female

Practical Recommendations for Minimizing Pain and Anxiety with IUD Insertion

Author/s: 
Viktoriya Ovsepyan, Petra Kelsey, Ann E Evensen

Background: Intrauterine devices (IUDs) are one of the most effective, long-lasting, and convenient contraceptive methods available in the United States. Unfortunately, the anticipated pain and anxiety associated with an IUD insertion procedure deter many people from using this contraceptive method.

Methods: A literature review was conducted on PubMed by searching the terms “IUD insertion”, “pain management”, “anxiety”, “gynecologic procedures”. The Cochrane database was also searched for reviews about pain management methods during IUD insertions. Findings were summarized using the American Academy of Family Physicians’ Strength of Recommendation Taxonomy (SORT) scale.

Results: Pharmacologic methods that can be used to reduce pain with IUD insertion include naproxen, tramadol, lidocaine paracervical blocks, 10% lidocaine spray, lidocaine-prilocaine cream, and EMLA cream. Non-pharmacologic methods for reducing pain or anxiety during gynecologic procedures include pre-insertion counseling, “verbal analgesia”, lavender aromatherapy, distraction with music or television, using Valsalva maneuver instead of tenaculum during IUD insertion, and use of heating pad during procedure.

Conclusion: Moderately effective pharmacologic and non-pharmacologic methods exist for reducing pain and anxiety with IUD insertion. These treatment methods should be offered to create a more comfortable experience for patients. Additional research is needed to determine the comparative efficacy of these methods.

Active Monitoring With or Without Endocrine Therapy for Low-Risk Ductal Carcinoma In Situ: The COMET Randomized Clinical Trial

Author/s: 
E. Shelley Hwang, Terry Hyslop, Thomas Lynch, et al.

Importance Active monitoring for low-risk ductal carcinoma in situ (DCIS) of the breast has been proposed as an alternative to guideline-concordant care, but the safety of this approach is unknown.

Objective To compare rates of invasive cancer in patients with low-risk DCIS receiving active monitoring vs guideline-concordant care.

Design, Setting, and Participants Prospective, randomized noninferiority trial enrolling 995 women aged 40 years or older with a new diagnosis of hormone receptor–positive grade 1 or grade 2 DCIS without invasive cancer at 100 US Alliance Cancer Cooperative Group clinical trial sites from 2017 to 2023.

Interventions Participants were randomized to receive active monitoring (follow-up every 6 months with breast imaging and physical examination; n = 484) or guideline-concordant care (surgery with or without radiation therapy; n = 473).

Main Outcomes and Measures The primary outcome was 2-year cumulative risk of ipsilateral invasive cancer diagnosis, according to planned intention-to-treat and per-protocol analyses, with a noninferiority bound of 5%.

Results The median age of the 957 participants analyzed was 63.6 (95% CI, 55.5-70.5) years in the guideline-concordant care group and 63.7 (95% CI, 60.0-71.6) years in the active monitoring group. Overall, 15.7% of participants were Black and 75.0% were White. In this prespecified primary analysis, median follow-up was 36.9 months; 346 patients had surgery for DCIS, 264 in the guideline-concordant care group and 82 in the active monitoring group. Forty-six women were diagnosed with invasive cancer, 19 in the active monitoring group and 27 in the guideline-concordant care group. The 2-year Kaplan-Meier cumulative rate of ipsilateral invasive cancer was 4.2% in the active monitoring group vs 5.9% in the guideline-concordant care group, a difference of −1.7% (upper limit of the 95% CI, 0.95%), indicating that active monitoring is not inferior to guideline-concordant care. Invasive tumor characteristics did not differ significantly between groups.

Conclusions and Relevance Women with low-risk DCIS randomized to active monitoring did not have a higher rate of invasive cancer in the same breast at 2 years compared with those randomized to guideline-concordant care.

Trial Registration ClinicalTrials.gov Identifier: NCT02926911

Male-Partner Treatment to Prevent Recurrence of Bacterial Vaginosis

Author/s: 
Lenka A Vodstrcil, Erica L Plummer, Christopher K Fairley, Jane S Hocking, Matthew G Law, Kathy Petoumenos, Deborah Bateson, Gerald L Murray, Basil Donovan, Eric P F Chow, Marcus Y Chen, John Kaldor, Catriona S Bradshaw, StepUp Team

Background
Bacterial vaginosis affects one third of reproductive-aged women, and recurrence is common. Evidence of sexual exchange of bacterial vaginosis–associated organisms between partners suggests that male-partner treatment may increase the likelihood of cure.

Methods
This open-label, randomized, controlled trial involved couples in which a woman had bacterial vaginosis and was in a monogamous relationship with a male partner. In the partner-treatment group, the woman received first-line recommended antimicrobial agents and the male partner received oral and topical antimicrobial treatment (metronidazole 400-mg tablets and 2% clindamycin cream applied to penile skin, both twice daily for 7 days). In the control group, the woman received first-line treatment and the male partner received no treatment (standard care). The primary outcome was recurrence of bacterial vaginosis within 12 weeks.

Results
A total of 81 couples were assigned to the partner-treatment group, and 83 couples were assigned to the control group. The trial was stopped by the data and safety monitoring board after 150 couples had completed the 12-week follow-up period because treatment of the woman only was inferior to treatment of both the woman and her male partner. In the modified intention-to-treat population, recurrence occurred in 24 of 69 women (35%) in the partner-treatment group (recurrence rate, 1.6 per person-year; 95% confidence interval [CI], 1.1 to 2.4) and in 43 of 68 women (63%) in the control group (recurrence rate, 4.2 per person-year; 95% CI, 3.2 to 5.7), which corresponded to an absolute risk difference of −2.6 recurrences per person-year (95% CI, −4.0 to −1.2; P<0.001). Adverse events in treated men included nausea, headache, and metallic taste.

Conclusions
The addition of combined oral and topical antimicrobial therapy for male partners to treatment of women for bacterial vaginosis resulted in a lower rate of recurrence of bacterial vaginosis within 12 weeks than standard care. (Funded by the National Health and Medical Research Council of Australia; StepUp Australian New Zealand Clinical Trials Registry number, ACTRN12619000196145.)

Treatment of Vasomotor Symptoms

Author/s: 
Karina Atwell, Morgan White, Greta Kuphal, Makeba Williams, Sarina Schrager

Vasomotor symptoms (VMS) related to the menopausal transition affect the majority of women and contribute to significant quality of life burden. Incidence, length, severity and report of symptoms vary by race, ethnicity, and coexisting health conditions. The pathophysiology of VMS is not fully understood and is likely multifactorial, involving changes in the hypothalamicpituitary-ovarian axis during the menopausal transition. Treatment approaches include lifestyle modifications, hormonal and non-hormonal therapies, including integrative and complementary medicine approaches. Systemic hormone therapy with estrogen is the most effective treatment. Emerging evidence suggests that treatment with SSRIs, SNRIs, and gabapentin is effective for many women who want to avoid hormone therapy. A shared decision approach to treatment decisions involves consideration of risks with treatment options and discussion of patient priorities.

Screening for Osteoporosis to Prevent Fractures: US Preventive Services Task Force Recommendation Statement

Author/s: 
US Preventive Services Task Force

Importance Osteoporotic fractures are associated with psychological distress, subsequent fractures, loss of independence, reduced ability to perform activities of daily living, and death.

Objective The US Preventive Services Task Force (USPSTF) commissioned a systematic review to evaluate the evidence on the benefits and harms of screening for osteoporosis to prevent fractures in adults 40 years or older with no known diagnosis of osteoporosis or history of fragility fracture.

Population Adults 40 years or older without known osteoporosis or history of fragility fractures.

Evidence Assessment The USPSTF concludes with moderate certainty that screening for osteoporosis to prevent osteoporotic fractures in women 65 years or older has moderate net benefit. The USPSTF concludes with moderate certainty that screening for osteoporosis to prevent osteoporotic fractures in postmenopausal women younger than 65 years at increased risk has moderate net benefit. The USPSTF concludes that the evidence is insufficient and the balance of benefits and harms for screening for osteoporosis to prevent osteoporotic fractures in men cannot be determined.

Recommendation The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in women 65 years or older. (B recommendation) The USPSTF recommends screening for osteoporosis to prevent osteoporotic fractures in postmenopausal women younger than 65 years who are at increased risk for an osteoporotic fracture as estimated by clinical risk assessment. (B recommendation) The USPSTF concludes that the current evidence is insufficient to assess the balance of benefits and harms of screening for osteoporosis to prevent osteoporotic fractures in men. (I statement)

Sexual Dysfunction in Women

Author/s: 
Susan R Davis

The Clinical Problem
Because there is no universal definition of normal sexual function, what constitutes sexual difficulty is determined by a person’s subjective definition of unsatisfactory sexual well-being. The condition is usually described as unsatisfactory interest, arousal, orgasm, or other aspects of sexuality (e.g., sexual self-image), and the symptoms often coexist. The term “sexual dysfunction” is used when at least one of the symptoms is of substantial concern to the affected person. Sexual dysfunction negatively affects mental health, vitality, and social functioning and has an overall effect on quality of life that is of similar magnitude to that associated with chronic back pain or diabetes.

Genitourinary Syndrome of Menopause: A Systematic Review

Objectives. To conduct a systematic review of evidence regarding genitourinary syndrome of menopause (GSM) screening, treatment, and surveillance.

Data sources. Ovid/Medline®, Embase®, and EBSCOhost/CINAHL® from database inception through December 11, 2023.

Review methods. We employed methods consistent with the Agency for Healthcare Research and Quality Evidence-based Practice Center Program Methods Guidance to identify studies and synthesize findings for Key Questions related to screening for GSM, effectiveness and harms of U.S.-available interventions for GSM, appropriate followup intervals for patients using GSM treatments, and endometrial surveillance for patients using hormonal GSM treatments. For vaginal estrogen and vaginal or systemic non-estrogen hormonal interventions, energy-based interventions, and vaginal moisturizers, we first assessed study quality and then, for moderate or high-quality studies, reviewed outcomes related to GSM symptoms, treatment satisfaction, and adverse effects. For low-quality studies, we described limited study characteristics only. For studies of other non-hormonal interventions, we created an evidence map describing study characteristics without assessing study quality.

Results. After assessing 107 publications for risk of bias (RoB), we extracted and synthesized effectiveness and/or harms outcomes from 68 publications describing trials or prospective, controlled observational studies that were rated low, some concerns, or moderate RoB (24 estrogen publications, 35 non-estrogen, 11 energy-based, and 4 moisturizers). Of 39 high, serious, or critical RoB publications, we extracted long-term harms from only 15 uncontrolled studies of energy-based interventions (all serious or critical RoB due to confounding). An additional 66 publications evaluating 46 non-hormonal interventions, including natural products, mind/body practices, and educational interventions, were described in an evidence map. Across all 172 publications, studies differed in GSM definitions, diagnosis, enrollment criteria, and outcomes assessed. Few studies enrolled women with a history of breast or gynecologic cancers. Overall, we found that vaginal estrogen, vaginal dehydroepiandrosterone (DHEA), vaginal moisturizers, and oral ospemifene may all improve at least some GSM symptoms, while evidence does not demonstrate the efficacy of energy-based therapies, vaginal or systemic testosterone, vaginal oxytocin, or oral raloxifene or bazedoxifene for any GSM symptoms. Harms reporting was limited, in part, by studies not being sufficiently powered to evaluate infrequent but serious harms, though most studies did not report frequent serious harms. Common non-serious adverse effects varied by treatment and dose. No studies evaluated GSM screening or directly addressed appropriate followup intervals or the effectiveness and harms of endometrial surveillance among women with a uterus receiving hormonal therapy for GSM. The longest followup period for active endometrial surveillance in an included trial was 12 weeks (vaginal estrogen) or 1 year (non-estrogen hormonal interventions).

Conclusions. This systematic review provides comprehensive, up-to-date information to guide patients, clinicians, and policymakers regarding GSM. Despite the breadth of included studies, findings were limited by several factors, including heterogeneity in intervention-comparator-outcome combinations. Future studies would be strengthened by a standard definition and uniform diagnostic criteria for GSM, a common set of validated outcome measures and reporting standards, and attention to clinically relevant populations and intervention comparisons. Lack of long-term data assessing efficacy, tolerability, and safety of GSM treatments leaves postmenopausal women and clinicians without evidence to guide treatment longer than 1 year.

Bacterial vaginosis

Author/s: 
Michal Braunstein, Amanda Selk

Bacterial vaginosis is the most common cause of abnormal vaginal discharge, affecting 23%–30% of reproductive-aged people
Bacterial vaginosis is caused by a disrupted vaginal microbiome balance. Symptoms include itch, dysuria, and a thin, grey discharge with a “fishy” odour, particularly after coitus. Risk factors include smoking and unprotected intercourse, including oral sex.

Subscribe to female