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Effect of tamsulosin versus prazosin on clinical and urodynamic parameters in women with voiding difficulty: a randomized clinical trial.

ABSTRACT: OBJECTIVE:To compare the effects of tamsulosin and prazosin on clinical and urodynamic parameters in women with voiding dysfunction. METHODS:Forty women aged 20-65 years with a clinical diagnosis of voiding dysfunction were blindly randomized to two equal groups for treatment with tamsulosin 0.4 mg or 1-2 mg of prazosin daily. Symptom assessment with the American Urological Association Symptom Score (AUASS) and urodynamic evaluation was performed initially and after three months of treatment. Patient satisfaction was evaluated and severe adverse drug effects recorded. Statistical analysis was carried out using the Student's t-test and Mann-Whitney U test. RESULTS:Although AUASS improved in both groups, the rate of improvement was larger in the tamsulosin group. Urodynamic parameters improved but did not normalize in both groups. Adverse side effects from medication in the prazosin group were more common than in the tamsulosin group. Most of the patients in the tamsulosin group (80%) were satisfied with their treatment compared with those in the prazosin group (45%). CONCLUSION:Tamsulosin and prazosin are both effective in palliating symptoms of women with voiding dysfunction and improving their urodynamic parameters. Tamsulosin may be the preferred drug to prescribe because of its more amenable side effect profile and greater patient satisfaction.

SUBMITTER: Hajebrahimi S

PROVIDER: S-EPMC3056329 | biostudies-literature | 2011 Jan

REPOSITORIES: biostudies-literature

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Effect of tamsulosin versus prazosin on clinical and urodynamic parameters in women with voiding difficulty: a randomized clinical trial.

Hajebrahimi Sakineh S Asrbadr Yadollah Ahmadi YA Azaripour Arash A Sadeghi-Bazargani Homayoun H

International journal of general medicine 20110111

<h4>Objective</h4>To compare the effects of tamsulosin and prazosin on clinical and urodynamic parameters in women with voiding dysfunction.<h4>Methods</h4>Forty women aged 20-65 years with a clinical diagnosis of voiding dysfunction were blindly randomized to two equal groups for treatment with tamsulosin 0.4 mg or 1-2 mg of prazosin daily. Symptom assessment with the American Urological Association Symptom Score (AUASS) and urodynamic evaluation was performed initially and after three months o ...[more]

PMID: 21403790

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Project description:ImportanceUrinary stone disease is a common presentation in the emergency department, and α-adrenergic receptor blockers, such as tamsulosin, are commonly used to facilitate stone passage.ObjectiveTo determine if tamsulosin promotes the passage of urinary stones within 28 days among emergency department patients.Design, setting, and participantsWe conducted a double-blind, placebo-controlled clinical trial from 2008 to 2009 (first phase) and then from 2012 to 2016 (second phase). Participants were followed for 90 days. The first phase was conducted at a single US emergency department; the second phase was conducted at 6 US emergency departments. Adult patients were eligible to participate if they presented with a symptomatic urinary stone in the ureter less than 9 mm in diameter, as demonstrated on computed tomography.InterventionsParticipants were randomized to treatment with either tamsulosin, 0.4 mg, or matching placebo daily for 28 days.Main outcomes and measuresThe primary outcome was stone passage based on visualization or capture by the study participant by day 28. Secondary outcomes included crossover to open-label tamsulosin, time to stone passage, return to work, use of analgesic medication, hospitalization, surgical intervention, and repeated emergency department visit for urinary stones.ResultsThe mean age of 512 participants randomized to tamsulosin or placebo was 40.6 years (range, 18-74 years), 139 (27.1%) were female, and 110 (22.8%) were nonwhite. The mean (SD) diameter of the urinary stones was 3.8 (1.4) mm. Four hundred ninety-seven patients were evaluated for the primary outcome. Stone passage rates were 50% in the tamsulosin group and 47% in the placebo group (relative risk, 1.05; 95.8% CI, 0.87-1.27; P = .60), a nonsignificant difference. None of the secondary outcomes were significantly different. All analyses were performed according to the intention-to-treat principle, although patients lost to follow-up before stone passage were excluded from the analysis of final outcome.Conclusions and relevanceTamsulosin did not significantly increase the stone passage rate compared with placebo. Our findings do not support the use of tamsulosin for symptomatic urinary stones smaller than 9 mm. Guidelines for medical expulsive therapy for urinary stones may need to be revised.Trial registrationClinicalTrials.gov Identifier: NCT00382265.

Project description:Urodynamic studies are commonly performed in women before surgery for stress urinary incontinence, but there is no good evidence that they improve outcomes.We performed a multicenter, randomized, noninferiority trial involving women with uncomplicated, demonstrable stress urinary incontinence to compare outcomes after preoperative office evaluation and urodynamic tests or evaluation only. The primary outcome was treatment success at 12 months, defined as a reduction in the score on the Urogenital Distress Inventory of 70% or more and a response of "much better" or "very much better" on the Patient Global Impression of Improvement. The predetermined noninferiority margin was 11 percentage points.A total of 630 women were randomly assigned to undergo office evaluation with urodynamic tests or evaluation only (315 per group); the proportion in whom treatment was successful was 76.9% in the urodynamic-testing group versus 77.2% in the evaluation-only group (difference, -0.3 percentage points; 95% confidence interval, -7.5 to 6.9), which was consistent with noninferiority. There were no significant between-group differences in secondary measures of incontinence severity, quality of life, patient satisfaction, rates of positive provocative stress tests, voiding dysfunction, or adverse events. Women who underwent urodynamic tests were significantly less likely to receive a diagnosis of overactive bladder and more likely to receive a diagnosis of voiding-phase dysfunction, but these changes did not lead to significant between-group differences in treatment selection or outcomes.For women with uncomplicated, demonstrable stress urinary incontinence, preoperative office evaluation alone was not inferior to evaluation with urodynamic testing for outcomes at 1 year. (Funded by the National Institute of Diabetes and Digestive and Kidney Diseases and the Eunice Kennedy Shriver National Institute of Child Health and Human Development; ClinicalTrials.gov number, NCT00803959.).

Dataset Information

Effect of tamsulosin versus prazosin on clinical and urodynamic parameters in women with voiding difficulty: a randomized clinical trial.

Publications

Effect of tamsulosin versus prazosin on clinical and urodynamic parameters in women with voiding difficulty: a randomized clinical trial.

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