INTRODUCTION AND HYPOTHESIS:The primary aim of this study was to compare the effect of bladder instillations using dimethyl sulfoxide (DMSO) with triamcinolone versus bupivacaine, triamcinolone, and heparin (BTH) in women with newly diagnosed interstitial cystitis/painful bladder syndrome. The primary outcome was improvement in symptoms measured using the O'Leary-Sant Interstitial Cystitis Symptoms Index (ICSI) score. Secondary comparisons included changes in urinary frequency, nocturia, and bladder capacity. MATERIALS AND METHODS:This was a prospective, randomized study. Patients with a recent diagnosis of interstitial cystitis/painful bladder syndrome (IC/PBS) were randomized 1:1 to treatment with either 6 weekly bladder instillations of DMSO with triamcinolone or BTH. During follow-up visits, patients completed the ICSI questionnaire, and bladder capacity was determined through the retrograde filling of the bladder. The χ2 test or Student's t test were used for data analysis. RESULTS:A total of 83 patients were randomized, and final analysis included 70 participants who completed the 6 weekly instillations (42 DMSO, 28 BTH). The groups were similar in baseline demographics and clinical characteristics, except for cystometric maximum capacity (DMSO 338.62± 139.44 mL, BTH 447.43 ± 180.38 mL, p = 0.01). In the DMSO group, 63% of patients had a greater than 29.5% reduction in total ICSI score versus 43% in the BTH group (p = 0.15). Nocturia and pain were significantly reduced in the DMSO group. There was a significant increase from baseline in bladder capacity for both groups. CONCLUSION:In women with newly diagnosed IC/PBS, bladder instillations with DMSO and triamcinolone provide greater improvement in pain and nocturia compared to BTH.

INTRODUCTION AND HYPOTHESIS:The objective of this narrative review is to describe changes in urethral function that occur during a woman's lifetime. Evaluation of urethral function includes measurements of urethral closure pressure, at rest and during stress, leak point pressure, and the detailed study of anatomical and histological changes of the urethral sphincteric mechanism.METHODS:A literature search in MEDLINE, PubMed, and relevant journals from 1960 until 2020 was performed for articles dealing with urethral function and the impact of aging, pregnancy, and childbirth, female hormones, and menopausal transition on the urethral sphincteric mechanism. Longitudinal and cross-sectional epidemiological surveys, studies on histological changes in urethral anatomy during aging, and urodynamic data obtained at different points in a woman's lifetime, during pregnancy, after childbirth, as well as the effects of female hormones on urethral sphincter function are reviewed. Relevant studies presenting objective data are analyzed and briefly summarized.RESULTS AND CONCLUSIONS:The findings lead one to conclude that a constitutional or genetic predisposition, aging, and senescence are the most prominent etiological factors in the development of urinary incontinence and other pelvic floor disorders. Vaginal childbirth dilates and may damage the compressed pelvic supportive tissues and is invariably associated with a decline in urethral sphincter function. Pregnancy, hormonal alterations, menopausal transition, weight gain, and obesity are at best of secondary influence on the pathology of lower urinary tract dysfunction. The decline of circulating estrogens during menopausal transition may play a role in the transition of fibroblasts to cellular senescence.

The aim of the study was to explore psychiatrists’ perspectives on prescribing psychopharmacological treatment for parents with depression. Nine psychiatrists were interviewed about how the patient’s status as a parent influenced their decisions regarding medical treatment, and how they considered parental functioning to be affected by the treatment. The results showed that psychiatrists weighed the advantages of psychopharmacological treatment against its disadvantages, irrespective of whether the patient was a parent or not. Although some were more restrictive when prescribing medication to parents due to sedative effects, few mentioned how emotional blunting caused by antidepressants could affect a parent’s emotional availability. Furthermore, none of the psychiatrists was aware of any specific guidelines related to the treatment of parents with depression. The lack of guidelines regarding prescription decisions when treating parents may result in a wide range of approaches, depending on what each psychiatrist considers to be optimal treatment.

OBJECTIVES To evaluate the safety and efficacy of the eCoin a nickel-sized, primary battery-powered, neuromodulation device for the treatment of urgency urinary incontinence which is implanted in the lower leg in a 20-minute procedure under local anesthesia. A feasibility clinical trial was conducted and the results after 1 year of treatment with the eCoin are presented. METHODS A total of 46 participants with refractory urgency urinary incontinence were included in this prospective, single-arm, open-label study. This study was conducted at 7 sites in the United States and New Zealand. Participants in this study were implanted with the eCoin in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6, and 12 months' post-activation, were compared to baseline values. RESULTS Responders were defined as those who had a >= 50% reduction in reported episodes of urgency urinary incontinence. At 12 months', 65% of participants were considered responders with 26% of participants achieving complete continence. The median number of urgency urinary incontinence episodes per day decreased from 4.2 at baseline to 1.7 at 12 months'. Seventy percent of participants reported feeling "better", "much better", or "very much better" on the Likert 7-point maximum scale. One participant experienced a related serious adverse event. CONCLUSION The eCoin is a safe and effective treatment for urgency urinary incontinence associated with overactive bladder syndrome, with significant reduction or complete resolution of symptoms and no significant safety concerns

The objective was to find an alternative treatment to a low-dose antibiotic for the prevention of recurrent urinary tract infections (UTI) and to evaluate the difference in rates of reinfection within 1 year when treated with methenamine hippurate for prophylaxis compared with trimethoprim. We present a non-blinded randomized trial comparing methenamine hippurate with trimethoprim for the prevention of recurrent UTI at 12 months after starting treatment. Women over 18 who had at least two culture-positive UTI in the prior 6 months or three in the prior year were included. Ninety-two patients met enrollment criteria and were randomized to receive daily prophylaxis with methenamine hippurate or trimethoprim for a minimum of 6 months. Both intent-to-treat and per-protocol analyses if patients received the alternative drug after randomization were analyzed using Student’s t test, Mann–Whitney U test, Kaplan–Meier curves, log-rank test, and a logistic and multivariate regression model. The primary outcome of this study was culture-proven UTI recurrence by 12 months after initiating prophylaxis. In the intent-to-treat analysis, we found no difference between groups in recurrent UTI, with a 65% (28 out of 43) recurrence in the trimethoprim group versus 65% (28 out of 43) in the methenamine hippurate group (p = 1.00). In the per-protocol analysis, 65% (26 out of 40) versus 65% (30 out of 46) of patients had UTI recurrences in the trimethoprim group versus the methenamine hippurate group (p = 0.98). Methenamine hippurate may be an alternative for the prevention of recurrent UTI, with similar rates of recurrence and adverse effects to trimethoprim.

BackgroundA substantial number of parents receive pharmacological treatment for depression. Pharmacological treatment is known to reduce symptoms, but has also various side effects.AimThe present study aimed to explore possible adverse effects of pharmacological treatment for depression on parental functioning.MethodSix mothers and four fathers, diagnosed with depression, of children younger than 13 years were recruited via outpatient psychiatric clinics. Data was collected through individual semi-structured interviews and analyzed using thematic analysis.ResultsParents described how anxiety suppressants made them fatigued and drowsy which diminished their attention and ability to focus on the child. Moreover, antidepressants and anxiety suppressants were described to cause fatigue, emotional blunting, and restlessness, which made play and stimulation difficult. Emotional blunting, in turn, affected the parents' sense of commitment, empathy, and love for the child. Finally, parents raised concerns about child safety as hypnotics and anxiety suppressants made them unable to wake up at night.ConclusionsConsidering the substantial adverse effects described, parents of minor aged children within psychiatric care needs to be identified in order to offer systematic follow-ups of the effects of pharmacological treatment on parental functioning, and to make adjustments that are feasible from a parent and child perspective.

INTRODUCTION AND OBJECTIVE: Existing options for refractory overactive bladder (OAB) treatment lack appeal to most patients given invasiveness or delivery of therapy, or require significant patient compliance and burden on the provider. A novel, subcutaneously implanted tibial neurostimulator (eCoin) has the potential to address such drawbacks while providing a significant clinical benefit. Presented are interim results from the eCoin-2 pivotal trial, a prospective, multi-center single-arm study evaluating the safety and efficacy of eCoin in treating urgency urinary incontinence (UUI) after 24 weeks. METHODS: At 15 U.S. sites, 133 subjects were implanted with eCoin in the medial lower leg during an office procedure under local anesthesia. We included men and women ages 18-80 with at least one daily UUI episode on a 3-day voiding diary. Subjects were washed off OAB medications prior to baseline. The leadless, primary battery-powered eCoin device is slightly larger than a U.S. nickel and delivers automated therapy every 3-4 days for 30 minutes. The primary efficacy variable is the proportion of subjects achieving ≥50% improvement in UUI episodes (responder rate) after 48 weeks of therapy. Secondary outcomes included 3-day voiding diary data and patient reported outcomes. Paired t-tests were used to compare continuous variables between baseline and 24 weeks with differences reported with 95% confidence intervals. RESULTS: At baseline in all subjects, average age (SD) was 64 (11), BMI was 30.4 (8.8), daily UUI episodes was 4.2 (3.1), and the OABq-SF symptom bother score was 65.7 (20.0). 98.5% of subjects were female. The average procedure time was 20.8 minutes. There was one related serious adverse event, a localized infection resolved by device explant. In 113 subjects available at 24 weeks, all measures showed statistically significant improvement: UUI leaks were reduced by -2.7 (p<0.001, 95%CI (-3.2,-2.1)) and the symptom bother score was improved by 32.6 (p<0.001, 95%CI (-37.6, -27.6)). The responder rate was 70.8%, and 77.8% of patients reported feeling at least better on the PGI-I. In patients with ≥10 daily voids at baseline (n=58), frequency improved by -1.9 (p<0.001, (-2.6, -1.1)) from 12.7 mean voids. CONCLUSIONS: The interim data demonstrates that eCoin is safe and effective in treating UUI, delivering meaningful symptom improvement with minimal invasiveness. The eCoin procedure also appears to have a short learning curve and is an easy to perform office-based procedure. Source of Funding: Research was funded by Valencia Technologies.

The objective of our study is to compare patient self-reported urinary incontinence symptoms based on the International Consultation on Incontinence Questionnaire- Short Form (ICIQ-SF) question number 6 (When does urine leak?) with physician-assessed interpretation of the patient’s urinary incontinence symptoms. This trial is a cross-sectional study of patients who presented to a tertiary urogynecology center with symptoms of urinary incontinence between January 2014 and August 2016. We compared patient-reported symptoms on the ICIQ-SF with physician interpretation of urinary complaints during their initial visit. The urinary incontinence symptoms included stress urinary incontinence (SUI), urgency urinary incontinence (UUI), insensible urine loss, nocturnal enuresis, and post-micturition dribbling. A total of 432 patients with a mean age of 61 were included in this evaluation. The most common urinary incontinence symptoms according to the physician were UUI (n = 357, 83%), followed by SUI (n = 308, 71%). Of the patients who were diagnosed by a physician with the symptom of UUI, only 61% self-identified as having this symptom based on the ICIQ-SF, and for SUI, only 66% self-identified as having SUI symptoms based on the ICIQ-SF. Overall UUI (κ = 0.30) appears to have poor agreement, as does nocturnal enuresis (κ = 0.39), when compared with physician historical assessment. There is a discrepancy between patient-reported urinary incontinence symptoms on the ICIQ-SF and physician-assessed symptoms. Symptomatology entered into electronic medical records by patients is often inaccurate. Physician validation is essential in understanding the underlying the precise symptomatology.

The present study reports a case of a patient with a mid‐urethral sling mesh exposure who developed a vaginal calculus on a portion of exposed mesh.

Nocturia is a bothersome, multifactorial condition with many underlying causes and contributing factors. Nocturnal polyuria (NP; overproduction of urine at night) is a frequent component. The prevalence of nocturia increases with age; specific estimates of prevalence are influenced by frequency thresholds used to define it. There is a tendency toward higher prevalence in young women than young men, which is reversed in later life.The association between frequency of nocturnal voiding and sleep disruption is well-documented. Nocturia correlates strongly with shorter sleep during the first part (2-4 hours) of the night, during which the first nocturnal void often occurs. A short time to first void after sleep onset (often referred to as "first uninterrupted sleep period") is associated with increased daytime dysfunction and decreased sleep quality and/or sleep efficiency.Adverse health consequences related to nocturia include poor sleep, depression, reduced quality of life, and increased risk of morbidity, mortality, falls, and fractures; studies have been able to establish a causal role for nocturia in only some of these.The potential impact of nocturia on health increases with age. By age 80, 80% of people will rise at least once per night to void. Despite its associated bother, nocturia is often accepted as a natural consequence of aging and many people do not seek help. Women, in particular, may be reluctant to report nocturia.This article reviews the prevalence of nocturia, possible impact on sleep, mortality and morbidity, and falls, and its importance in the elderly/frail population and women.

You have accessJournal of UrologySunday Next Frontier (LBA)1 Apr 2019LBA-06 12 MONTH FEASIBILITY DATA OF A FULLY-IMPLANTED, NICKEL-SIZED AND SHAPED TIBIAL NERVE STIMULATOR FOR THE TREATMENT OF OVERACTIVE BLADDER SYNDROME WITH URGENCY URINARY INCONTINENCE Scott MacDiarmid*, Vincent Lucente, Bilal Kaaki, Sharon English, Peter Gilling, Patrick Meffan, Matthew Clark, Peter Sand, Subhro Sen, and Eric Rovner Scott MacDiarmid*Scott MacDiarmid* More articles by this author , Vincent LucenteVincent Lucente More articles by this author , Bilal KaakiBilal Kaaki More articles by this author , Sharon EnglishSharon English More articles by this author , Peter GillingPeter Gilling More articles by this author , Patrick MeffanPatrick Meffan More articles by this author , Matthew ClarkMatthew Clark More articles by this author , Peter SandPeter Sand More articles by this author , Subhro SenSubhro Sen More articles by this author , and Eric RovnerEric Rovner More articles by this author View All Author Informationhttps://doi.org/10.1097/01.JU.0000557498.26013.2eAboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookLinked InTwitterEmail Abstract INTRODUCTION AND OBJECTIVES: The eCoin® (Electroceutical Coin) (Valencia Technologies Corp., Valencia, CA, USA) is an investigational, implanted, battery-powered, slightly larger than a United States nickel in diameter (23.3 mm versus 21.2 mm) and thickness (2.4 mm versus 1.95 mm), neuromodulation device for the treatment of overactive bladder syndrome (OAB) with urgency urinary incontinence (UUI) in adults who have an inadequate response to or are intolerant of OAB medications by electrically stimulating the tibial nerve. The device can be implanted during an office-based procedure under local anesthesia, and does not require external stimulation. This was a 12 month clinical feasibility trial to evaluate the long-term safety and efficacy of eCoin® tibial nerve stimulation to treat refractory UUI. METHODS: The long-term (12 month) study was a prospective, single-arm, open-label study including 46 participants with refractory UUI, conducted at multiple sites in the US and New Zealand. The eCoin® was implanted in the lower leg over the tibial nerve and activated after 4 weeks. Bladder diary data and validated quality-of-life instruments, collected at 3, 6 and 12 months post-activation, were compared to baseline. RESULTS: Mean age was 63.4 ± 11.5 years and 45 participants were female. Episodes of UUI were reduced by a median 68% after 12 months of treatment (4.2 versus 1.7 episodes/day at 12 months; p=.001). Overall, 30/46 participants (65%) experienced more than a 50% improvement in UUI. Of those participants, 8 experienced ≥ 75% improvement and 12 experienced 100% improvement. Incontinence quality of life (I-QOL) scores improved by a mean of 86%. A single serious adverse event, secondary to the provided ankle wrap, resolved with intravenous antibiotics. CONCLUSIONS: The implantable eCoin® neuromodulation device showed durable efficacy and safety through 12 months and is a promising new treatment option for refractory OAB. Source of Funding: Valencia Technologies Corp. Greensboro, NC; Allentown, PA; Waterloo, IA; Christchurch, New Zealand; Tauranga, New Zealand; Nelson, New Zealand; Newport Beach, CA; Skokie, IL; Redwood City, CA; Charleston, SC© 2019 by American Urological Association Education and Research, Inc.FiguresReferencesRelatedDetails Volume 201Issue Supplement 4April 2019Page: e994-e994 Advertisement Copyright & Permissions© 2019 by American Urological Association Education and Research, Inc.MetricsAuthor Information Scott MacDiarmid* More articles by this author Vincent Lucente More articles by this author Bilal Kaaki More articles by this author Sharon English More articles by this author Peter Gilling More articles by this author Patrick Meffan More articles by this author Matthew Clark More articles by this author Peter Sand More articles by this author Subhro Sen More articles by this author Eric Rovner More articles by this author Expand All Advertisement PDF downloadLoading ...

Introduction and hypothesis To assess cognitive changes in women 12 months after starting anticholinergic medications for overactive bladder syndrome (OAB). Methods We present a prospective cohort study assessing changes in cognition in women seen in a referral urogynecology practice. We compared women who started anticholinergic OAB medications with women not on anticholinergic OAB medications. The primary outcome was change over time on the Montreal Cognitive Assessment (MOCA) screening score. At enrollment, women completed a baseline MOCA screening, a Geriatric Depression Screen (GDS), and an assessment of medications to create an anticholinergic burden score (ACB). At 3, 6, 9, and 12 months after enrollment women were administered the MOCA, GDS, and a review of their medications and medical problems. Statistical analysis was performed using a linear mixed effects model taking into account correlated error terms given multiple MOCA assessments at various time points per patient. Results A total of 106 women were enrolled, 60 in the OAB medication group and 46 in the control (non-OAB medication) group. The mean age was 77 years, 93% of women were Caucasian, and 98% completed high school, with no difference between groups. Over time there was no difference in change of MOCA score between the OAB and control groups when controlling for age, GDS score, and ACB score (p = 0.78). This association did not change when women with a neurological diagnosis were excluded (n = 6). On average MOCA scores for the OAB group increased by 0.76 over 12 months and the control group increased 0.39, with no difference between the groups (p = 0.53). Conclusions We found no changes in MOCA scores between OAB medication and control groups after controlling for age, depression, and polypharmacy after 12 months of follow-up.

Objective The objective of this study was to determine whether anterior colporrhaphy plus insertion of anterior dermal allograft reduces anterior prolapse recurrence at 1 and 7 to 10 years postoperatively compared with anterior colporrhaphy alone. Methods We present a nonblinded randomized controlled trial with 1- and 7- to 10-year follow-up. Subjects were randomized between 2005 and 2008 to anterior colporrhaphy or ultralateral anterior colporrhaphy plus insertion of a dermal allograft spanning the anterior compartment between the arcus tendineus fascia pelvis on each side. Eligible subjects had anterior prolapse to the hymen or beyond, were bothered by their prolapse, and were planning to undergo surgical correction. Subjects completed a pelvic organ prolapse quantification system (POPQ) examination and Pelvic Floor Distress Inventory (PFDI)/PFDI-20 before surgery; a POPQ, PFDI, and Pelvic Organ Prolapse/Incontinence Sexual Questionnaire at 1 year postoperatively; and a POPQ, PFDI-20, Pelvic Organ Prolapse/Incontinence Sexual Questionnaire, Revised, and Patient-reported Global Impression of Improvement Inventory at 7 to 10 years postoperatively. Our primary outcome was anatomic anterior prolapse recurrence at 1 or 7 to 10 years defined as Aa or Ba greater than or equal to −1. Our secondary outcome was a composite score of anterior prolapse recurrence at 1 or 7 to 10 years defined as anatomic recurrence (Aa or Ba ≥ 0), retreatment for cystocele, or answering yes to PFDI-20 question 3 (subjective report of vaginal bulge). Results A total of 114 subjects were randomized, 70 to anterior colporrhaphy and 44 to anterior colporrhaphy plus dermal allograft. About 92% of subjects underwent concomitant apical suspension, 98% in the graft group and 89% in the nongraft group. Eighty-nine subjects (32 graft [73%], 57 nongraft [81%]) returned for 1-year follow-up. Fifty-three patients (19 graft [48%], 34 nongraft [49%]) returned for 7- to 10-year follow-up. The primary outcome was met by 8 (18%) graft and 22 (31%) nongraft subjects at 1 year postoperatively ( P = 0.26) and by 10 (23%) graft and 24 (34%) nongraft subjects at 7 to 10 years postoperatively ( P = 0.37). The secondary outcome was met by 8 (18%) graft and 15 (21%) nongraft subjects at 1 year postoperatively ( P = 0.74) and by 13 (30%) graft and 21 (30.0%) nongraft subjects at 7 to 10 years postoperatively ( P = 0.99). Conclusions We cannot conclude whether there is a difference in anterior recurrence for anterior colporrhaphy with and without dermal allograft and do not recommend changes in clinical practice based on these results.

The objective of this narrative review is to study the impact of pregnancy and childbirth on pelvic floor function as assessed by objective measurement techniques with quantitative data carried out during pregnancy and after childbirth. A literature search in MEDLINE and relevant and up-to-date journals from 1960 until April 2017 was performed for articles dealing with the impact of pregnancy and childbirth on pelvic floor function as assessed by objective measurement methods. Only studies describing objective measurement techniques. i.e., urodynamics, ultrasound (US), magnetic resonance imaging (MRI), Pelvic Organ Prolapse Quantification (POP-Q) system, and neurophysiologic tests carried out throughout pregnancy and after childbirth are included. Relevant studies presenting objective quantitative data are analyzed and briefly summarized. The number of studies meeting selection criteria was relatively few. Pregnancy, especially first pregnancy, is associated bladder neck lowering, increased bladder neck mobility, pelvic organ descent, decreased levator ani strength, and decreased urethral resistance. These changes are accentuated after vaginal delivery. Data on the impact of obstetrical and neonatal variables are transient and seem of less importance. Cesarean delivery is not completely protective. In most women, pelvic floor muscle function recovers in the year after delivery. Objective measurement techniques during pregnancy may allow identification of women susceptible to pelvic floor dysfunction later in life and offer the opportunity for counseling and preventive treatment strategies.