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Re: Efficacy of Oral Extended-Release Oxybutynin in Cognitively Impaired Older Nursing Home Residents with Urge Urinary Incontinence: A Randomized Placebo-Controlled Trial
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GERIATRICS
Editorial Comment: Falls are common in older adults and may be associated with a risk of significant injury, including long bone and hip fractures. A number of studies have previously demonstrated that urinary incontinence is associated with an increased risk of falls in older adults. However, most studies either have focused on general definitions of urinary incontinence or have specifically examined urinary urgency, frequency and urge urinary incontinence. This study is unique in that it is the first to document a relationship between stress urinary incontinence and an increased risk of falls in community dwelling elderly people. Individuals who fell were nearly twice as likely to have stress incontinence (23.4%) compared to nonfallers (12.8%, p<0.0001). The relationship between urge urinary incontinence and falls was again confirmed. Mobility limitations and changes in gait and balance are also important risk factors confirmed in this study. Additional research will be needed to document that treatments to improve stress incontinence and other forms of voiding dysfunction may decrease fall risk in older, community dwelling adults. Tomas L. Griebling, M.D., M.P.H.
Re: Efficacy of Oral Extended-Release Oxybutynin in Cognitively Impaired Older Nursing Home Residents with Urge Urinary Incontinence: A Randomized Placebo-Controlled Trial T. E. Lackner, J. F. Wyman, T. C. McCarthy, M. Monigold and C. Davey Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota J Am Med Dir Assoc 2011; 12: 639 – 647.
Objectives: To determine the efficacy of oral extended-release oxybutynin for urge urinary incontinence in older female nursing home residents with mild to severe cognitive impairment. Design: Randomized, double-blind, placebo-controlled trial. Setting: Twelve skilled nursing homes. Participants: Fifty women aged 65 and older with urge incontinence and cognitive impairment. Intervention: Four-week treatment with daily oral extended-release oxybutynin 5 mg or placebo. Measurements: Urinary incontinence episodes, urinary frequency, and total dryness assessed hourly over two 8-hour days (8 AM TO 4 PM), and evening and night nursing staff ratings of urinary symptoms. Results: Of the participants, 96% (n ⫽ 25) on oxybutynin and 92% (n ⫽ 22) on placebo completed the trial. Compared with baseline, both groups achieved a significant median decrease in mean urinary incontinence episodes and urinary frequency at 4 weeks (P ⫽ .01–.05). There were no significant between-group differences in any urological outcome. In the exploratory analysis, there were no significant differences from baseline or placebo in any urological outcome with oxybutynin in participants with mild to moderate cognitive impairment and/or adequate mobility compared with participants with more severe cognitive and physical impairment. Staff ratings found that more participants had improvement in urinary symptoms from baseline with oxybutynin than placebo but significant only for delaying evening voiding (P ⫽ .02). Conclusion: Extended-release oxybutynin 5 mg per day for 4 weeks in older cognitively impaired female nursing home residents did not significantly reduce urinary incontinence and urinary frequency or achieve dryness. Participants with mild to moderate cognitive and/or physical impairment were no more likely to benefit from oxybutynin than more severely impaired individuals in an exploratory analysis but further research in a larger population and perhaps using a larger dose is needed. Editorial Comment: Urinary incontinence (UI) is highly prevalent in nursing home residents. Although antimuscarinic medications are a mainstay of treatment for urinary urgency and urge UI, there may be concern about using these medications in this more vulnerable population, since many of these patients also suffer from some degree of cognitive impairment. This is the first published study to examine the use of this class of medications in a cognitively impaired nursing home cohort that was not also undergoing some form of behavioral therapy or toileting program. Although the number of wet pad checks decreased by 38% in those receiving extended release oxybutynin in this study, the median percent change from baseline was not significantly different from the placebo
GERIATRICS
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group. Overall there was no significant benefit for UI outcomes in this particular population at a low, fixed dose of medication. These findings highlight many of the challenges in providing UI care in this vulnerable patient population. The authors note that different results might be obtained using increased doses of medication, and they encourage future research to examine this topic. Tomas L. Griebling, M.D., M.P.H.
Re: Tai Chi for Lower Urinary Tract Symptoms and Quality of Life in Elderly Patients with Benign Prostate Hypertrophy: A Randomized Controlled Trial S. Jung, E.-N. Lee, S.-R. Lee, M.-S. Kim and M. S. Lee Department of Urology, College of Medicine, Dong-A University, Busan, Republic of Korea Evid Based Complement Alternat Med 2012; 2012: 624692.
Tai chi exercise has been recommended as suitable for the improvement of health in the elderly. The purpose of this study was to investigate the effects of tai chi on lower urinary tract symptoms (LUTSs), quality of life (QoL), and sex hormone levels in patients with benign prostate hypertrophy (BPH). The elderly patients with BPH were randomized to receive tai chi or usual care. Fifty-six participants were randomized into either the tai chi group (n ⫽ 28) or the control group (n ⫽ 28). After 12 weeks of treatment, the tai chi group showed significant improvement in LUTS and QoL. There was a significant effect of tai chi on testosterone but no significant effect on insulin or glucose. No serious adverse events were observed during the study period. In conclusion, our results suggest that 12 weeks of tai chi may improve LUTS and QoL in elderly patients with BPH. Editorial Comment: The popularity of tai chi in older adults has increased exponentially in recent years. Many studies in the geriatric literature have examined this activity regarding potential improvements in gait and balance, decreased risk of falls and fractures, improved cardiopulmonary function, increased muscle strength, and improved social interaction and mood. The authors of this unique pilot study hypothesized that tai chi might have benefits for older men with BPH and LUTS through modulation of the autonomic nervous system. Urinary symptoms and QoL parameters were assessed using validated instruments, including the International Prostate Symptom Score. Biochemical markers including testosterone and insulin resistance were also assessed. The tai chi activity was standardized and consisted of a warm-up exercise (15 minutes), 11 basic and 9 combined movements (40 minutes), and a cooldown exercise (5 minutes). Instruction in focused breathing was also part of the training. Participants in the treatment group did the tai chi exercises 3 times weekly for 12 weeks (36 sessions). The study showed a statistically significant improvement in mean voiding symptoms measured by the International Prostate Symptom Score for men who did tai chi (13.07 at baseline, 8.93 after treatment) compared to controls (16.36 at baseline, 17.07 after treatment, p ⴝ 0.03). Degree of worry and concern, interference with daily activities and serum testosterone also improved significantly in men randomized to the tai chi group compared to controls. The results must be interpreted cautiously due to several study limitations, including the small sample size, a dropout rate of 50% in the treatment and control groups, and followup of only 12 weeks. However, the observed results are intriguing and would support consideration of larger well designed trials to examine the potential benefits of this form of exercise in elderly men with BPH and LUTS. Tomas L. Griebling, M.D., M.P.H.
GERIATRICS
Editorial Comment: Falls are common in older adults and may be associated with a risk of significant injury, including long bone and hip fractures. A number of studies have previously demonstrated that urinary incontinence is associated with an increased risk of falls in older adults. However, most studies either have focused on general definitions of urinary incontinence or have specifically examined urinary urgency, frequency and urge urinary incontinence. This study is unique in that it is the first to document a relationship between stress urinary incontinence and an increased risk of falls in community dwelling elderly people. Individuals who fell were nearly twice as likely to have stress incontinence (23.4%) compared to nonfallers (12.8%, p<0.0001). The relationship between urge urinary incontinence and falls was again confirmed. Mobility limitations and changes in gait and balance are also important risk factors confirmed in this study. Additional research will be needed to document that treatments to improve stress incontinence and other forms of voiding dysfunction may decrease fall risk in older, community dwelling adults. Tomas L. Griebling, M.D., M.P.H.
Re: Efficacy of Oral Extended-Release Oxybutynin in Cognitively Impaired Older Nursing Home Residents with Urge Urinary Incontinence: A Randomized Placebo-Controlled Trial T. E. Lackner, J. F. Wyman, T. C. McCarthy, M. Monigold and C. Davey Department of Experimental and Clinical Pharmacology, College of Pharmacy, University of Minnesota, Minneapolis, Minnesota J Am Med Dir Assoc 2011; 12: 639 – 647.
Objectives: To determine the efficacy of oral extended-release oxybutynin for urge urinary incontinence in older female nursing home residents with mild to severe cognitive impairment. Design: Randomized, double-blind, placebo-controlled trial. Setting: Twelve skilled nursing homes. Participants: Fifty women aged 65 and older with urge incontinence and cognitive impairment. Intervention: Four-week treatment with daily oral extended-release oxybutynin 5 mg or placebo. Measurements: Urinary incontinence episodes, urinary frequency, and total dryness assessed hourly over two 8-hour days (8 AM TO 4 PM), and evening and night nursing staff ratings of urinary symptoms. Results: Of the participants, 96% (n ⫽ 25) on oxybutynin and 92% (n ⫽ 22) on placebo completed the trial. Compared with baseline, both groups achieved a significant median decrease in mean urinary incontinence episodes and urinary frequency at 4 weeks (P ⫽ .01–.05). There were no significant between-group differences in any urological outcome. In the exploratory analysis, there were no significant differences from baseline or placebo in any urological outcome with oxybutynin in participants with mild to moderate cognitive impairment and/or adequate mobility compared with participants with more severe cognitive and physical impairment. Staff ratings found that more participants had improvement in urinary symptoms from baseline with oxybutynin than placebo but significant only for delaying evening voiding (P ⫽ .02). Conclusion: Extended-release oxybutynin 5 mg per day for 4 weeks in older cognitively impaired female nursing home residents did not significantly reduce urinary incontinence and urinary frequency or achieve dryness. Participants with mild to moderate cognitive and/or physical impairment were no more likely to benefit from oxybutynin than more severely impaired individuals in an exploratory analysis but further research in a larger population and perhaps using a larger dose is needed. Editorial Comment: Urinary incontinence (UI) is highly prevalent in nursing home residents. Although antimuscarinic medications are a mainstay of treatment for urinary urgency and urge UI, there may be concern about using these medications in this more vulnerable population, since many of these patients also suffer from some degree of cognitive impairment. This is the first published study to examine the use of this class of medications in a cognitively impaired nursing home cohort that was not also undergoing some form of behavioral therapy or toileting program. Although the number of wet pad checks decreased by 38% in those receiving extended release oxybutynin in this study, the median percent change from baseline was not significantly different from the placebo
GERIATRICS
227
group. Overall there was no significant benefit for UI outcomes in this particular population at a low, fixed dose of medication. These findings highlight many of the challenges in providing UI care in this vulnerable patient population. The authors note that different results might be obtained using increased doses of medication, and they encourage future research to examine this topic. Tomas L. Griebling, M.D., M.P.H.
Re: Tai Chi for Lower Urinary Tract Symptoms and Quality of Life in Elderly Patients with Benign Prostate Hypertrophy: A Randomized Controlled Trial S. Jung, E.-N. Lee, S.-R. Lee, M.-S. Kim and M. S. Lee Department of Urology, College of Medicine, Dong-A University, Busan, Republic of Korea Evid Based Complement Alternat Med 2012; 2012: 624692.
Tai chi exercise has been recommended as suitable for the improvement of health in the elderly. The purpose of this study was to investigate the effects of tai chi on lower urinary tract symptoms (LUTSs), quality of life (QoL), and sex hormone levels in patients with benign prostate hypertrophy (BPH). The elderly patients with BPH were randomized to receive tai chi or usual care. Fifty-six participants were randomized into either the tai chi group (n ⫽ 28) or the control group (n ⫽ 28). After 12 weeks of treatment, the tai chi group showed significant improvement in LUTS and QoL. There was a significant effect of tai chi on testosterone but no significant effect on insulin or glucose. No serious adverse events were observed during the study period. In conclusion, our results suggest that 12 weeks of tai chi may improve LUTS and QoL in elderly patients with BPH. Editorial Comment: The popularity of tai chi in older adults has increased exponentially in recent years. Many studies in the geriatric literature have examined this activity regarding potential improvements in gait and balance, decreased risk of falls and fractures, improved cardiopulmonary function, increased muscle strength, and improved social interaction and mood. The authors of this unique pilot study hypothesized that tai chi might have benefits for older men with BPH and LUTS through modulation of the autonomic nervous system. Urinary symptoms and QoL parameters were assessed using validated instruments, including the International Prostate Symptom Score. Biochemical markers including testosterone and insulin resistance were also assessed. The tai chi activity was standardized and consisted of a warm-up exercise (15 minutes), 11 basic and 9 combined movements (40 minutes), and a cooldown exercise (5 minutes). Instruction in focused breathing was also part of the training. Participants in the treatment group did the tai chi exercises 3 times weekly for 12 weeks (36 sessions). The study showed a statistically significant improvement in mean voiding symptoms measured by the International Prostate Symptom Score for men who did tai chi (13.07 at baseline, 8.93 after treatment) compared to controls (16.36 at baseline, 17.07 after treatment, p ⴝ 0.03). Degree of worry and concern, interference with daily activities and serum testosterone also improved significantly in men randomized to the tai chi group compared to controls. The results must be interpreted cautiously due to several study limitations, including the small sample size, a dropout rate of 50% in the treatment and control groups, and followup of only 12 weeks. However, the observed results are intriguing and would support consideration of larger well designed trials to examine the potential benefits of this form of exercise in elderly men with BPH and LUTS. Tomas L. Griebling, M.D., M.P.H.