Demographics, Usage Patterns, and Safety of Male Users of Clomiphene in the United States.

PURPOSE: The aim of this study was to characterize the demographics, usage patterns and complication rates of clomiphene use in male patients. MATERIALS AND METHODS: We retrospectively analyzed male patients from ages 20 to 55 years old who were prescribed clomiphene citrate from 2001 to 2014 using the Truven Health MarketScan, a US claims database. We collected data regarding associated medical diagnoses, diagnostic testing, duration of use, and reported side effects including thrombotic events, vision problems, gynecomastia, mental disorders, liver disease, nausea, or skin problems. RESULTS: In total, 12,318 men took clomiphene and represented the primary study cohort, with a mean age of 37.8 years. The percentage of men prescribed clomiphene increased over the study period, as did the average age of clomiphene users. Associated diagnoses included male infertility (52.0%), testicular hypofunction (13.5%), erectile dysfunction (2.4%), and low libido (0.4%). Associated testing included semen analysis (43.7%), testosterone (23.5%), luteinizing hormone (19.3%), and follicle-stimulating hormone (21.1%) levels. The median time of clomiphene use was 3.6 months, with 63% of men stopping within 6 months. No increased risk of reported clomiphene side effects were apparent in men taking the medication. CONCLUSIONS: There is a rising prevalence of clomiphene usage without associated adverse side effects in the US. The variability in associated diagnoses, diagnostic testing, and duration of use suggest a need for greater awareness of the proper evaluation and treatment of the men who are prescribed clomiphene.

Using observational data for personalized medicine when clinical trial evidence is limited.

Randomized clinical trials are considered the preferred approach for comparing the effects of treatments, yet data from high-quality clinical trials are often unavailable and many clinical decisions are made on the basis of evidence from observational studies. Using clinical examples about the management of infertility, we discuss how we can use observational data from large and information-rich health-care databases combined with modern epidemiological and statistical methods to learn about the effects of interventions when clinical trial evidence is unavailable or not applicable to the clinically relevant target population. When trial evidence is unavailable, we can conduct observational analyses emulating the hypothetical pragmatic target trials that would address the clinical questions of interest. When trial evidence is available but not applicable to the clinically relevant target population, we can transport inferences from trial participants to the target population using the trial data and a sample of observational data from the target population. Clinical trial emulations and transportability analyses can be coupled with methods for examining heterogeneity of treatment effects, providing a path toward personalized medicine.

The Research Implications of Prostate Specific Antigen Registry Errors: Data from the Veterans Health Administration.

PURPOSE: We sought to characterize the effects of prostate specific antigen registry errors on clinical research by comparing cohorts based on cancer registry prostate specific antigen values with those based directly on results in the electronic health record. MATERIALS AND METHODS: We defined sample cohorts of men with prostate cancer using data from the Veterans Health Administration, including those with a prostate specific antigen value less than 4.0, 4.0 to 10.0, 10.0 to 20.0 and 20.0 to 98.0 ng/ml, respectively. We compared the composition of each cohort and overall patient survival when using prostate specific antigen values from the Veteran Affairs Central Cancer Registry vs the gold standard electronic health record laboratory file results. RESULTS: There was limited agreement among cohorts when defined by cancer registry prostate specific antigen values vs the laboratory file of the electronic health record. The least agreement of 58% was seen in patients with prostate specific antigen less than 4.0 ng/ml and greatest agreement of 89% was noted among patients with prostate specific antigen between 4.0 and 10.0 ng/ml. In each cohort patients assigned to a cohort based only on the cancer registry prostate specific antigen value had significantly different overall survival when compared with patients assigned based on registry and laboratory file prostate specific antigen values. CONCLUSIONS: Cohorts based exclusively on cancer registry prostate specific antigen values may have high rates of misclassification that can introduce concerning differences in key characteristics and result in measurable differences in clinical outcomes.

Urodynamics of men with urinary retention.

OBJECTIVES: To describe the urodynamic characteristics of men with urinary retention, and to show the diverse treatment plans based on urodynamic findings. METHODS: We carried out a 3-year retrospective review of men with urinary retention who were referred to our clinic for urodynamic evaluation. Men with a history of neurogenic voiding dysfunction or major pelvic surgery were excluded. Multichannel videourodynamic studies were carried out, and the subsequent treatment modality offered was recorded. RESULTS: A total of 67 men with urinary retention and a median age of 68 years underwent urodynamic evaluation. The median maximum flow rate was 3 mL/s, and the median detrusor pressure at maximum flow was 54 cm H2 O. Bladder outlet obstruction was diagnosed in 60%. Detrusor underactivity was present in 73% according to the bladder contractility index; however, just 29% were classified as having detrusor underactivity according to isometric detrusor pressure, an alternative measure of contractility. A total of 76% of patients had low detrusor reserve (<20 cm H2 O). Based on urodynamic findings, just 57% of patients were offered de-obstructive surgery. CONCLUSIONS: In the present cohort, just 60% of men with urinary retention showed urodynamic evidence of bladder outlet obstruction. Depending on how contractility is measured (bladder contractility index vs isometric detrusor pressure), the rate of detrusor underactivity varies. The majority of men with retention had a low detrusor reserve. Given the wide spectrum of urodynamic findings in men with retention, surgical intervention might not be necessary for all. Furthermore, a careful consideration of urodynamics can assist in the selection of optimal treatment.

The Relationship Between Offspring Sex Ratio and Vasectomy Utilization.

OBJECTIVE: To determine if there was an association between vasectomy utilization and offspring sex ratio (male offspring : total offspring), as offspring sex preference may have an impact on family planning in the United States. METHODS: Using data from the National Institutes of Health-AARP Diet and Health Study, we calculated the number of sons and daughters of all men stratified by vasectomy status. We utilized a logistic regression model to determine if vasectomy utilization varies based on offspring sex ratio while accounting for known factors that impact vasectomy utilization. RESULTS: Of these men, 30,927 (30.8%) underwent vasectomy. Marital status, race, age, education level, region or state, and number of offspring were all significantly correlated with vasectomy utilization (P < .01). The sex ratio for vasectomized fathers (51.3%) was significantly higher than for fathers who had not undergone vasectomy (50.7%, P < .01). This difference remained even after we stratified by the total number of offspring: vasectomized men with 4 or more children had a sex ratio of 947 girls per 1000 boys, whereas the no vasectomy group had a sex ratio of 983 girls per 1000 boys (P < .01). For men with at least 2 children, each additional son increased the likelihood of vasectomy by 4% (P < .01), whereas each additional daughter led to a 2% decrease in vasectomy utilization (P = .03). CONCLUSION: Vasectomized fathers have a higher proportion of sons compared with non-vasectomized fathers, suggesting that offspring sex ratio is associated with a man's decision to undergo vasectomy. Further research is indicated to understand how offspring sex ratio impacts a man's contraceptive decisions.

Relationship between Vasectomy and Sexual Frequency.

INTRODUCTION: Men who are considering vasectomy as a means of contraception may have significant anxiety about their future sexual potency. As a result, couples may choose other forms of contraception with lower efficacy. AIM: We sought to determine the relationship between vasectomy and the frequency of sexual intercourse. METHODS: We analyzed data from cycles 6 (2002) to 7 (2006-2008) of the National Survey of Family Growth to compare the frequency of sexual intercourse of men who had undergone vasectomy with men who had not. Analysis was performed using data from male and female responders, and excluded men who had never had sex and those below age 25. We constructed a multivariate logistic regression model to adjust for demographic, socioeconomic, reproductive, and health factors. MAIN OUTCOME MEASURE: The main outcome measure was the sexual frequency in the last 4 weeks. RESULTS: Among male responders, a total of 5838 men met criteria for our study; 353 had undergone vasectomy. For vasectomized men, the average frequency of sexual intercourse was 5.9 times per month compared with 4.9 times for nonvasectomized men. After adjusting for age, marital status, race, education, health, body mass index, children, and income, vasectomized men had an 81% higher odds (95% confidence interval [CI] 6-201%) of having intercourse at least once a week compared with nonvasectomized men. A total number of 5211 female respondents reported 670 of their partners had undergone vasectomy. For partners of vasectomized men, the average frequency of intercourse was 6.3 times per month, compared with 6.0 times for partners of nonvasectomized men. After adjustment, women with vasectomized partners had a 46% higher odds (95% CI 5-103%) of having sexual intercourse at least once a week compared with women with nonvasectomized partners (P = 0.024). CONCLUSION: Vasectomy is not associated with decreased sexual frequency. This finding may be helpful to couples as they consider contraceptive options.

Patterns of urinary catheter consults in a tertiary care hospital.

INTRODUCTION: We reviewed the consultation patterns for difficult urethral catheter placement in tertiary care hospitals and developed a treatment algorithm for this common request. MATERIALS AND METHODS: We identified all urethral catheter consults obtained by urology residents at three tertiary care hospitals from October 2009 through October 2010. Only consults for inability to place urethral catheter by the referring team were included; hematuria or clot retention were excluded. Patient age, date of consultation, consulting service, prior urologic history, initial number of attempts, and final outcome were recorded. RESULTS: Eighty-one consults were recorded. Seventy-seven (96%) were male; the median age was 65 years. The most common consulting services were internal medicine (35%), intraoperative consults (17%), and the intensive care unit (17%). In 90% of cases, an initial attempt at catheter placement was attempted; 62% of these were made by nurses. Over half of patients had known urologic pathology. In 70% of cases, successful placement without other adjuncts was achieved by the urology resident. Twenty percent of patients required cystoscopic manipulation; nine percent required suprapubic tube placement. CONCLUSIONS: Catheterization was achieved without adjunct procedures in the majority of consults. These results support an algorithm in which all patients without a prior history of lower urinary tract pathology should undergo an initial placement attempt by the primary service physician. They also underscore the need for educational efforts to improve non-urologists' comfort level with placement of a standard Foley or Coudé catheter.