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Socioeconomic Factors, Urological Epidemiology and Practice Patterns
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS Acupuncture for Overactive Bladder: A Randomized Controlled Trial S. L. Emmons and L. Otto, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon Obstet Gynecol, 106: 138 –143, 2005 Objective: To compare acupuncture treatment for overactive bladder with urge incontinence with a placebo acupuncture treatment. Methods: Eighty-five women enrolled in this randomized, placebo-controlled trial. Women were randomly assigned to either receive an acupuncture treatment expected to improve their bladder symptoms, or a placebo acupuncture treatment designed to promote relaxation. They underwent cystometric testing, completed a 3-day voiding diary, and completed the urinary distress inventory and incontinence impact questionnaire, validated quality-of-life inventories, before and after 4 weekly acupuncture treatments. The primary endpoint was number of incontinent episodes over 3 days. Secondary endpoints included voiding frequency and urgency, cystometric bladder capacity, maximum voided volume, and the urinary distress inventory and incontinence impact questionnaire symptom scores. Results: Seventy-four women completed all aspects of the study. Women in both treatment and placebo groups had significant decreases in number of incontinent episodes (59% for treatment, 40% for placebo) without a significant difference in the change between the groups. Women in the treatment group had a 14% reduction in urinary frequency (P ⫽ .013), a 30% reduction in the proportion of voids associated with urgency (P ⫽ .016), and a 13% increase in both maximum voided volume and maximum cystometric capacity (P ⫽ .01). Both groups also had an improvement in the urinary distress inventory and incontinence impact questionnaire scores (54% decrease for treatment, 30% decrease for placebo, P ⬍.001 for the difference in change between the groups). Conclusion: Women who received 4 weekly bladder-specific acupuncture treatments had significant improvements in bladder capacity, urgency, frequency, and quality-of-life scores as compared with women who received placebo acupuncture treatments. Level of Evidence: I. Editorial Comment: One cannot watch the 6 o’clock news without appreciating that overactive bladder is a common medical condition. The most common treatments, anticholinergic medications, have significant side effects and are often only partially effective. Only about 18% of patients are compliant with these drugs after 6 months of treatment. The authors present data from a randomized trial comparing results when acupuncture needles are placed in locations designed to address an overactive bladder against needles placed in locations designed for general relaxation. Both groups showed significant decreases in episodes of incontinence but only the group undergoing needle placement for overactive bladder reported significant decreases in urinary urgency and frequency. As with other treatments, the placebo effect was significant. Approximately 40% of women undergoing needle placement for relaxation saw improvement. Whether these results are sustainable beyond a 4-week trial remains to be determined but the technique is intriguing and certainly worth exploring for a common problem that is frequently difficult to manage. Peter C. Albertsen, M.D.
Long-Term Prospective Randomized Study Comparing Two Different Regimens of Oxybutynin as a Treatment for Detrusor Overactivity S. Salvatore, V. Khullar, L. Cardozo, R. Milani, S. Athanasiou and C. Kelleher, Divisione di Ginecologia Chirurgica, Ospedale Bassini, Universita di Milano, Milan, Italy Eur J Obstet Gynecol Reprod Biol, 119: 237–241, 2005 Objective: Prospective randomized trial to compare two low starting doses of oxybutynin, using an incremental regimen to assess patient compliance and treatment efficacy in the long-term. Study Design: Women with detrusor overactivity were included. Oxybutynin was randomly prescribed with a starting dose of either 2.5 mg bd or 5 mg nocte. Instructions were given to increase oxybutynin up to 5 mg tds over a period of 6 weeks fortnightly. After two years we re-contacted all the women, using a specific questionnaire to assess the efficacy, acceptability and compliance with these two different regimens. Twenty-two women in each group were calculated to show a 5% difference with a significance of 0.05 and a power of 0.9. The
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SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS chi2-test was used to compare the two groups and a P-value ⬍0.05 was considered significant. Results: Ninety-six women were included; 66 (68.75%) (mean age 57.5 years) responded to our questionnaire. Twenty-seven had a starting dose of 2.5 mg oxybutynin twice a day and 39 of 5 mg nocte. 34.8% complained of side effects. Only 19 (43.2%) out of the 44, not on medication anymore abandoned oxybutynin for adverse reactions. Most of the patients stopped oxybutynin within 4 months. 53.0% reported improvement or cure. 39.4% denied any benefit and 7.6% (none still on oxybutynin) did not answer. The two groups did not differ for duration of treatment, improvement with oxybutynin, maximum dose they reached, the present dose, and the present urinary symptoms. Conclusion: This study did not show any advantage in efficacy or compliance with oxybutynin when two different regimens of low starting were used. Two-thirds of patients discontinued the therapy within 4 – 6 months. Therefore, patients on anticholinergics should be reassessed after 6 months in clinical practice. Editorial Comment: Overactive bladder is a common medical condition that is frequently treated with anticholinergic medications. Unfortunately, long-term results are not frequently reported. This article clearly demonstrates that long-term compliance with medications is uncommon. More than two thirds of patients discontinued treatment within 4 months. Side effects, especially dry mouth, were the most common reason given for stopping medication. Half of the patients reported improvement in symptoms but randomized trials concerning treatment for overactive bladder frequently demonstrate a placebo response rate of more than 40%. Clinicians caring for patients with overactive bladder should consider scheduling followup visits at 3 and certainly 6 months to assess symptoms and compliance. Peter C. Albertsen, M.D.
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS Acupuncture for Overactive Bladder: A Randomized Controlled Trial S. L. Emmons and L. Otto, Department of Obstetrics and Gynecology, Oregon Health and Science University, Portland, Oregon Obstet Gynecol, 106: 138 –143, 2005 Objective: To compare acupuncture treatment for overactive bladder with urge incontinence with a placebo acupuncture treatment. Methods: Eighty-five women enrolled in this randomized, placebo-controlled trial. Women were randomly assigned to either receive an acupuncture treatment expected to improve their bladder symptoms, or a placebo acupuncture treatment designed to promote relaxation. They underwent cystometric testing, completed a 3-day voiding diary, and completed the urinary distress inventory and incontinence impact questionnaire, validated quality-of-life inventories, before and after 4 weekly acupuncture treatments. The primary endpoint was number of incontinent episodes over 3 days. Secondary endpoints included voiding frequency and urgency, cystometric bladder capacity, maximum voided volume, and the urinary distress inventory and incontinence impact questionnaire symptom scores. Results: Seventy-four women completed all aspects of the study. Women in both treatment and placebo groups had significant decreases in number of incontinent episodes (59% for treatment, 40% for placebo) without a significant difference in the change between the groups. Women in the treatment group had a 14% reduction in urinary frequency (P ⫽ .013), a 30% reduction in the proportion of voids associated with urgency (P ⫽ .016), and a 13% increase in both maximum voided volume and maximum cystometric capacity (P ⫽ .01). Both groups also had an improvement in the urinary distress inventory and incontinence impact questionnaire scores (54% decrease for treatment, 30% decrease for placebo, P ⬍.001 for the difference in change between the groups). Conclusion: Women who received 4 weekly bladder-specific acupuncture treatments had significant improvements in bladder capacity, urgency, frequency, and quality-of-life scores as compared with women who received placebo acupuncture treatments. Level of Evidence: I. Editorial Comment: One cannot watch the 6 o’clock news without appreciating that overactive bladder is a common medical condition. The most common treatments, anticholinergic medications, have significant side effects and are often only partially effective. Only about 18% of patients are compliant with these drugs after 6 months of treatment. The authors present data from a randomized trial comparing results when acupuncture needles are placed in locations designed to address an overactive bladder against needles placed in locations designed for general relaxation. Both groups showed significant decreases in episodes of incontinence but only the group undergoing needle placement for overactive bladder reported significant decreases in urinary urgency and frequency. As with other treatments, the placebo effect was significant. Approximately 40% of women undergoing needle placement for relaxation saw improvement. Whether these results are sustainable beyond a 4-week trial remains to be determined but the technique is intriguing and certainly worth exploring for a common problem that is frequently difficult to manage. Peter C. Albertsen, M.D.
Long-Term Prospective Randomized Study Comparing Two Different Regimens of Oxybutynin as a Treatment for Detrusor Overactivity S. Salvatore, V. Khullar, L. Cardozo, R. Milani, S. Athanasiou and C. Kelleher, Divisione di Ginecologia Chirurgica, Ospedale Bassini, Universita di Milano, Milan, Italy Eur J Obstet Gynecol Reprod Biol, 119: 237–241, 2005 Objective: Prospective randomized trial to compare two low starting doses of oxybutynin, using an incremental regimen to assess patient compliance and treatment efficacy in the long-term. Study Design: Women with detrusor overactivity were included. Oxybutynin was randomly prescribed with a starting dose of either 2.5 mg bd or 5 mg nocte. Instructions were given to increase oxybutynin up to 5 mg tds over a period of 6 weeks fortnightly. After two years we re-contacted all the women, using a specific questionnaire to assess the efficacy, acceptability and compliance with these two different regimens. Twenty-two women in each group were calculated to show a 5% difference with a significance of 0.05 and a power of 0.9. The
215
216
SOCIOECONOMIC FACTORS, UROLOGICAL EPIDEMIOLOGY AND PRACTICE PATTERNS chi2-test was used to compare the two groups and a P-value ⬍0.05 was considered significant. Results: Ninety-six women were included; 66 (68.75%) (mean age 57.5 years) responded to our questionnaire. Twenty-seven had a starting dose of 2.5 mg oxybutynin twice a day and 39 of 5 mg nocte. 34.8% complained of side effects. Only 19 (43.2%) out of the 44, not on medication anymore abandoned oxybutynin for adverse reactions. Most of the patients stopped oxybutynin within 4 months. 53.0% reported improvement or cure. 39.4% denied any benefit and 7.6% (none still on oxybutynin) did not answer. The two groups did not differ for duration of treatment, improvement with oxybutynin, maximum dose they reached, the present dose, and the present urinary symptoms. Conclusion: This study did not show any advantage in efficacy or compliance with oxybutynin when two different regimens of low starting were used. Two-thirds of patients discontinued the therapy within 4 – 6 months. Therefore, patients on anticholinergics should be reassessed after 6 months in clinical practice. Editorial Comment: Overactive bladder is a common medical condition that is frequently treated with anticholinergic medications. Unfortunately, long-term results are not frequently reported. This article clearly demonstrates that long-term compliance with medications is uncommon. More than two thirds of patients discontinued treatment within 4 months. Side effects, especially dry mouth, were the most common reason given for stopping medication. Half of the patients reported improvement in symptoms but randomized trials concerning treatment for overactive bladder frequently demonstrate a placebo response rate of more than 40%. Clinicians caring for patients with overactive bladder should consider scheduling followup visits at 3 and certainly 6 months to assess symptoms and compliance. Peter C. Albertsen, M.D.