A prospective assessment of the validity of the CUA neurogenic bladder guideline.

INTRODUCTION: The Canadian Urological Association (CUA) neurogenic bladder guideline surveillance strategy for neurogenic lower urinary tract dysfunction (NLUTD) has not been formally evaluated. Our objective was to evaluate the validity of the risk stratification suggested in these guidelines. METHODS: This was a prospective, observational cohort study of adult NLUTD patients with spinal cord injury, multiple sclerosis, or spina bifida who required urodynamics. Patients with a requirement for immediate bladder surgery (not suitable for surveillance) were excluded. Patients completed standardized medical history/questionnaires, baseline urodynamics, renal imaging, and creatinine tests. The primary outcome was the need for different types of urological management between the high-risk and moderate-risk groups. RESULTS: We enrolled 68 patients; most commonly, these were spinal cord injury patients, and most people were using intermittent catheters. At baseline, 62% (40/68) were classified as high-risk. In this group, there was a numerically greater proportion who received a recommendation for a new urological medication (48% vs. 25%, p=0.06) or a change to their bladder management (45% vs. 36%, p=0.44). A total of 26 high-risk and 23 medium-risk NLUTD patients had a one- year followup visit. A larger proportion of the high-risk patients had a recommendation for a new bladder medication (15.4% vs. 8.7% p=0.47), intravesical onabotulinum toxin (34.6% vs. 13% p=0.08), or an alternate method of bladder management (15.4% vs. 4.3%, p=0.2). Mean creatinine change was slightly greater in the high-risk group (+6.1 vs. +0.4 umol/L, p=0.05). Approximately 1/3 of both high-risk and moderate-risk patients didn't accept the recommended interventions. CONCLUSIONS: A higher proportion of high-risk NLUTD patients had urology-relevant interventions recommended, both at baseline and at their one-year followup visit. This supports the general concept of risk stratification and the variables used to define high-risk in the CUA's neurogenic bladder guideline.

Using conjoint analysis to measure the importance of psychosocial traits in the choices of bladder management after spinal cord injury.

OBJECTIVE: To conduct a conjoint analysis experiment to better understand the psychosocial priorities related to bladder management in individuals after spinal cord injury (SCI). METHODS: We developed a conjoint analysis survey that included 11 psychosocial attributes phrased in the context of bladder management (including attributes for urinary infections, and incontinence). We then performed a multi-center prospective cross-sectional study of adults with existing SCI which consisted of a baseline interview, followed by the online conjoint analysis survey (delivered through Sawtooth software). Hierarchical Bayes random effects regression analysis was used to determine the relative importance of the attributes. RESULTS: A total of 345 people complete the study. There was good representation of both men and women, and individuals with cervical and thoracic or lower lesions. The most important attribute was the frequency of urinary infections. Age, sex, and level of SCI were generally not related to the attributes measured in the study. In the subgroup of 256 patients who used a catheter for bladder management, significantly more importance was placed on urinary tract infections, time, fluid intake, and social life among indwelling catheter users compared to intermittent catheter users. CONCLUSIONS: Most bladder-related psychosocial priorities are not impacted by a patient's age, sex or level of SCI. Differences in psychosocial priorities between indwelling and intermittent catheter users may represent factors that should be focused on to optimize bladder management after SCI.

A qualitative assessment of psychosocial aspects that play a role in bladder management after spinal cord injury.

STUDY DESIGN: Prospective qualitative study using semi-structured, open-ended interviews. OBJECTIVES: To better understand psychosocial aspects of bladder management after spinal cord injury (SCI). SETTING: People with SCI, recruited through three tertiary care centres in North America. METHODS: Thirty-four community-dwelling individuals with SCI were selected using purposive sampling to ensure men and women with both tetraplegia and paraplegia were represented. The interviews were audio recorded and transcribed. NVivo software was used to code psychosocial domains, medical complications, and methods of bladder management. A qualitative interpretive approach was used, and four participants participated in a debrief session to review the study findings. RESULTS: The median age was 49 (IQR 40-62) years and 61% (21/34) were male. Most had complete injuries (AIS A, 47%, 16/34), and most had a cervical lesion (56%, 19/34). There was a large range of time living with a SCI (median 20 years, IQR 9-31), and most participants managed their bladder with intermittent catheterisation (67% 23/34). The five most common psychosocial domains were anxiety (often in the context of urinary infections, incontinence, or not being able to catheterise), loss of control (due to irregular bladder behaviour), and embarrassment (from incontinence occurring in public); the domains of confidence and independence/planning included both positive and negative examples of bladder management experiences. CONCLUSIONS: This study demonstrated consistent psychosocial topics related to bladder management in people living with SCI. This information will help counsel people regarding bladder management and identify areas for education and optimisation of bladder function from a psychosocial perspective.

A randomized, controlled trial of transcutaneous tibial nerve stimulation to treat overactive bladder and neurogenic bladder patients.

INTRODUCTION: We aimed to determine if transcutaneous tibial nerve stimulation (TTNS) is effective at treating overactive bladder (OAB) symptoms among neurogenic and non-neurogenic patients. METHODS: We conducted a randomized, double-blind, sham-controlled study. Adult patients were recruited from one of two groups: 1) women with OAB; and 2) patients with neurogenic disease and bladder symptoms. The intervention was stimulation of the posterior tibial nerve, for 30 minutes, three times per week for 12 weeks at home using transcutaneous patch electrodes. The primary outcome was improvement of the patient perception of bladder condition (PPBC). We used ANCOVA (with adjustment for baseline values) and followed the intention-to-treat principle; we reported marginal means (MM) and a p<0.05 was considered significant. RESULTS: We recruited 50 patients (OAB n=20, neurogenic bladder n=30); 24 were allocated to the sham group and 26 to the active TTNS group. Baseline characteristics in both groups were similar. At the end of the study, there was no significant difference in the PPBC between sham or active groups: 13% (3/24) of sham patients and 15% (4/26) of active TTNS patients were responders (p=0.77), and the MM of the end-of-study PPBC score was 3.3 (95% confidence interval [CI] 2.8-3.7) vs. 2.9 (95% CI 2.5-3.4), respectively (p=0.30). Similarly, there were no significant differences in secondary outcomes (24-hour pad weight, voiding diary parameters, or condition-specific patient-reported outcomes). The results were similar within the OAB and neurogenic bladder subgroups. CONCLUSIONS: TTNS does not appear to be effective for treating urinary symptoms of people with OAB or neurogenic bladder dysfunction.

A pilot randomized-controlled trial of the urodynamic efficacy of mirabegron for patients with neurogenic lower urinary tract dysfunction.

AIMS: To determine the effectiveness of mirabegron in patients with neurogenic lower urinary tract dysfunction. METHODS: Randomized, double-blind, placebo-controlled study. Canadian patients with spinal cord injury (SCI) or multiple sclerosis (MS) with urinary symptoms and incontinence were recruited. Patients were randomized to mirabegron 25 mg (or an identical placebo) for 2 weeks at which point a dose escalation to mirabegron 50 mg (or an identical placebo) was maintained for 8 weeks. Urodynamics were performed before and after treatment. The primary outcome measure was maximum cystometric capacity (MCC). Intention to treat analysis and ANCOVA models (with adjustment for baseline values) were used and marginal means (MM) are reported; P-value <0.05 was considered significant. RESULTS: Sixteen (9 SCI and 7 MS) patients were randomized to mirabegron and 16 (10 SCI and 6 MS) to placebo. At study completion, there was no significant difference in MCC between mirabegron and placebo (MM 305 vs 369 mL, P = 0.20). There was no significant difference in volume at first neurogenic detrusor overactivity (NDO, MM 167 vs 137 mL, P = 0.14) and peak pressure of NDO (MM 69 vs 82 cmH2 O, P = 0.25). There was no significant difference in pad weights or voiding diary parameters. There was a significantly lower symptom burden among those treated with mirabegron (total neurogenic bladder symptom score MM 29 vs 34, P = 0.047). CONCLUSIONS: Among patients with SCI or MS, we demonstrated non-significant trends towards improvement in some urodynamic parameters with mirabegron 50 mg compared to placebo, and a significantly lower neurogenic bladder symptom burden.