Characterizing Adverse Events Reporting for an Over-the-Counter Disposable Intravaginal Support Device for Stress Urinary Incontinence.

OBJECTIVES: In recent years, new intravaginal support devices for stress urinary incontinence have been introduced to the market. Although studies have demonstrated their safety and efficacy, few studies have examined adverse events attributed to their use. The objective of this study was to characterize reported adverse events for an over-the-counter intravaginal support device and determine whether further medical treatment was necessary to manage the adverse event. METHODS: We searched the Manufacturer and User Device Experience database from January 2015 to September 2020 for pertinent reported adverse events, which included the unique report key, event date, report date, event text descriptions, and resulting course of treatment. Per Manufacturer and User Device Experience database mandatory requirements, all reports were submitted by the manufacturer within 30 days of receiving the consumer's voluntary submission. RESULTS: A total of 257 reports were included for analysis. The most common reported adverse event was related to the string of the device, which broke with either removal or insertion of the device (230 of 257 [89.5%]). The majority of patients who required medical attention (133 of 257 [51.8%]) were evaluated and managed in the office setting (85 of 133 [63.9%]), whereas 37% (95 of 257) of patients were able to self-treat. CONCLUSIONS: Most complications attributed to device use were self-managed or managed in the outpatient setting. No emergent hospitalizations or deaths were attributed to their use, supporting their generally low-risk profile and high tolerability. Limitations of this review include the inability to decipher a denominator for these reported adverse events and the potential bias attributed to voluntary consumer reporting.

Is Nocturia Associated With Detrusor Underactivity?

OBJECTIVES: Detrusor underactivity (DU) is diagnosed using urodynamic testing. We hypothesized that nocturia is associated with detrusor underactivity. METHODS: We performed a retrospective chart review of all women who underwent urodynamic testing at our institution between 2016 and 2018. Uroflowmetry and pressure-flow study parameters were compared between women with nocturia (≥2 voids/night) and without nocturia (0-1 void/night). Detrusor underactivity was diagnosed using 3 different criteria: (1) bladder voiding efficiency (BVE) of <90%, (2) bladder contractility index of <100, and (3) a composite of three urodynamic measures (Gammie criteria). RESULTS: Of 358 women, 172 (48%) were in the nocturia group and 186 (52%) were in the no nocturia group. On uroflowmetry, median postvoid residual volume was similar (20 mL) in both groups. Median maximum flow rate (15 vs 17 mL/s, P < 0.05) and average flow rate (6 mL/s vs 7 mL/s, P < 0.05) were significantly lower in the nocturia group compared with the no nocturia group. During pressure-flow study, a significantly greater proportion of women with nocturia were unable to void around the catheter (30% vs 27%, P < 0.01). The overall rate of DU varied with the criteria used: BVE (54%), bladder contractility index (41%), and Gammie criteria (7%). The rate of DU using the BVE criteria was significantly higher in the nocturia group (63% vs 48%, P < 0.01), but no significant differences were noted using the other criteria. CONCLUSIONS: Nocturia is associated with reduced voiding efficiency in women. The diagnosis of DU using urodynamics is challenging.

Detection of COVID-19 in a Vulvar Lesion.

As new information about coronavirus disease 2019 (COVID-19) is rapidly discovered, clinicians are better equipped to make informed decisions for their patients. While current research suggests COVID-19 viral antigen is not found in vaginal secretions, its detectability in the female lower genital tract may have clinical implications for obstetric and gynecologic care for women. We present a case of a woman at 31 weeks' gestation with simultaneous upper respiratory symptoms and vulvovaginitis. She was found to have a vulvar lesion positive for severe acute respiratory syndrome-COVID by viral swab. This case shows that COVID-19 is detectable in the vulva. This may have implications for health care workers' exposure and personal protective equipment needs. While vertical transmission has largely not been reported, the presence of detectable virus in the female lower genital tract makes this a continued possibility and area of study. KEY POINTS: · COVID-19 is detectable in the female lower genital tract.. · The detection of COVID-19 in the vulva may have implications for personal protective equipment use.. · The detection of COVID-19 in vulvovaginal lesions makes vertical transmission a continued possibility..

Selective serotonin reuptake inhibitors for depression in pregnancy.

Perinatal depression is associated with a high risk of morbidity and mortality and may have long-term consequences on child development. The US Preventive Services Task Force has recently recognized the importance of identifying and treating women with depression in the perinatal period. However, screening and accessing appropriate treatment come with logistical challenges. In many areas, there may not be sufficient access to psychiatric care, and, until these resources develop, the burden may inadvertently fall on obstetricians. As a result, understanding the risks of perinatal depression in comparison with the risks of treatment is important. Many studies of selective serotonin reuptake inhibitors in pregnancy fail to control for underlying depressive illness, which can lead to misinterpretation of selective serotonin reuptake inhibitor risk by clinicians. This review discusses the risks and benefits of selective serotonin reuptake inhibitor treatment in pregnancy within the context of perinatal depression. Whereas selective serotonin reuptake inhibitors may be associated with certain risks, the absolute risks are low and may be outweighed by the risks of untreated depression for many women and their offspring.