Characterising the safety of clomiphene citrate in male patients through prostate-specific antigen, haematocrit, and testosterone levels.

OBJECTIVE: To determine the safety profile of clomiphene citrate (CC) in men being treated for hypogonadism or infertility by measuring prostate-specific antigen (PSA), haematocrit (Hct), and testosterone levels. PATIENTS AND METHODS: We identified patients presenting to our institution who were placed on CC, 50 mg every day or every other day, for male infertility and/or symptomatic hypoandrogenism between September 2013 and April 2016. Patients with documented exogenous testosterone, human chorionic gonadotrophin, or anastrozole use within 2 weeks of baseline evaluations were excluded. Our primary outcomes were the effects of CC on PSA, Hct, and total testosterone levels evaluated at the 3, 6, 9, or 12 months of follow-up. Outcomes were averaged within patients across visits and summarised by mean, median, range, standard deviation (SD) and the 95% confidence interval (CI) for the mean. RESULTS: A total of 77 patients had recorded PSA, Hct, and/or testosterone values. The mean (SD, range) age and body mass index was 34 (6, 22-51) years and 31 (6, 22-52) kg/m2 , respectively. The mean (SD) follow-up was 358 (29) days. Within this group, CC concentration was changed in 24 patients (31%) and was discontinued in 24 patients (31%). The median (range) duration of CC therapy before discontinuation was 127 (44-161) days. The use of CC significantly raised both mean total and bioavailable testosterone levels by 200 ng/dL and 126 ng/dL, respectively (P < 0.001). This increase in testosterone had significant clinical effects with improvements in Androgen Deficiency in Aging Male questionnaire scores (P < 0.01) but not Sexual Health Inventory for Men scores. CC had no effect on mean PSA (1 ng/dL, 95% CI 0.8-1.1) or Hct (49%, 95% CI 41-53) levels, which were within normal ranges. CONCLUSIONS: As more men are placed on CC for infertility or hypogonadism, characterising the safety effect profile becomes important. Our study found that CC significantly increased testosterone levels without changing PSA or Hct values. Because the biochemical response to CC can vary, we suggest scheduling laboratory evaluation at regular intervals; however, ordering routine assessment of PSA and Hct may not be necessary.

Hormone-Based Treatments in Subfertile Males.

Subfertility is defined as the condition of being less than normally fertile though still capable of effecting fertilization. When these subfertile couples seek assistance for conception, a thorough evaluation of male endocrine function is often overlooked. Spermatogenesis is a complex process where even subtle alterations in this process can lead to subfertility or infertility. Male endocrine abnormalities may suggest a specific diagnosis contributing to subfertility; however, in many patients, the underlying etiology is still unknown. Optimizing underlying endocrine abnormalities may improve spermatogenesis and fertility. This manuscript reviews reproductive endocrine abnormalities and hormone-based treatments.

Open versus minimally-invasive surgical techniques in pediatric renal tumors: A population-level analysis of in-hospital outcomes.

INTRODUCTION: Minimally-invasive surgery (MIS) has been adopted slowly in pediatric oncology. We attempted to describe contemporary national trends in MIS use; we hypothesized that adolescents (who are more likely to have relatively small renal cell carcinomas) would have a higher proportion of MIS than younger children (who are more likely to have relatively large Wilms tumors) and that this relationship would vary by region. OBJECTIVE: To explore whether pediatric urologic oncology outcomes vary by patient age or by surgical technique. METHODS: We queried the 1998-2014 National Inpatient Sample (NIS) and included encounters in children aged ≤ 18 y, ICD-9 diagnostic code for renal tumor, and procedure code for open or MIS partial or radical nephrectomy. All analyses used weighted descriptive statistics and outcomes are compared based on age group (10 y) or surgery type; Wald-Chi square test was used for differences in proportions and unadjusted weighted ANOVA was used to test for differences in means. RESULTS: 9259 weighted encounters were included; 91% were <10 years old and 50.7% were female. MIS surgery accounted for 1.8% of encounters; there was a difference in proportions by age group (1% <9 y vs. 9.9% >9 y, p < 0.01). The proportion of surgery type was similar across regions within age groups, however. Complications occurred in 13.3% of encounters; mean inpatient length of stay was 8.9 days (SD: 0.3); mean cost was $ 34,457.68 (SD: $1197.00). There was no evidence of a difference between surgery type and proportion of post-operative complications, mean inpatient length of stay or mean inpatient cost. DISCUSSION: The admission-based, retrospective design of NIS left us unable to assess long-term outcomes, repeated admissions, or to track a particular patient across time; this is particularly relevant for oncologic variables on interest such as tumor stage or event-free survival. We were similarly limited in evaluating the effect of pre-surgical referral patterns on patient distributions. CONCLUSION: In this preliminary descriptive analysis, MIS techniques were infrequently used in children, but there was a higher proportion of MIS use among adolescents. There were similar proportions of surgery type across geographic regions within the United States. Whether this infrequent usage is appropriate is as yet unclear given the lack of Level I evidence regarding the relative merits of MIS and open surgery for pediatric and adolescent renal tumors.

Cadaveric Laboratory Simulation Training of Male Stress Urinary Incontinence Treatment Improves Trainee Knowledge and Confidence.

OBJECTIVE: To assess whether a focused, simulation training course can improve trainee surgical knowledge and confidence in the treatment of male stress urinary incontinence. MATERIALS AND METHODS: Urology residents participated in a prosthetic education course as part of the 2018 SUPS and SMSNA annual meeting. The course included didactic lectures and a hands-on cadaveric laboratory. Participants completed questionnaires before and after the lab (2 weeks and 6 months) to assess procedural knowledge and confidence. Analysis of lab responses was performed using the Wilcoxon signed rank test for matched pairs. RESULTS: Thirty-two residents (median age 29, range 27-34) participated in the course. The majority were postgraduate year 4 (63%) or postgraduate year 5 (20%). Most participants reported minimal AUS or sling experience with 50% and 94% reporting less than 5 cases, respectively. Overall score from the knowledge assessment improved significantly between the pre-lab versus 2-week post-lab (P = .02) and pre-lab versus 6-month post-lab (P = .01). Similarly, procedural confidence improved between pre-lab vs 2-week post-lab (P < .001) and pre-lab versus 6-month post-lab (P < .001). Knowledge and confidence assessments were not different between year of residency training or pre-lab experience. CONCLUSIONS: Simulation training improves knowledge and confidence in prosthetic surgery for male stress incontinence. In the current climate of reduced exposure and limited availability of prosthetic educators, simulation courses can provide much needed educational value.

Outcomes of Urethroplasty to Treat Urethral Strictures Arising From Artificial Urinary Sphincter Erosions and Rates of Subsequent Device Replacement.

OBJECTIVE: To evaluate the success of urethroplasty for urethral strictures arising after erosion of an artificial urinary sphincter (AUS) and rates of subsequent AUS replacement. PATIENTS AND METHODS: From 2009-2016, we identified patients from the Trauma and Urologic Reconstruction Network of Surgeons and several other centers. We included patients with urethral strictures arising from AUS erosion undergoing urethroplasty with or without subsequent AUS replacement. We retrospectively reviewed patient demographics, history, stricture characteristics, and outcomes. Variables in patients with and without complications after AUS replacement were compared using chi-square test, independent samples t test, and Mann-Whitney U test when appropriate. RESULTS: Thirty-one men were identified with the inclusion criteria. Radical prostatectomy was the etiology of incontinence in 87% of the patients, and 29% had radiation therapy. Anastomotic (28) and buccal graft substitution (3) urethroplasty were performed. Follow-up cystoscopy was done in 28 patients (median 4.5 months, interquartile range [IQR]: 3-8) showing no urethral stricture recurrences. Median overall follow-up was 22.0 months (IQR: 15-38). In 27 men (87%), AUS was replaced at median of 6.0 months (IQR: 4-7) after urethroplasty. In 25 patients with >3 months of follow-up after AUS replacement, urethral complications requiring AUS revision or removal occurred in 9 patients (36%) and included subcuff atrophy (3) and erosion (6). Mean length of stricture was higher in patients who developed a complication after urethroplasty and AUS replacement (2.2 vs. 1.5 cm, P = .04). CONCLUSION: In patients with urethral stricture after AUS erosion, urethroplasty is successful. However, AUS replacement after urethroplasty has a high erosion rate even in the short-term.