Ambulatory Blood Pressure Parameters Among Men With Hypogonadism Treated With Testosterone Transdermal Therapy.

OBJECTIVE: Studies are needed to examine the effects of testosterone replacement therapy on ambulatory blood pressure (BP) parameters. This study assessed a testosterone transdermal system (TTS) using 24-hour ambulatory BP monitoring. METHODS: In a single-arm, noninferiority trial conducted at 41 US sites, 168 men (mean age: 56.2 years) with hypogonadism not receiving testosterone replacement therapy in the past 6 months were enrolled and received ≥1 study drug dose. Nightly TTS treatment was administered for 16 weeks (starting dose: 4 mg/d; min, max dose: 2, 6 mg/d) to achieve testosterone concentration of 400-930 ng/dL. The primary endpoint was mean change from baseline to week 16 in 24-hour systolic BP (SBP). Noninferiority was determined based on the upper bound of the 2-sided 95% CI <3.0 mmHg. RESULTS: Sixty-two men had ≥85% study drug compliance and a valid week 16 ambulatory BP monitoring session. Mean change from baseline to week 16 in 24-hour average SBP was 3.5 mmHg (95% CI, 1.2-5.8 mmHg; n = 62). Since the upper limit of the CI was >3 mmHg, an effect of TTS could not be ruled out. Mean changes were larger at daytime vs nighttime and in subgroups of men with vs without hypertension. Cardiovascular adverse events were rare (<2%) and nonserious; no major cardiovascular adverse events were reported. CONCLUSION: A meaningful effect of 16-week TTS treatment on 24-hour average SBP among men with hypogonadism could not be ruled out based on the study's noninferiority criterion. The magnitude of mean changes observed may not be clinically meaningful regarding cardiovascular events.

Bacterial Interactions as Detected by Pooled Antibiotic Susceptibility Testing (P-AST) in Polymicrobial Urine Specimens.

Introduction: Antimicrobial susceptibility is well characterized in monomicrobial infections, but bacterial species often coexist with other bacterial species. Antimicrobial susceptibility is often tested against single bacterial isolates; this approach ignores interactions between cohabiting bacteria that could impact susceptibility. Here, we use Pooled Antibiotic Susceptibility Testing to compare antimicrobial susceptibility patterns exhibited by polymicrobial and monomicrobial urine specimens obtained from patients with urinary tract infection symptoms. Methods: Urine samples were collected from patients who had symptoms consistent with a urinary tract infection. Multiplex polymerase chain reaction testing was performed to identify and quantify 31 bacterial species. Antibiotic susceptibility was determined using a novel Pooled Antibiotic Susceptibility Testing method. Antibiotic resistance rates in polymicrobial specimens were compared with those in monomicrobial infections. Using a logistic model, resistance rates were estimated when specific bacterial species were present. To assess interactions between pairs of bacteria, the predicted resistance rates were compared when a pair of bacterial species were present versus when just one bacterial species was present. Results: Urine specimens were collected from 3,124 patients with symptoms of urinary tract infection. Of these, multiplex polymerase chain reaction testing detected bacteria in 61.1% (1910) of specimens. Pooled Antibiotic Susceptibility Testing results were available for 70.8% (1352) of these positive specimens. Of these positive specimens, 43.9% (594) were monomicrobial, while 56.1% (758) were polymicrobial. The odds of resistance to ampicillin (p = 0.005), amoxicillin/clavulanate (p = 0.008), five different cephalosporins, vancomycin (p = <0.0001), and tetracycline (p = 0.010) increased with each additional species present in a polymicrobial specimen. In contrast, the odds of resistance to piperacillin/tazobactam decreased by 75% for each additional species present (95% CI 0.61, 0.94, p = 0.010). For one or more antibiotics tested, thirteen pairs of bacterial species exhibited statistically significant interactions compared with the expected resistance rate obtained with the Highest Single Agent Principle and Union Principle. Conclusion: Bacterial interactions in polymicrobial specimens can result in antimicrobial susceptibility patterns that are not detected when bacterial isolates are tested by themselves. Optimizing an effective treatment regimen for patients with polymicrobial infections may depend on accurate identification of the constituent species, as well as results obtained by Pooled Antibiotic Susceptibility Testing.

Safety and efficacy of a patient-controlled bladder management system for treating urinary retention in men.

AIMS: The CymActive™ Bladder Management System (BMS) is a self-retaining, intraurethral catheter with a patient-controlled magnetic valve that allows cyclical bladder filling and emptying, without external appliances. We determined the safety and efficacy of the BMS in men with urinary retention who required catheterization for more than 7 days. METHODS: Men requiring continuous drainage, bladder capacity less than 300 ml, history of prostatic or urethral surgery, or urethral length outside of defined limits, were excluded. Data were collected from patient diaries and weekly visits during catheterization for up to 30 days. The primary composite endpoint assessed four outcomes: placement, post-void residual volume (PVR) of 75 ml or less, adverse device-related events requiring early removal, and removal. RESULTS: Nine of 23 patients met all four criteria: eight of 18 non-neurogenic (7/11 prior Foley users and 1/7 without Foley experience) and one of five neurogenic spinal cord injury (SCI) patients. Secondary outcomes in non-neurogenic patients included: 17/18 successful insertions; of these, 16/17 average PVR of 75 ml; successful valve openings and closings ≥ 95% of more than 1,400 voids; and minimal leakage. Four of five SCI patients discontinued within 7 days. Cystourethroscopy after removal revealed no marked inflammation or mucosal changes. CONCLUSIONS: This pilot study demonstrated the BMS is potentially useful, convenient, and safe for appropriate patients. A follow-up study will better define the characteristics of patients who benefit from this device and examine whether the use of antimuscarinic agents improves outcomes. Neurourol. Urodynam. 35:630-635, 2016. © 2015 Wiley Periodicals, Inc.

Erectile function after posterior urethroplasty for pelvic fracture-urethral distraction defect injuries.

OBJECTIVE: To determine the specific effect of pelvic fracture-urethral distraction defect (PFUDD) injuries on erectile function (EF) in men after pelvic fractures, and to compare EF to that found in other studies of men who sustained pelvic fractures, as currently the relationship between erectile dysfunction (ED) and PFUDD has not been elucidated using validated questionnaires. PATIENTS AND METHODS: With approval from the institutional review board, patients who sustained a PFUDD injury and had a posterior urethroplasty from 1990 to 2004 were identified from a database. Patients were contacted by telephone, and those who were willing to participate were given the International Index of Erectile Function (IIEF) questionnaire. Using unpaired Student's t-tests, IIEF scores were compared to normal controls, and to results of other studies of men sustaining pelvic fractures. RESULTS: In all, 26 men completed the IIEF, among whom EF was compromised in 14 (54%), including eight with severe ED (31%). Orgasmic function and ejaculation was maintained. Men with a PFUDD had significantly worse EF than men in other series with pelvic fractures. CONCLUSIONS: Men who sustain a PFUDD are at significantly greater risk of ED than those with no urethral distraction injury. Men with PFUDD injuries represent a target population for early penile rehabilitation programmes.

Ejaculatory profiles and fertility in men after posterior urethroplasty for pelvic fracture-urethral distraction defect injuries.

OBJECTIVE: In men who sustain a pelvic fracture-urethral distraction defect (PFUDD) injury, repairing the urethra involves a complicated urethral anastomosis located posteriorly at the junction of the membranous and prostatic urethra. In this study we performed a post- operative semen analysis and questionnaire study to determine the effect of PFUDD injuries and PFUDD repair on ejaculatory function and fertility in these men. PATIENTS AND METHODS: With institutional review board approval, patients who had PFUDD repairs by one surgeon from 1990 to 2004 were identified from a database. Patients were contacted and given a questionnaire eliciting details about their ejaculatory function and history of fertility. Those interested in future paternity were asked to provide semen for analysis. RESULTS: In all, 32 men were contacted; all claimed to have antegrade ejaculation, although five reported having a lower ejaculatory volume than before their injury, and one claimed that his ejaculate was delayed. We assessed fertility in 19 men, six of whom had either infertility or abnormal semen analyses. CONCLUSIONS: All men in the present series who had PFUDD injuries repaired had antegrade ejaculation. Although six of 19 had either infertility or an abnormal semen analysis, it appears that the risk of damage to the ejaculatory ducts from either a PFUDD or the subsequent urethral reconstruction is low. However, other associated injuries at the time of the pelvic fracture might place these men at greater risk of infertility.

Current and future techniques of neuromodulation for bladder dysfunction.

Recent increase in the use of neuromodulation for the treatment of urinary urgency and frequency, urge incontinence, and nonobstructive urinary retention has coincided with improved knowledge of micturition physiology and concurrent technologic advances in nerve stimulation. Currently, the most common technology for bladder neuromodulation involves stimulation through the S3 foramen, or sacral neuromodulation, although other techniques of neuromodulation continue to be explored. Despite many advances in neuromodulation, the exact mechanism of action remains uncertain. Additionally, which patients will respond to neuromodulation remains unclear, and although there is a standard method for testing, this procedure is invasive and expensive. As we continue to improve patient selection criteria and better understand the mechanism of action, the efficacy and patient satisfaction should continue to increase. Currently, most patients considered for implantation with a neuromodulator are those unresponsive to other conservative treatments for bladder dysfunction.

The effect of bulbar urethroplasty on erectile function.

PURPOSE: Theoretically bulbar urethroplasty has the potential to adversely affect potency, involving as it does dissection in proximity to the corporeal bodies and erectile neurovascular structures. We prospectively examined the effect of various bulbar urethroplasties on erectile function. MATERIALS AND METHODS: Prior to undergoing urethroplasty, patients completed an International Index of Erectile Function questionnaire. Each patient repeated the International Index of Erectile Function at least 3 months postoperatively. One-sided t and Fisher's exact tests were used to compare preoperative and postoperative erectile function. RESULTS: A total of 25 men with an average age of 39 years (range 26 to 66) completed the study. Etiology of stricture was idiopathic in 20 patients and traumatic in 5. Stricture location was panbulbar in 5 patients, mid to posterior bulbar in 13 and mid to distal bulbar in 7. Eight men underwent anastomotic urethroplasty, 15 underwent augmented anastomotic repair using a buccal mucosal graft and 2 underwent a dorsal onlay. At a mean of 6.2 months of followup, average total International Index of Erectile Function went from 62.6 to 59.6 of 75 possible points and the average erectile function domain score went from 26.9 to 24.8 of 30 possible points. Neither of these differences attained significance (p = 0.29 and 0.13, respectively). A total of 25 men had an erectile function domain postoperative score of greater than 20 and 8 had a score of 20 or less. Men with a score of 20 or less were older (47 vs 36.8 years, p = 0.17) and had worse preoperative erectile function (20 vs 29, p = 0.11) than those with erectile function scores greater than 20, although these differences did not achieve significance. CONCLUSIONS: We report on men undergoing 4 variations of bulbar urethroplasty. Although the numbers are small, we found that such surgery had an insignificant effect on erectile function. Surgical complexity with long stricture excision and the use of a buccal graft did not influence outcome.

A statistical comparison of pad numbers versus pad weights in the quantification of urinary incontinence.

AIMS: Pad per day (PPD) usage is a frequently utilized measure of urinary incontinence. The 24-hour pad weight test (24PWT) is a reproducible test for quantifying incontinence volumes. We investigated whether PPD validly reports the magnitude of urinary incontinence. METHODS: This was a retrospective review of patients undergoing stress incontinence surgery from July 2002 to 2005. Inclusion criteria were a documented 24PWT and patient-reported PPD usage. Grams of urine loss per pad (GPP) provided a third measure of incontinence. Descriptive statistics and correlations between all variables and significance were noted. Factor analysis was performed on the three measures of leakage and age for all patients over age 50. RESULTS: One hundred forty-five male and 116 female patients met inclusion criteria. Correlated against 24PWT, GPP has the strongest association with a correlation of 0.80 for males and 0.88 for females. PPD has a weaker correlation of 0.64 for males and 0.61 for females (R2 = 0.38 overall). Factor analysis identified two components associated with incontinence. A "leakage" component correlated best with 24PWT and GPP. Additionally, an "age" component implies that despite stable 24PWT values, older patients increase GPP while PPD decreases. CONCLUSIONS: Self-reported PPD is an unreliable measure of incontinence as this variable only measures 38% of the variation of urinary incontinence volume. Patients at a given PPD level present with a wide range of 24PWT values. Older patients have higher per-pad leakage. Future incontinence studies should report 24PWT to ensure the most reliable and uniform data.

Sacral neuromodulation for the treatment of refractory urinary urge incontinence after stress incontinence surgery.

OBJECTIVE: This study was undertaken to evaluate the response to sacral neuromodulation in women with refractory, nonobstructive urinary urge incontinence after stress incontinence surgery. STUDY DESIGN: We reviewed the medical records of women in whom sacral neuromodulation was performed for worsening or de novo urinary urge incontinence after a stress incontinence procedure. All patients had undergone preliminary test stimulation. Demographics, surgical and urogynecologic history, including bladder diary and pad weight test, and urodynamic parameters were evaluated. RESULTS: Of 34 women, 22 (65%) responded to the test stimulation and underwent permanent lead implant. There was no difference between responders and nonresponders with respect to type of stress incontinence surgery. Incontinence or urodynamic parameters were not different between responders and nonresponders. Factors that were predictive of a positive response were women aged less than 55 years (P = .01), the test stimulation performed within 4 years of the stress incontinence procedure (P = .01), and evidence of pelvic floor muscle activity (P = .03). CONCLUSION: Sacral neuromodulation is a viable option for the treatment of refractory urinary urge incontinence that occurs after stress urinary incontinence surgery. Older women with no pelvic floor activity who are remote from their incontinence surgery may have a suboptimal response.

Management of male incontinence following artificial urinary sphincter failure.

PURPOSE OF REVIEW: The artificial urinary sphincter has been used successfully for the treatment of stress urinary incontinence in both male and female patients. Its most common use, however, is in men suffering from postprostatectomy incontinence. RECENT FINDINGS: The success rates, long-term durability, and patient satisfaction for the artificial urinary sphincter are high. The incidence of complications and adverse events remains low although they are sometimes unavoidable. SUMMARY: We believe that continence can be salvaged in the majority of men in whom the device fails or requires explantation and we present the logical analysis for device revision and relocation in this review.

Bladder dysfunction after bilateral ectopic ureterocele repair.

PURPOSE: We examined postoperative outcome, with emphasis on bladder function, in pediatric patients who underwent bilateral ectopic ureterocele repair. MATERIAL AND METHODS: We reviewed the records of 117 patients with orthotopic and ectopic ureteroceles treated between 1977 and 2000. Twelve of these patients had bilateral ectopic ureteroceles. All patients with bilateral ureteroceles were females 1 day to 2 years old at referral. Initial treatment was transureteral puncture in 6 cases, transurethral unroofing in 2 and extravesical bilateral reimplantation in 1. Of the remaining 3 patients the initial treatment was unilateral heminephroureterectomy in 1 and bilateral heminephroureterectomy in 2. Definitive treatment included bilateral upper to lower ureteroureterostomy, ureterocelectomy with trigonal and bladder neck reconstruction, and bilateral ureteroneocystotomy with or without tapering of the recipient ureter. In patients who underwent upper pole partial nephrectomy the distal upper pole ureter was removed in conjunction with trigonal surgery and ureteroneocystotomy. RESULTS: There was significant morbidity in this group of patients, including voiding dysfunction and poor bladder emptying with residual urine greater than 20% of bladder capacity in 7 of 10 patients studied by serial bladder ultrasonography. Urodynamic evaluation in 3 patients revealed increased bladder compliance and large volume residual urine. Of these 3 patients 2 perform clean intermittent catheterization. Recurrent symptomatic bacteruria was noted in 7 of the 12 patients. CONCLUSIONS: Patients undergoing bilateral ectopic ureterocele repair are at increased risk for postoperative voiding dysfunction. Whether this risk is present preoperatively or is a result of trigonal surgery is unclear.

Gastric transposition for esophageal replacement in children: experience with 41 consecutive cases with special emphasis on esophageal atresia.

OBJECTIVE: To evaluate the authors' experience with gastric transposition as a method of esophageal replacement in children with congenital or acquired abnormalities of the esophagus. SUMMARY BACKGROUND DATA: Esophageal replacement in children is almost always done for benign disease and thus requires a conduit that will last more than 70 years. The organ most commonly used in the past has been colon; however, most series have been fraught with major complications and conduit loss. For these reasons, in 1985 the authors switched from using colon interpositions to gastric transpositions for esophageal replacement in infants and children. METHODS: The authors retrospectively reviewed the records of 41 patients with the diagnoses of esophageal atresia (n = 26), corrosive injury (n = 8), leiomyomatosis (n = 5), and refractory gastroesophageal reflux (n = 2) who underwent gastric transposition for esophageal replacement. RESULTS: Mean +/- SE age at the time of gastric transposition was 3.3 +/- 0.6 years. All but two transpositions were performed through the posterior mediastinum without mortality or loss of the gastric conduit despite previous surgery on the gastric fundus in 8 (20%), previous esophageal operations in 15 (37%), and previous esophageal perforations in 6 (15%) patients. Complications included esophagogastric anastomotic leak (n = 15, 36%), which uniformly resolved without intervention; stricture formation (n = 20, 49%), all of which no longer require dilation; and feeding intolerance necessitating jejunal feeding (n = 8, 20%) due to delayed gastric emptying (n = 3), feeding aversion related to the underlying anomaly (n = 1), or severe neurological impairment (n = 4). No redo anastomoses were required. CONCLUSIONS: Gastric transposition reestablishes effective gastrointestinal continuity with few complications. Oral feeding and appropriate weight gain are achieved in most children. Therefore, gastric transposition is an appropriate alternative for esophageal replacement in infants and children.

Application of the principles of myotomy and strictureplasty for treatment of esophageal strictures.

BACKGROUND/PURPOSE: Strictures of the esophagus in the pediatric population may be congenital or acquired. Regardless of the etiology, the treatment goal is to relieve the symptoms and allow patients to eat normally. The cornerstone of nonoperative management is repeated esophageal dilatations. However, when nonoperative management fails, operative intervention becomes necessary. In this report the authors present 4 cases of severe upper esophageal strictures managed by applying the principles of myotomy and strictureplasty. METHODS: Retrospective review of 4 patients undergoing esophageal stricturotomy from January 1, 1993 to January 1, 2000 was conducted at Childrens Hospital Los Angeles, with a mean follow-up period of 5 years. RESULTS: Three of the 4 patients reported in this report are doing well and have not required any further surgical intervention. One patient in whom additional strictures developed has had a microvascularized free jejunal graft and also is doing well. CONCLUSIONS: Currently accepted surgical management of strictures includes resection of the affected segment with end-to-end anastomosis or esophageal replacement. The authors propose that before embarking on a long and technically hazardous operation, consideration should be given to stricturotomy. In cases of isolated strictures, this may be the preferred approach.