2 Minute Medicine Rewind January 25, 2021

An exploratory analysis of tamsulosin for Overactive Bladder (OAB) in men with varying voiding symptom burden

1. Among men with symptoms of overactive bladder with or without concomitant benign prostatic hyperplasia, tamsulosin therapy significantly reduced the symptoms of overactive bladder.

Evidence Rating Level: 2 (Good)

Lower urinary tract symptoms (LUTS) are common among older male adults and are most commonly attributed to either benign prostatic hyperplasic (BPH) or overactive bladder (OAB). Though there is significant overlap between the two pathologies in terms of signs and symptoms, it is recommended that men presenting with OAB only are managed with antimuscarinic medications or β-3 agonists; α-blockers like tamsulosin are notably absent from treatment guidelines. This study is a planned, secondary analysis of the Male Overactive Bladder Trial in Veterans (MOTIVE) trial, examining the effect of 0.4 mg of tamsulosin therapy nightly for four weeks on the symptoms of OAB among male veterans who may or may not have concomitant BPH. 116 participants were included in the analysis (mean [SD] age = 64.6 [10.4] years, 57.1% white). It was found that four weeks of tamsulosin therapy significantly reduced multiple OAB outcome measures, including a reduction in 24-hour urinary frequency from 11.3 to 9.9 (p < 0.0001); a decrease in mean maximum urgency rating from 2.5 to 2.2 points (p < 0.0001); and a decrease in mean nocturia from 2.1 to 1.8 nightly episodes (p < 0.001). Furthermore, the mean total AUA-7 SI score – a standardized questionnaire tracking storage symptoms (urgency, frequency, and nocturia) that most often map to OAB and voiding symptoms (hesitancy, weak stream, feeling of incomplete emptying, and interrupted stream) that are most often associated with BPH – decreased from 16.3 to 11.3. Finally, it was found that higher AUA-7 SI and voiding symptom scores at baseline were significantly associated with achieving a 3-point decline in total AUA-7 SI score (p < 0.0001). In all, this study suggests that tamsulosin may be an effective drug for OAB among men; future, prospective studies may further clarify these data.

Self-obtained vaginal swabs are not inferior to provider-performed endocervical sampling for Emergency Department diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis

1. Among patients presenting in the emergency setting for possible sexually transmitted infection, a self-obtained vaginal swab was found to be non-inferior to provider-performed endocervical sampling for the diagnosis of Neisseria gonorrhoeae and Chlamydia trachomatis.

Evidence Level Rating: 1 (Excellent)

Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) are the two most common sexually transmitted infections (STI) reported in the U.S. In the emergency setting, NG/CT is diagnosed via nucleic acid amplification test (NAAT), with the most common method of collection being provider-performed endocervical sampling (PPES). However, PPES may be uncomfortable, intrusive, or refused by some patients. As such, this prospective cohort study sough to establish whether self-obtained vaginal swabs (SOVS) were non-inferior to PPES for the diagnosis of NG/CT. A minimum sensitivity of 90% was established for SOVS to be considered clinically non-inferior to standard PPES. 515 patients were included for analysis (mean [SD] age = 30.7 [9.9] years). The majority of patients (95%) reported at least one vaginal/pelvic/urinary symptom, and 45% had a prior history of STI. Patients underwent both PPES and SOVS; 29 had infection with NG, 47 with CT, and 10 with both. It was found that SOVS had a sensitivity of 95% (95% CI 88% to 99%) for the detection of NG/CT when compared with PPES. There were three false-negative CT diagnoses and one false-negative NG diagnosis. With regards to organism-specific results, SOVS had a sensitivity of 97% (95% CI 87% to 100%) for NG and 94% (95% CI 84% to 99%) for CT. Thus, the non-inferiority of SOVS to PPES for the diagnosis of NG/CT in the emergency setting was established. It should be emphasized that SOVS was not proposed as a replacement for pelvic exams; indeed, a comprehensive physical examination remains of the utmost importance, especially for undifferentiated patients in an emergency setting. Rather, SOVS has the potential to optimize workflow in the emergency setting by allowing for earlier collection of samples and more timely initiation of treatment.

Association of potent and very potent topical corticosteroids and the risk of osteoporosis and major osteoporotic fractures

1. Among a large cohort of Danish adults, the use of potent or very potent topical corticosteroids was found to be associated with an increased risk of osteoporosis and major osteoporotic fracture.

Evidence Level Rating: 2 (Good)

It is well established that in their systemic and inhaled forms, corticosteroids have a negative impact on bone remodeling, increasing the risk of fracture and osteoporosis when given continuously or in high doses. The use of topical corticosteroids (TCSs) can also have negative systemic effects; however, whether their use increases the risk of osteoporosis and major osteoporotic fracture (MOF) is largely unknown. This nationwide retrospective cohort study from Denmark included 723,251 adults (mean [SD] age = 52.8 [19.2] years, 52.8% female) treated with either potent or very potent TCSs. Filled prescription data were converted in equipotent doses to mometasone furoate (1 mg/g). Included participants were treated with the equivalent of at least 200 g of mometasone. The primary outcome was a diagnosis of osteoporosis or MOF. 25.8% of participants were exposed to 500-999 g of mometasone; 15.4% to 1,000-1,999 g; 13.0% to 2,000-9,999 g; and 1.9% to at least 10,000 g. After adjustment, exposure (≥ 500 g vs. 200-499 g) to potent or very potent TCSs was significantly associated with an increased risk of both osteoporosis (HR 1.08, 95% CI 1.05 to 1.11) and MOF (HR 1.05, 95% CI 1.03 to 1.07). The risk of both osteoporosis and MOF was found to increase in a dose-dependent manner. In all, the population-attributable risk was found to be 4.3% (95% CI 2.7% to 5.8%) for osteoporosis and 2.7% (95% CI 1.7% to 3.8%) for MOF. This study demonstrated that the use of high cumulative amounts of potent or very potent TCSs was associated with an increased risk of both osteoporosis and MOF. Given the widespread use of TCSs worldwide, such findings are of public health importance and should help inform new treatment strategies.

Diagnostic accuracy of the Panbio SARS-CoV-2 antigen rapid test compared with RT-PCR testing of nasopharyngeal samples in the pediatric population

1. Among a pediatric cohort, rapid antigen testing for SARS-CoV-2 infection was found to have limited accuracy when compared with reverse-transcriptase polymerase chain reaction testing.

Evidence Level Rating: 2 (Good)

Since the start of the COVID-19 pandemic, reverse-transcriptase polymerase chain reaction (RT-PCR) testing performed on nasopharyngeal swabs has been the most widely used means of establishing the presence of infection. The Panbio™ COVID-19 Antigen (Ag) Rapid Test Device by Abbott is a simple, rapid test that can detect the virus in nasopharyngeal samples in as little as five minutes. There is, however, a paucity of evidence concerning the accuracy of the rapid antigen test in the pediatric population. This study included 1,620 pediatric patients age 0 to 16 years with symptoms compatible with SARS-CoV-2 infection of ≤ 5 days of evolution. Two nasopharyngeal swabs were obtained from each participant, one tested with RT-PCR and the other tested with Abbott’s Panbio™ COVID-19 Ag Rapid Test Device. Among the patients tested, 77 were positive by RT-PCR, 38 by Panbio™ COVID-19 Ag Rapid Test Device, and 35 by both. Discordant results occurred in 45 rapid tests as compared with RT-PCR: 3/1,543 (0.2%) false-positive antigen tests and 42/77 (54.4%) false-negative antigen test results were found. As such, it was determined that evidence of a systemic difference exists between the results of the two testing modalities (p = 1.47 • 10^-08); a moderate agreement between the two tests was found (k = 0.6). The overall sensitivity and specificity of the Panbio™ among this pediatric population was 45.4% and 99.8%, respectively. In all, this study showed that the Panbio™ COVID-19 Ag Rapid Test Device has limited accuracy in diagnosing SARS-CoV-2 infection of ≤ 5 days of evolution among children. In particular, the high proportion of false-negative test results may have important public health implications by failing to isolate contagious individuals; initiation of treatment may also be affected by false-negative testing. More work is needed to understand these findings.

Multimodal analgesic strategies for trauma: A pragmatic Randomized Clinical Trial

1. A multimodal pain regimen using generic medications reduced opiate exposure and achieved adequate pain control for adults following trauma.

Evidence Level Rating: 1 (Excellent)

Effective strategies that relieve acute pain without heavy reliance on opiates are needed for patients. This unblinded, randomized, comparative effectiveness trial compared two multimodal pain regimens (MMPR). Patients with acute pain in the setting of trauma were randomized to receive either the originally developed MMPR – consisting of IV, followed by oral, acetaminophen, 48 hours of celecoxib and pregabalin followed by naproxen and gabapentin, scheduled tramadol, and as needed oxycodone – or a generic MMPR, termed MAST MMPR – consisting of oral acetaminophen, naproxen, gabapentin, lidocaine patches, and as needed opiates. The primary outcome was oral morphine milligram equivalents (MME) per day. 1,561 patients presenting to a busy, urban center with trauma were included – 787 to the MMPR regimen (median [IQR] age = 44 (29-63) years, 68% male) and 774 to the MAST MMPR regimen (median [IQR] age = 45 (28-62) years, 67% male). The patients in both cohorts did not differ significantly with regards to demographics, medical history, or presenting injury causing pain. Patients in the MAST MMPR cohort had lower daily opiate exposure when compared with the MMPR cohort (34 MME/day vs. 48 MME/day, p < 0.001). Additionally, patients in the MAST MMPR cohort had a lower total MME exposure (164 MME vs. 218 MME, p < 0.001) as well as a lower rate of opiate prescribing at discharge (62% vs. 67%, p = 0.029). Of note, there was no clinically significant difference in pain scores between the two cohorts. In all, this study demonstrated that for the management of acute pain, a dynamic pain control strategy relying on generic medications is not only opiate sparing but also reduces opiate prescribing at discharge. These data underscore the value of these widely available, opiate-sparing regimens for patients with acute pain.

Image: PD

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