Effect of fluid management on fluid intake and urge incontinence in a trial for overactive bladder in women

Study Type – Therapy (RCT)
Level of Evidence 1b

OBJECTIVES

To explore whether instruction in fluid management resulted in changes in fluid intake and incontinence over a 10‐week study period in women with urinary urge incontinence (UUI), as fluid management might be a critical strategy in treating this condition.

PATIENTS AND METHODS

In the ‘Behaviour Enhances Drug Reduction of Incontinence’ trial, women with predominant UUI were randomized to daily treatment with tolterodine or tolterodine combined with behavioural therapies, among which were individualized instructions on fluid management. Patients in both groups received general fluid management instructions, while in the drug + behaviour arm, those with excessive urine output (>2.1 L/day) had additional individualized instruction during each of four study visits to learn behavioural strategies. Variables measured at baseline and at 10 weeks were type of incontinence, using the Medical, Epidemiological, and Social Aspects of Aging questionnaire, severity of incontinence by number of incontinence episodes based on a 7‐day diary, number of voids/24 h (F₂₄), urgency rating, 24‐h fluid intake (I₂₄) and 24‐h volume voided (V₂₄), volume average (V_avg), pad use, bothersomeness of UUI (Urogenital Distress Inventory and Overactive Bladder questionnaire), and quality of life (Incontinence Impact Questionnaire‐7 and Short‐Form‐12).

RESULTS

Leakage episodes/24 h, V₂₄, I₂₄ and average urgency ratings all significantly decreased from baseline to 10 weeks (P < 0.001 for each). V_avg increased (P < 0.001), as did voids/L intake (P = 0.01). None of the changes in diary variable outcomes differed by treatment group after accounting for these changes between baseline and 10 weeks. In a multivariable model, treatment group was not associated with change in V₂₄ from baseline to 10 weeks (P = 0.81), but the difference in the number of accidents/diary day, F₂₄, I₂₄, and average voids/day each were positively related with the change in V₂₄ (P < 0.001 for each). Patients had a response to fluid management instructions; the decrease in the percentage of women with a V₂₄ of >2.1 L between baseline and follow‐up was statistically significant (P = 0.01 McNemar’s test).

CONCLUSION

General fluid instructions can contribute to the reduction in UUI symptoms for women taking anticholinergic medications, but additional individualized instructions along with other behavioural therapies did little to further improve the outcome.     

Prevalence and correlation of urinary incontinence and overactive bladder in Taiwanese women

AIMS: We randomly sampled a community-based, healthy population to evaluate the prevalence and correlation of urinary incontinence and overactive bladder. We also assessed the influences of these conditions on quality of life and associated risk factors. METHODS: Of the 1,581 women sampled (2.92% of registered female residents aged 20 years and older), 1,253 (79.1%) women were successfully interviewed by using the Bristol Female Urinary Tract Symptoms Questionnaire (r=0.87, P<0.05) and the Questionnaire of Impact index regarding the impact on quality of life (r=0.91, P<0.05). RESULTS: A total of 53.7% of the women sampled suffered from urinary incontinence and related symptoms. The prevalence of stress urinary incontinence, overactive bladder, and mixed incontinence, mutually exclusive of each, was 18.0%, 18.6%, and 17.1%, respectively, from the patients' perceptions. Judging by the criteria of the International Continence Society, the prevalence of the above three conditions was 4.3%, 2.4%, and 1.8%, respectively. Of the women who perceived storage symptoms, 21.1% experienced frequency, 12.6% had urgency, 25.5% had nocturia, and 9.1% had urge incontinence. The occurrence of stress urinary incontinence increased with age up to 65 years old (25% in 50-65-year-old cohort), and the number of overactive bladder conditions significantly increased in the elderly women (over 65 years old, 39.3%). Approximately two thirds of the incontinent women had restricted their social activities (due to worrying about wetting or leakage and no toilet facilities available), and approximately 19% of the incontinent women had an affected sexual life. However, only 27.1% of the women with urinary incontinence and related symptoms in this study had reported seeking medical services to solve these problems. CONCLUSIONS: The prevalence of urinary incontinence and overactive bladder in Taiwanese women is similar to that of Western women.     

Validity and reliability of the patient's perception of intensity of urgency scale in overactive bladder

Study Type – Prognosis (outcomes research)
Level of Evidence 2c What’s known on the subject? and What does the study add? Improvement in urinary urgency is an important goal for patients with overactive bladder, and should be measured along with change in other key symptoms in overactive bladder clinical trials. Existing scales that measure urinary urgency during completion of a bladder diary have incomplete evidence of validity. Used as part of a 3‐day bladder diary the Patient’s Perception of Intensity of Urgency Scale has good test‐retest reliability and responsiveness. It correlates with other measures of condition severity, and distinguishes well between patient groups. The scale should therefore be useful both in clinical practice and in research.

OBJECTIVE

• ? To assess the measurement characteristics of the Patient Perception of Intensity of Urgency Scale (PPIUS) in patients with overactive bladder (OAB).

PATIENTS AND METHODS

• ? Adult women with at least a 3‐month history of OAB. The design was a 4‐week, double‐blind, randomized, placebo‐controlled trial of transdermal oxybutynin, with a 2‐week placebo run‐in and 8‐week, open‐label extension.
• ? Symptom improvement was assessed using 3‐day bladder diaries incorporating the PPIUS, and disease‐specific health‐related quality of life was assessed using the King’s Health Questionnaire (KHQ). Convergent validity was shown by correlation with the KHQ, and other bladder diary variables. Known groups validity was assessed by comparison of baseline mean urge ratings, and urgency episode frequency for continent and incontinent patients, and by comparison with the same measures from a historical control group of 40 asymptomatic female volunteers.
• ? Between‐ and within‐groups responsiveness was assessed using standardized effect sizes (Cohen’s d and effect size r). Reliability was assessed for the two arms of the trial at different time points and intervals, using intraclass correlation (ICC) and a t‐test for the difference between mean scores.

RESULTS

• ? In total, 96 women were randomized. Urgency episode frequency showed moderate correlation with total KHQ score (r= 0.500, P < 0.001) and with daytime and night‐time voiding frequency.
• ? There were significant differences in continent and incontinent subgroups for mean urge ratings (difference in means, ?0.61/void, P < 0.001), and urgency episodes (difference in means, ?2.67 episodes/day, P < 0.001), as well as between OAB patients and normal controls (mean urge rating: difference in means 1.22 per void, P < 0.001; urgency episodes: difference in means 2.93 episodes/day, P < 0.001).
• ? Between‐groups analysis of effect size found that urgency episode frequency (d= 0.679, r= 0.321) was more responsive than mean urge rating (d= 0.480, r= 0.233). In both subgroups, urgency episode frequency (d= 0.421–0.454, r= 0.206–0.222) had better within‐groups responsiveness than mean urge rating.
• ? Urgency episodes (ICC, 0.65–0.81) were measured more reliably than urgency urinary incontinence episodes (ICC, 0.50–0.65).

CONCLUSIONS

• ? Assessment of urgency episodes using the PPIUS shows good reliability, excellent known groups validity, high responsiveness and convergence with subjective measures of severity.
• ? PPIUS is freely available, and should be useful in both clinical practice and research studies when assessing women with urgency, with or without urgency urinary incontinence.

     

Comparison of doxazosin with or without tolterodine in men with symptomatic bladder outlet obstruction and an overactive bladder

OBJECTIVE: To assess the efficacy of combined treatment with doxazosin and tolterodine, as although alpha-blockers are commonly used and generally effective in men with symptomatic bladder outlet obstruction (BOO), a subset of men with BOO and overactive bladder (OAB) symptoms often complain of persistent symptoms. PATIENTS AND METHODS: In a prospective study of 144 consecutive men with BOO at one tertiary urology centre, all had a baseline pressure-flow urodynamic study and were then subdivided into those with BOO or BOO + OAB, based on absence or presence of involuntary detrusor contractions. The Abrams-Griffiths nomogram was used to determine obstructive BOO. After the initial evaluation, all patients were treated with doxazosin 4 mg/day for 3 months. In patients with no symptomatic improvement, tolterodine 2 mg twice daily was added for an additional 3 months. RESULTS: Of the 144 patients, 76 (53%) were diagnosed as having BOO and 68 (47%) BOO + OAB. The patients with BOO + OAB were older (P < 0.05) and had a higher International Prostate Symptom Score. After 3 months of treatment with doxazosin, 60 (79%) with BOO and 24 (35%) BOO + OAB reported a symptomatic improvement. In those patients with no improvement, six of 16 with BOO and 32 of 44 (73%) with BOO + OAB improved after adding tolterodine. Acute urinary retention developed in only two of 60 men (3.3%) treated with the combined therapy. CONCLUSION: About half of men with symptomatic BOO had an OAB; while about three-quarters of men with symptomatic BOO and no OAB improved with doxazosin, only a third with BOO + OAB were helped with doxazosin alone. Combining tolterodine with doxazosin was effective in three-quarters of men with BOO + OAB. Overall, most men with BOO with or with no OAB were helped with doxazosin alone or with the addition of tolterodine.     

Efficacy and tolerability of tolterodine extended-release in men with overactive bladder and urgency urinary incontinence

A group of authors from the USA evaluated the efficacy and tolerability of tolterodine extended-release on objective and subjective endpoints in men with an overactive bladder. They found that it significantly reduced incontinent episodes and improved patient perception of treatment benefit in men with an overactive bladder OBJECTIVE: To evaluate the efficacy and tolerability of tolterodine extended-release (ER) on objective and subjective endpoints in men with overactive bladder (OAB) and urgency urinary incontinence (UI). PATIENTS AND METHODS This was a post hoc analysis of data collected from men with OAB enrolled in a 12-week, double-blind, placebo-controlled trial of tolterodine ER (4 mg once daily; tolterodine ER registration trial) and included men with urinary frequency (> or =8 micturitions/24 h) and urgency UI (> or =5 episodes/week). UI episodes were assessed using 7-day bladder diaries. Patient perception of treatment benefit was evaluated after 12 weeks. Adverse events (AEs) were recorded throughout the study. RESULTS: In all, 163 men with OAB (placebo, 86; tolterodine ER, 77; mean age 65 years) were evaluated. Baseline demographics and clinical characteristics were similar for the two treatment groups. Compared with placebo, tolterodine ER significantly reduced weekly UI episodes (median % change, -71% vs - 40%, P < 0.05; mean numeric change, - 11.9 vs -5.9, P = 0.02). Men receiving tolterodine ER had fewer micturitions/24 h, but this was not a significant difference from placebo (median % change, -12% vs - 4%, P = 0.22). Significantly more men treated with tolterodine-ER (63%) than placebo-treated men (46%) reported a benefit of treatment after 12 weeks (P = 0.04). The most commonly reported AEs associated with tolterodine-ER vs placebo were dry mouth (16% vs 7%), constipation (4% vs 9%), dyspepsia (4% vs 1%), dizziness (5% vs 1%), and somnolence (3% vs 1%). One of the men receiving tolterodine ER had symptoms suggestive of urinary retention that led to his withdrawal from the study. None of the men had acute urinary retention requiring catheterization. CONCLUSION: In men with OAB and urgency UI, tolterodine ER was well tolerated and significantly reduced episodes of urgency UI, and improved patient perception of treatment benefit.     

Medical visits among adults with symptoms commonly associated with an overactive bladder

OBJECTIVES: To examine nationally representative data and thus obtain estimates of the use of healthcare providers associated with the overactive bladder (OAB) symptoms, a condition characterized by frequency, urgency and nocturia, with or with no urge incontinence, as although it is ranked among the 10 most common chronic medical conditions in the USA, the level of OAB-associated medical treatment remains largely unknown. METHODS: To estimate the number of annual OAB-associated medical visits among patients aged > or =18 years, three national databases in the USA (year 2000) were examined: the National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey, and the National Hospital Discharge Survey. Population estimates were constructed using design-based statistical analyses to account for the complex survey designs of data. RESULTS: During 2000, adult Americans made 1.4 million (95% confidence interval 1.1-1.8 million) ambulatory visits to non-Federal office-based physicians with International Classification of Disease (ICD-9) coding indicative of OAB symptoms. Accounting for emergency and outpatient department visits, as well as non-Federal short-stay hospital discharges, the estimated number of medical visits with OAB-associated ICD-9 coding was <1.5 million. CONCLUSION: The prevalence of OAB was estimated to be 34 million adult Americans. When 1.4 million ambulatory visits were compared with this prevalence, as few as 4% of adult Americans with OAB sought medical treatment during the year 2000. The present results therefore suggest a large unmet medical need among the population of adult Americans with OAB.     

Nutrient composition of the diet and the development of overactive bladder: a longitudinal study in women

AIMS: Evidence for an association between diet and the symptom syndrome overactive bladder (OAB) would be valuable in understanding its aetiology. The present study investigates prospectively the association between the nutrient composition of the diet and the onset of OAB. METHODS: A random sample of community dwelling women aged 40 years or over was studied. Baseline data on urinary symptoms and diet were collected from 6,371 women using a postal questionnaire and food frequency questionnaire. Follow-up data on urinary symptoms were collected from 5,816 of the women in a postal survey 1 year later. Logistic regression was used to investigate the association of diet (daily intakes of energy, macro and micronutrients) with 1 year incidence of OAB. RESULTS: There was evidence that three nutrients may be associated with OAB onset. Higher intakes of vitamin D (P = 0.008), protein (P = 0.03), and potassium (P = 0.05) were significantly associated with decreased risks of onset. Although overall the associations with vitamin B6 and niacin were not significant (P = 0.08 and P = 0.13), there was some evidence of a decreased risk of onset with higher intakes. CONCLUSIONS: The results from this prospective study suggest possible aetiological associations between certain nutrients and OAB onset. The findings need confirmation and possible mechanisms to explain these associations need further investigation.