Jill M. Danford M.D.

High, R. A., J. M. Danford, Z. Shi, C. Karmonik, T. J. Kuehl, E. T. Bird and R. Khavari (2020). “Protocol for a multicenter randomized, double blind, controlled pilot trial of higher neural function in overactive bladder patients after anticholinergic, beta-3 adrenergic agonist, or placebo.” Contemp Clin Trials Commun 19: 100621.

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INTRODUCTION: Overactive bladder (OAB) syndrome has a negative impact on quality of life and prevalence increases with advanced age. Anticholinergics (AC) and beta-3 adrenergic agonists (β3a) are commonly prescribed medications for treatment of OAB. AC medication has been associated with dementia in population studies and with cortical atrophy in imaging studies. Higher neural effects of both classes of OAB medications have not been evaluated with functional neuroimaging. Longitudinal clinical assessments of cognition after OAB therapy with AC has produced conflicting results. β3a medication is has not been associated with dementia in clinical studies; however, higher neural effects are unknown.Our multicenter, double blind, randomized, placebo-controlled trial uses functional magnetic resonance imaging (fMRI) and cognitive testing to evaluate the effects of AC and β3a on brain functional connectivity in females with non-neurogenic OAB. METHODS AND ANALYSIS: and analysis: Female patients with OAB symptoms ages 50-90 years old without baseline cognitive impairment, moderate to severe depression or anxiety, neurologic disorders, or significant incomplete bladder emptying are invited to participate. Subjects are randomized to one of three interventions for 29 ± 1 day: AC (Solifenacin succinate, Teva), β3a (Mirabegron, Myrbetriq, Astellas), or placebo. Functional neuroimaging data at baseline and post-intervention will be analyzed accordingly. Clinical cognitive assessments will be compared from baseline to post-intervention. ETHICS: All qualifying patients are properly consented before enrolling in this study that has been approved by the Institutional Review Board of participating institutions.

High, R., K. Thai, H. Virani, T. Kuehl and J. Danford (2020). “Prevalence of Pelvic Floor Disorders in Female CrossFit Athletes.” Female Pelvic Med Reconstr Surg 26(8): 498-502.

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OBJECTIVES: This study aimed to estimate the prevalence of pelvic floor disorders by symptoms in female CrossFit athletes in the United States and characterize subjects reporting pelvic organ prolapse symptoms, urinary incontinence, and fecal incontinence. METHODS: A 27-question anonymous questionnaire was distributed to owners of CrossFit-affiliated gyms. Select questions from validated questionnaires were used to define symptoms. Positive responses with “moderate, or quite a bit” bother defined the presence of urinary incontinence (with stress or urgency). A response of “yes” to “having a bulge or something falling out” defined the presence of pelvic organ prolapse. A response of “yes” to “lose stool beyond your control” questions defined the presence of fecal incontinence. RESULTS: Three hundred fourteen respondents had mean age of 36 ± 10 years and a mean body mass index of 25.2 ± 4 kg/m. Forty-four percent reported ≥1 vaginal delivery. For each workout, respondents reported lifting mean weights of 91 to 217 lb, and 90% reported participation in ≥3 CrossFit workouts per week. Pelvic floor disorder symptoms reported included the following: pelvic organ prolapse, 3.2% (10/314); urinary incontinence, 26.1% (82/314); and fecal incontinence, 6% (19/314). Higher age, parity, and number of vaginal deliveries were associated with urinary incontinence. Higher parity and number of vaginal deliveries were associated with prolapse. Fecal incontinence was not associated with age, body mass index, or obstetric history. CONCLUSION: The prevalence of pelvic floor symptoms in female CrossFit athletes from the general population is likely similar to the general population; however, the prevalence of bothersome urinary incontinence is higher than the general population in women younger than 40 years.

High, R. A., W. Winkelman, J. Panza, D. J. Sanderson, H. Yuen, G. Halder, C. Shaver, E. T. Bird, R. G. Rogers and J. M. Danford (2020). “Sacral neuromodulation for overactive bladder in women: do age and comorbidities make a difference?” Int Urogynecol J Jun 25. [Epub ahead of print.].

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OBJECTIVE: To evaluate if age and comorbidities are associated with progression from trial phase to implantation of an implantable pulse generator in women with overactive bladder. METHODS: This multisite retrospective cohort included women with overactive bladder with or without urinary incontinence who had a trial phase for sacral neuromodulation. The primary outcome was progression to implantation. A sub-analysis of implanted patients was performed for the outcome of additional therapies or “implant only” for the duration of follow-up. Multivariate logistic regression models including potential predictors of implantation and post-implantation addition of therapies were performed. RESULTS: At six academic institutions, 91% (785/864) of patients progressed to implantation. Post-implantation success was achieved by 69% (536/782) of patients at median follow-up of 2 (range 0.3 to 15) years. Odds of implantation [OR 0.73 (CI 0.61, 0.88)] and post-implantation success [OR 0.78 (CI 0.98, 0.97)] were lower with increasing decades of age. Medical comorbidities evaluated did not affect implantation rates or post-implant success. CONCLUSIONS: Most women have successful sacral neuromodulation trials despite older age and comorbidities. Higher decade of age has a negative effect on odds of implantation and is associated with addition of therapies post-implantation. Comorbidities assessed in this study did not affect implantation or addition of therapies post-implantation. Most women add therapies to improve efficacy post-implantation, and explantation rates are low.

High, R., Y. Zhang, S. Virani, K. Eggleston, T. J. Kuehl, E. T. Bird and J. M. Danford (2020). “Pilot Trial of Midstream Urine Collection Device Versus Transurethral Catheter in Women With Lower Urinary Tract Symptoms: Practicality of Use in a Clinical Setting, Patient Preferences, and Comparison of Laboratory Findings.” Female Pelvic Med Reconstr Surg Apr 6. [Epub ahead of print].

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OBJECTIVES: This study aimed to evaluate successful use of a midstream urine collection device in women with lower urinary tract symptoms and to assess specimen contamination. METHODS: Nonpregnant women 18 years or older without use of antibiotics in the last 4 weeks were recruited. After using the midstream urine collection device to obtain a specimen in a private restroom, a paired specimen was obtained by transurethral catheterization. Patients completed preference questionnaires. Culture organisms and microscopic urinalysis of paired specimens (device vs catheterized) were compared using the McNemar chi test. Bivariate analysis was performed. RESULTS: Successful use was demonstrated in 54 (77%) of 70. Reasons for failure included inadequate specimen volume and improper device use. Older median age (50 vs 72 years, P = 0.0003) and history of diabetes (7% vs 27%, P = 0.037) were associated with failed use. Organisms were discordant in 21 (41%) of 51 paired urine culture specimens. The device detected 7 (88%) of 8 uropathogens. There were no detectable differences in microscopic urinalysis. CONCLUSIONS: The midstream urine collection device could increase comfort, and many patients prefer it to transurethral catheterization. With proper patient selection and instructions for use, this device could increase satisfaction. Further studies are needed to assess contamination rates with this device.