (clinicians, patients, academics, guideline developers) from 20 countries and 6 continents. Methods: Phase 1: Systematic review of previously reported outcomes to identify potential core outcomes. Phase 2: Qualitative studies with patients to identify outcomes most important to them. Phase 3: Online two‐round Delphi survey to achieve consensus about which outcomes are most important. Phase 4: A consensus meeting to finalise the COS. Main outcome measures: Outcome importance was assessed in the Delphi survey on a 9‐point scale. Results: From the 'long list' of 114, 10 outcomes were included in the final COS: subjective blood loss; flooding; menstrual cycle metrics; severity of dysmenorrhoea; number of days with dysmenorrhoea; quality of life; adverse events; patient satisfaction; number of patients going on to have further treatment for HMB and haemoglobin level. Conclusions: The final COS includes variables that are feasible for use in clinical trials in all resource settings and apply to all known underlying causes of the symptom of HMB. These outcomes should be reported in all future trials of interventions, their systematic reviews, and clinical guidelines to underpin policy. [ABSTRACT FROM AUTHOR]

Abstract: Objectives: (1) To systematically collect and organize into clinical categories all outcomes reported in trials for abnormal uterine bleeding (AUB); (2) to rank the importance of outcomes for patient decision making; and (3) to improve future comparisons of effects in trials of AUB interventions. Study Design and Setting: Systematic review of English-language randomized controlled trials of AUB treatments in MEDLINE from 1950 to June 2008. All outcomes and definitions were extracted and organized into major outcome categories by an expert group. Each outcome was ranked “critically important,” “important,” or “not important” for informing patients'' choices. Results: One hundred thirteen articles from 79 trials met the criteria. One hundred fourteen different outcomes were identified, only 15 (13%) of which were ranked as critically important and 29 (25%) as important. Outcomes were grouped into eight categories: (1) bleeding; (2) quality of life; (3) pain; (4) sexual health; (5) patient satisfaction; (6) bulk-related complaints; (7) need for subsequent surgical treatment; and (8) adverse events. Conclusion: To improve the quality, consistency, and utility of future AUB trials, we recommend assessing a limited number of clinical outcomes for bleeding, disease-specific quality of life, pain, sexual health, and bulk-related symptoms both before and after treatment and reporting satisfaction and adverse events. Further development of validated patient-based outcome measures and the standardization of outcome reporting are needed. [Copyright &y& Elsevier]