Casey G. Kowalik

Evaluation of the axonics modulation technologies sacral neuromodulation system for the treatment of urinary and fecal dysfunction.

ABSTRACT Introduction: Sacral neuromodulation (SNM) remains one of the few effective treatments for refractory bladder and bowel dysfunction. However, SNM is associated with frequent need for surgical intervention, in many cases because of a failed battery. A rechargeable SNM system, with a manufacturer-reported battery life of 15 years or more, has entered post-market clinical testing in Europe but has not yet been approved for clinical testing in the United States. Areas covered: We review existing neuromodulation technologies for the treatment of lower urinary tract and bowel dysfunction and explore the limitations of available technology. In addition, we discuss implantation technique and device specifications and programming of the rechargeable SNM system in detail. Lastly, we present existing evidence for the use of SNM in bladder and bowel dysfunction and evaluate the anticipated trajectory of neuromodulation technologies over the next five years. Expert commentary: A rechargeable system for SNM is a welcome technological advance. However surgical revision not related to battery changes is not uncommon. Therefore, while a rechargeable system would be expected to reduce costs, it will not eliminate the ongoing maintenance associated with neuromodulation. No matter the apparent benefits, all new technologies require extensive post-market monitoring to ensure safety and efficacy.

Desmopressin acetate nasal spray for adults with nocturia

ABSTRACT Introduction: Nocturia impacts 70% of individuals over age 70 years. Nocturnal polyuria is present in up to 88% of adults with nocturia, however, treatment options for reducing nighttime urine production have historically been limited to behavioral modification and off label use of timed diuretics and desmopressin. NoctivaTM (desmopressin acetate nasal spray, DANS, Serenity Pharmaceuticals, LLC) is a novel formulation of desmopressin approved by the Food and Drug Administration for the treatment of nocturia due to nocturnal polyuria in March 2017. Areas covered: Incidence and etiology of nocturia, currently available therapies (approved and off label), and pharmacokinetic, efficacy, and safety data associated with DANS. Expert commentary: DANS has been studied for the treatment of nocturia in adults over age 50 without contraindications to the use of desmopressin. 49% receiving the higher clinical dose experienced ≥50% reduction in nocturnal voids in clinical trials vs. 30% with placebo. Although nadir serum sodium <135 mmol/L was not uncommon (14%), the incidence of sodium ≤125 mmol/L was rare (1%). DANS therefore appears to benefit a significant subset of patients with nocturia while maintaining an acceptable risk profile. Given the risks of hyponatremia, education of patients and prescribers in contraindications and the importance of monitoring are paramount.

Road to recovery after transvaginal surgery for urethral mesh perforation: evaluation of outcomes and subsequent procedures

Introduction and hypothesisUrethral injury resulting from transvaginal mesh slings is a rare complication with an estimated incidence of <1%. Our objective was to review the surgical management and functional outcomes of women presenting with urethral mesh perforation following midurethral sling (MUS) placement.MethodsThis was a retrospective multicenter review of women who from January 2011 to March 2016 at two institutions underwent mesh sling excision for urethral perforation with Female Pelvic Medicine and Reconstructive Surgery fellowship-trained surgeons. Data comprising preoperative symptoms, operative details, and postoperative outcomes were collected by telephone (n 13) or based on their last follow-up appointment.Results obtainedNineteen women underwent transvaginal sling excision for urethral mesh perforation. Eight (42%) patients had undergone previous sling revision surgery. Sixty percent of women had resolution of their pelvic pain postoperatively. At follow-up, 92% reported urinary incontinence (UI), and three had undergone five additional procedures for vaginal prolapse mesh exposure (n 1), incontinence (onabotulinum toxin injection n 1, rectus fascia autologous sling n 1), prolapse (colpopexy n 1), and pain (trigger-point injection n 1). Patient global impression of improvement data was available for 13 patients, of whom seven (54%) rated their postoperative condition as Very much better or Much better.ConclusionsThe management of urethral mesh perforation is complex. Most women reported resolution of their pelvic pain and a high rate of satisfaction with their postoperative condition despite high rates of incontinence.

Women undergoing third line overactive bladder treatment demonstrate elevated thermal temporal summation

Purpose: We sought to determine whether women with overactive bladder who required third line therapy would demonstrate greater central sensitization, indexed by temporal summation to heat pain stimuli, than those with overactive bladder. Materials and Methods: We recruited 39 women with overactive bladder from the urology clinic who were planning to undergo interventional therapy for medication refractory overactive bladder with onabotulinumtoxinA bladder injection or sacral neuromodulation. We also recruited 55 women with overactive bladder who were newly seen at our urology clinic or who responded to advertisements for study participation. Participants underwent quantitative sensory testing using a thermal temporal summation protocol. The primary study outcome was the degree of temporal summation as reflected in the magnitude of positive slope of the line fit to the series of 10 stimuli at a 49C target temperature. We compared the degree of temporal summation between the study groups using linear regression. Results: Women in the group undergoing third line therapy showed significantly higher standardized temporal summation slopes than those in the nontreatment group (&bgr; = 1.57, 95% CI 0.18–2.96, t = 2.25, p = 0.027). On exploratory analyses a history of incontinence surgery or hysterectomy was associated with significantly greater temporal summation. Conclusions: In this study the degree of temporal summation was elevated in women undergoing third line overactive bladder therapy compared to women with overactive bladder who were not undergoing that therapy. These findings suggest there may be pathophysiological differences, specifically in afferent nerve function and processing, in some women with overactive bladder.

Painful bladder symptoms related to somatic syndromes in a convenience sample of community women with overactive bladder symptoms

Purpose: We investigated the relationship of painful bladder filling and urinary urgency to somatic and chronic pain symptoms in women with overactive bladder without an interstitial cystitis/bladder pain syndrome diagnosis. Materials and Methods: Women who met overactive bladder criteria based on symptoms were recruited, including 183 (83.9%) from the community and 35 (16.1%) from the urology clinic to complete validated questionnaires assessing urinary symptoms, somatic symptoms and pain syndromes. Participants were categorized into 1 of 3 groups, including 1) neither symptom, 2) either symptom or 3) both symptoms, based on their reports of painful urinary urgency and/or painful bladder filling. Multivariable regression analyses were performed to determine factors predictive of having painful urgency and/or painful filling. Results: Of 218 women with overactive bladder 101 (46%) had neither painful bladder filling nor urinary urgency, 94 (43%) had either symptom and 23 (11%) had both symptoms. When controlling for age, women with either or both urological pain symptoms were more likely to have irritable bowel syndrome, chronic pelvic pain and temporomandibular disorder than women in the neither group. Additionally, these women had higher pain intensity and somatic symptoms scores than women with neither symptom. Conclusions: The majority of women with overactive bladder who had not been diagnosed with interstitial cystitis/bladder pain syndrome reported painful urgency and/or painful filling. Experiencing painful urgency and/or filling was associated with an increased somatic symptom burden and greater pain intensity. These findings support the hypothesis that overactive bladder and interstitial cystitis/bladder pain syndrome diagnoses may represent a continuum of bladder hypersensitivity.

Toileting behaviors of adult women: What is healthy?

Purpose: The objective of this study was to assess toileting behaviors in community dwelling women. Materials and Methods: Women 18 years old or older were recruited through a national registry of research volunteers. They were asked to complete validated questionnaires assessing urinary symptoms and toileting behaviors, specifically place preference for voiding, convenience voiding, delayed voiding, straining during voiding and position preference for voiding. The PPBC (patient perception of bladder condition) was administered to assess the participant impression of bladder health. Analyses were done to determine the prevalence of each toileting behavior reported to occur sometimes or more often as well as differences in toileting behaviors in women with vs without self-perceived bladder problems based on the PPBC response. Results: The 6,695 women who completed the questionnaires were 18 to 89 years old (mean ± SD age 41.4 ± 15). Of the women 79.9% identified as white and 71.0% were college educated. Of the women 6,613 (98.8%) reported a place preference for voiding. The 3,552 women (53.1%) who reported a bladder problem were more likely to report convenience voiding, delayed voiding and strained voiding behaviors. While 6,657 women (99.4%) reported sitting to void at home only 5,108 (76.2%) reported sitting when using public toilets. Conclusions: Certain toileting behaviors, of which some may be considered unhealthy, were common in this sample of women and most were associated with a perception of bladder problems. Voiding positions other than sitting were frequently used when away from home. These data have important implications for defining bladder health and implementing behavior based interventions for women with lower urinary tract symptoms.

Pharmacologic Management of Neurogenic Lower Urinary Tract Dysfunction

Lower urinary tract function requires complex and coordinated signaling between central and peripheral nervous systems. In patients with neurologic lesions, the development of neurogenic lower urinary tract dysfunction (NLUTD) can include neurogenic detrusor overactivity (NDO), detrusor areflexia, detrusor sphincter dyssynergia (DSD), or sphincter underactivity depending on the locations and extent of the lesion. The pharmacologic management of NLUTD is reviewed in this chapter following a brief summary of neurologic control of micturition and assessment of NLUTD. Antimuscarinics with or without intermittent catheterization are the first-line management of NDO, but mirabegron is a newer agent that has also shown efficacy in this population. Botulinum toxin A (BTX-A) injections into the detrusor muscle can be considered if medical therapy fails. Medical therapy for DSD has not been demonstrated as efficacious, but intrasphincteric BTX-A can be considered as an alternative to sphincterotomy. No medical therapy has been shown effective for the management of detrusor areflexia or sphincter underactivity. Lifelong follow-up is necessary to prevent the development of secondary complications, such as renal failure.

Effects of Pelvic Organ Prolapse on the Bladder

Purpose of ReviewTo assess how pelvic organ prolapse (POP) and treatment affect bladder function.Recent FindingsThere is significant overlap between POP and bladder symptoms, including urinary incontinence and overactive bladder. POP may result in bladder outlet obstruction (BOO) secondary to urethral kinking, which may result in overactive bladder (OAB), dysfunctional voiding, and occult or de novo stress urinary incontinence (SUI). Improvements in obstructive symptoms and dysfunctional voiding after POP surgery suggest that pelvic floor reconstruction restores pelvic floor anatomic structure and function. Furthermore, correction of anatomic structure also seems to improve OAB symptoms, although a direct causative link has yet to be established.SummaryPelvic floor syndromes should be interpreted as a whole. POP, OAB, urinary incontinence, BOO, and dysfunctional voiding are all part of pelvic floor syndromes, coexisting and interacting to manifest different symptoms before and after POP treatment.

Treatment of Pelvic Floor Disorders Following Neobladder

Radical cystectomy remains the gold standard treatment for organ-confined high-grade recurrent or muscle-invasive bladder cancer. Orthotopic neobladder urinary diversion following cystectomy represents an option for patients wishing for continent urinary diversion. Female patients who undergo radical cystectomy with orthotopic bladder substitution are at risk for developing both common and neobladder-specific disorders of the pelvic floor, including urinary incontinence, hypercontinence, vaginal prolapse, and neobladder-vaginal fistula. Each of these sequelae can have significant impact on the patient’s quality of life. Due to the increased frequency of orthotopic neobladder creation in women, subspecialty urologists are more likely to confront such pelvic floor disorders in bladder cancer survivors. This review presents the most current information on the treatment of pelvic floor disorders after orthotopic bladder substitution.

Management of Voiding Dysfunction After Female Neobladder Creation

Purpose of ReviewFunctional complications after orthotopic neobladder urinary diversion (ONB), including urinary incontinence and urinary retention, present unique challenges. The purpose of this review is to outline contemporary treatment options for voiding dysfunction after ONB in females.Recent FindingsMeticulous surgical technique in the form of urethral nerve-sparing has been shown to play an important role in maintaining continence, as has sparing the uterus when possible. Data supporting the effectiveness of lifestyle measures, urethral bulking, pubovaginal slings, and transobturator slings in the treatment of urinary incontinence are widely variable and limited to case reports. Urinary retention is still most effectively managed with self-catheterization.SummaryVoiding dysfunction after ONB can be devastating. Recent advances focus on improving surgical techniques to decrease the risk of incontinence and retention, as post-operative management options are limited.