PubMed Health⌕ Search

Biomedical subjects

Eboo Versi

Publications and source records attributed to Eboo Versi.

8 recordsLinked to original sources
PubMed2005

"Unblinding" in randomized controlled drug trials for urinary incontinence: Implications for assessing outcomes when adverse effects are evident.

AIMS: To determine whether women with urinary incontinence (UI) can identify their allocation in a randomized controlled trial (RCT) of tolterodine (TOL), and whether correct identification is associated with outcomes and adverse effects (AEs). METHODS: Exploratory analysis of a randomized, double-blind, placebo (PLC)-controlled trial of TOL 4 mg daily for 8 weeks in 743 women with urge-predominant mixed UI. Patient perception of their randomization was assessed at trial end. Main outcome measures were 7-day bladder diaries, patient perception of improvement, and UI-specific quality of life (QoL). RESULTS: TOL produced a significant decrease in urge UI episodes compared to PLC (78% vs. 51%, P = 0.0001). Fifty-one percent of women correctly identified their randomization (58% on TOL vs. 37% on PLC, P < 0.001). Women who assumed they took TOL had better bladder diary outcomes than those who assumed they took PLC. Within each assumption group, patient perception outcomes were similar, regardless of actual randomization. QoL improved in all domains except general health for women on TOL. In women who assumed they took TOL, significant drug benefit was evident in three domains. Moderate-severe dry mouth was higher in those who assumed they took TOL (7.3% vs. 0%, P < 0.0001). CONCLUSIONS: Greater than fifty percent of women in this RCT of antimuscarinic treatment were "unblinded" to their randomization. Patient assumption of randomization was associated with bladder diary and perception outcomes, specific QoL domains, and dry mouth. Efficacy of urge incontinence drugs should be considered in the context of patient assumptions, expectations, and "unblinding" by easily evident side effects.

Aged↗
PubMed2005

The role of urinary urgency and its measurement in the overactive bladder symptom syndrome: current concepts and future prospects.

OBJECTIVE: To review the concept of urinary urgency and its practical measurement in clinical trials, and advance the hypothesis that while urge is experienced by normal people, urgency is always pathological. METHODS: According to the International Continence Society (ICS) definition, urgency is the primary symptom of the overactive bladder (OAB) syndrome, but in clinical trials there are inconsistencies in both the definition and assessment of urgency. We searched the PubMed and BIOSIS databases for publications and abstracts related to the clinical assessment of urgency in patients with OAB. RESULTS: The differentiation of urgency from the normal physiological desire to void is discussed. In clinical studies of OAB, urgency has been measured both qualitatively and quantitatively. Existing qualitative assessment scales for urgency are deficient in accuracy, validation or both, and are largely inconsistent with the currently accepted ICS definition of urgency. The quantitative assessment of urgency by diary entry has been validated and may be the most accurate, reproducible and clinically meaningful method available for measuring this variable. CONCLUSION: Based on the existing ICS definition of urgency as 'a compelling desire to pass urine that is difficult to defer', the concept of qualitative assessment of urgency may be flawed.

Clinical Trials as Topic↗
PubMed2005

Validation of the urgency perception scale.

OBJECTIVE: To ascertain the validity and responsiveness of the Urgency Perception Scale (UPS) as an indicator of perceived urinary urgency. PATIENTS AND METHODS: The UPS was developed to assess perceived urinary urgency in clinical studies evaluating the efficacy of the antimuscarinic drug, tolterodine, for treating the overactive bladder (OAB) syndrome. Secondary analyses of clinical and patient assessment data from three clinical studies of tolterodine were conducted to evaluate the UPS. Construct validity was assessed by correlations between the UPS and patient voiding diary variables and other patient assessments, including: perception of bladder condition; perception of treatment benefit; the Medical Outcomes Study Short-Form 36 health survey; the King's Health Questionnaire; the OAB Questionnaire; and the Overall Treatment Effect scale. RESULTS: The UPS correlated well with the patients' perception of bladder condition (correlation coefficients - 0.29 to - 0.46; all P < 0.001) and with the voiding diary variables, especially incontinence episodes (-0.30 to - 0.41) and pad usage (-0.25 to - 0.38; all P < 0.001). An improvement in UPS score at the end of treatment was consistently reflected by significant improvements among all voiding variables. CONCLUSION: Urinary urgency is a central symptom of OAB and is particularly bothersome because of its unpredictability and consequent impact on daily life. The UPS is a valid scale by which urinary urgency can be assessed subjectively, and provides a useful tool for research into urinary urgency.

Aged↗
PubMed2004

Treatment of urge-predominant mixed urinary incontinence with tolterodine extended release: a randomized, placebo-controlled trial.

OBJECTIVES: To examine the efficacy and tolerability of antimuscarinic therapy in women with urge-predominant mixed incontinence. METHODS: This was a double-blind, randomized, placebo-controlled trial comprising 854 women with urge-predominant mixed incontinence, including urge incontinence (five or more episodes per week), urinary frequency (eight or more micturitions on average in 24 hours), and urgency in combination with stress incontinence. Women received 8 weeks of treatment with tolterodine tartrate extended-release (ER) 4 mg or placebo once daily. The outcome measures included urge incontinence episodes per week, stress incontinence episodes per week, micturition frequency per 24 hours, urgency episodes per 24 hours, volume voided per micturition, patient perception of bladder condition, and assessment of treatment benefit. RESULTS: After 8 weeks, tolterodine ER produced a statistically significant decrease in the weekly urge incontinence episodes compared with placebo (-12.3 versus -8.0; P <0.0001). Other micturition variables improved significantly more with tolterodine ER. No difference was found between treatment groups regarding the change in the number of stress incontinence episodes. A significantly greater proportion of patients receiving tolterodine ER than those receiving placebo reported improvement in bladder condition (61% versus 46%; P <0.001) and treatment benefit (76% versus 55%; P <0.001). After 8 weeks, the tolterodine ER group had experienced statistically significant improvements compared with the placebo group in 9 of 10 quality-of-life domains. The frequency of adverse events was similar between treatment groups. CONCLUSIONS: Tolterodine ER is an effective treatment of urge urinary incontinence, frequency, and urgency in women with concomitant stress urinary incontinence. The efficacy of tolterodine ER in reducing urge incontinence episodes was unaffected by the presence of stress incontinence. The results of this study support the first-line use of antimuscarinic therapy to treat the urge incontinence component of urge-predominant mixed incontinence.

Adult↗
PubMed2004

Efficacy of antimuscarinic therapy for overactive bladder with varying degrees of incontinence severity.

PURPOSE: We analyze the efficacy of tolterodine extended release (ER) for overactive bladder in patients with severe incontinence. MATERIALS AND METHODS: Patients with urinary frequency (8 micturitions or greater per 24 hours), urge incontinence (5 episodes or greater a week) and symptoms of overactive bladder for 6 months or greater were randomized to treatment with 4 mg tolterodine ER once daily or placebo for 12 weeks. Severe incontinence was defined as 21 episodes or greater per week at baseline. Changes in the number of incontinence episodes per week and micturition frequency after 12 weeks were compared between treatments. RESULTS: A total of 986 patients were eligible for this post-hoc analysis. After 12 weeks tolterodine ER produced a significant absolute median reduction in incontinence episodes per week compared to placebo (9.0 vs 5.0, p <0.0001). For patients with severe incontinence at baseline median absolute and percentage reductions in incontinence episodes per week were significantly greater with tolterodine ER than placebo (21.0 vs 9.5, p <0.0001; 67.6% vs 29.8%, p = 0.022). Micturition frequency decreased (p <0.02) and volume voided per micturition (p <0.0001) increased significantly more with tolterodine ER compared with placebo in these patients. For patients with nonsevere incontinence at baseline median reductions in incontinence episodes per week were also significantly greater with tolterodine ER than placebo (6.0 vs 4.0, p <0.0001; 71.4% vs 38.5%, p = 0.026). CONCLUSIONS: Patients with more severe incontinence at baseline achieved greater absolute reductions in incontinence with tolterodine compared to those with less severe symptoms. The degree of improvement, as measured by percent change, was comparable across the entire range of baseline incontinence severity strata. Benefits of antimuscarinic therapy may be greater in these patients than previously reported.

Female↗
PubMed2004

Validation of a clinical algorithm to diagnose stress urinary incontinence for large studies.

PURPOSE: We assessed the accuracy with which a clinical diagnostic algorithm for stress urinary incontinence (SUI) based on symptoms and signs without including urodynamics predicted the observation of urodynamic SUI and the condition of SUI. Such an algorithm would have applicability to ensure that the majority of women entering large SUI clinical trials would have urodynamic SUI and/or the condition of SUI without performing urodynamic testing in all subjects. MATERIALS AND METHODS: A total of 1455 women with urinary incontinence at least 3 months in duration were enrolled in 3 randomized clinical trials (1 phase 2 and 2 phase 3 trials) of duloxetine vs placebo for the treatment of SUI in Europe and North America. Subjects were identified as having SUI based on a clinical algorithm that required a predominant symptom of SUI with a weekly incontinence episode frequency of 4 or greater (phase 2 study), or 7 or greater (phase 3 studies), absent predominant urge symptoms, normal diurnal and nocturnal frequency, a bladder capacity of 400 ml or greater, and a positive cough stress (sign of SUI) and stress pad test. Multichannel urodynamic studies were performed in a subset of 184 women at 23 study sites. Of these urodynamic tracings 173 (94%) were of adequate quality to make an assessment of the filling phase and assign a diagnosis of urodynamic SUI, detrusor overactivity or a normal filling phase. Two-sided 95% exact CIs for the proportions were calculated. RESULTS: The clinical algorithm had a positive predictive value of 90.2% for urodynamic SUI with or without detrusor overactivity and 76.9% for urodynamic SUI only (pure urodynamic SUI). The positive predictive value for the condition of pure SUI was 85.0%, while for the condition of SUI in pure and mixed forms the positive predictive value was 98.3%. Patient age, previous continence surgery or the severity of incontinence did not influence algorithm accuracy. CONCLUSIONS: The algorithm is suitably feasible and sufficiently predictive to be used in large clinical trials designed to evaluate conservative treatment for women with SUI. It ensures that the overwhelming majority of the study population would have urodynamic SUI and the condition of SUI.

Adult↗
PubMed2004

A systematic review of the effects of estrogens for symptoms suggestive of overactive bladder.

OBJECTIVE: To perform a systematic review of the effects of estrogen therapy on symptoms suggestive of overactive bladder (OAB) in postmenopausal women. MATERIALS AND METHODS: This analysis involved a literature review of Medline, Excerpta Medica, and the Science Citation Index and a manual search of popular urology, gynecology, gerontology, and primary care medicine journals from January 1969 to December 1999. Articles had to include estrogen and placebo treatment groups, published or original data presented at a scientific meeting and report symptoms suggestive of OAB. This search identified 11 randomized trials and included a total of 430 subjects. Thirty-six subjects who participated in two crossover studies received both estrogen and placebo and thus are counted twice, therefore 236 received estrogen therapy and 230 were placebo controls. Estrogen was administered systemically or locally as estriol, estradiol, conjugated estrogen, or estradiol and estriol. A meta-analysis of these studies was performed for all estrogen therapies and then separately for systemic and local therapies. RESULTS: Overall, estrogen therapies were associated with statistically significant improvements in all outcome variables: diurnal frequency (P = 0.0011), nocturnal frequency (P = 0.0371), urgency (P = 0.0425), number of incontinence episodes (P = 0.0002), first sensation to void (P = 0.0001), and bladder capacity (P = 0.0018). Local therapies had statistically significant beneficial effects on all outcome variables. However, systemic therapies were only associated with significant improvements in incontinence episodes and first sensation to void while nocturnal frequency actually worsened. CONCLUSION: Estrogen therapy may be effective in alleviating the symptoms suggestive of OAB. Local administration may be the most beneficial route of administration.

Cross-Over Studies↗