Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial

Vardy, Michael D.; Mitcheson, H. David; Samuels, T.A.; Wegenke, John D.; Forero-Schwanhaeuser, Sergio; Marshall, Thomas; He, Weizhong

doi:10.1111/j.1742-1241.2009.02209.x

Cited by 56 publications

(48 citation statements)

References 29 publications

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“…A total of 13 publications were identified, from which ten unique studies were included in the review ( Fig. 1) [6,7,[9][10][11][12][13][14][15][16][17][18][19]. The characteristics and quality of the included studies are presented in Table 1.…”

Section: Literature Flowmentioning

confidence: 99%

Solifenacin for overactive bladder: a systematic review and meta-analysis

et al. 2012

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This study aims to evaluate the efficacy and safety of solifenacin for treating overactive bladder. Randomized controlled trials (RCTs) were identified and extracted from MEDLINE, Embase, and CENTRAL. The quality of the included RCTs was assessed using the Jadad score, and heterogeneity was analyzed using the chi-squared test. The data of the included RCTs were collected, extracted, and assessed by our protocol. A total of nine RCTs were identified from the search strategy. Compared with the placebo and tolterodine treatments, both short-term (mostly 12-week) trials indicated that solifenacin significantly reduced urgency episodes, micturitions, and incontinence episodes per 24 h. Compared with the solifenacin (5 mg) group, the solifenacin (10 mg) group was significantly better in terms of the number of micturitions per 24 h. With regard to adverse effects, the patients treated with solifenacin had significantly higher rates of constipation and blurred vision than patients treated with tolterodine. The solifenacin therapy was not inferior to tolterodine in terms of efficacy profiles and had a similar incidence of overall adverse events compared with tolterodine treatment. Solifenacin (5 mg) is thus a recommended dose because of its reported balance between efficacy and acceptable tolerability.

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Section: Literature Flowmentioning

confidence: 99%

Solifenacin for overactive bladder: a systematic review and meta-analysis

et al. 2012

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“…It is thought that relaxing these smooth muscles decreases bladder outlet resistance and voiding pressure, with beneficial effect on stent related LUTS [7, 10]. Solifenacin acts as a muscarinic receptor antagonist used for treatment of patients with overactive bladder (OAB) [12, 13] and might be effective as well for stent-related symptoms [8–10]. …”

Section: Introductionmentioning

confidence: 99%

Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms

Shalaby

Ahmed

Maarouf

et al. 2013

Advances in Urology

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Purpose. We evaluated the effectiveness and safety of tamsulosin, solifenacin, and combination of both in reducing double-J stent-related lower urinary symptoms. Materials and Methods. A total of 338 patients with double-J ureteral stenting were randomly divided, postoperatively, into 4 groups. In group I (n = 84), no treatment was given (control group), group II (n = 85) received tamsulosin 0.4 mg daily, group III (n = 84) received solifenacin 10 mg daily, and group IV (n = 85) received a combination of both medications. Before insertion and 2 weeks after, all patients completed the International Prostate Symptom Score (IPSS), quality of life component of the IPSS (IPSS/Qol), Overactive Bladder Questionnaire (OAB-q), and Visual Analogue Pain Scale (VAPS) questionnaire. Results. The demographics and preoperative questionnaires scores of all groups were comparable. There were statistically significant differences in all scores in favour of groups II, III, and IV as compared to control group (P value < 0.005). Group IV showed statistically significant differences in total IPSS, QoL score, and OAB-q score as compared to groups II and III (P value < 0.001). Conclusions. Combined therapy of tamsulosin and solifenacin significantly alleviated lower urinary symptoms associated with double-J stents as compared to either medication alone.

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“…At baseline and week 12, patients completed the PPBC (17); a 100‐mm Treatment Satisfaction Visual Analog Scale (TS‐VAS); Benefit, Satisfaction and Willingness to Continue (BSW) measure (18); and the Work Productivity and Activity Impairment (WPAI) questionnaire (19). During VIBRANT, patients also completed the Medical Care and Use Index (MCUI) and the International Consultation on Incontinence Modular Questionnaire – Male/Female Sexual Matters associated with Lower Urinary Tract Symptoms (ICIQ‐M/FLUTSsex); these results have been published elsewhere (15). The primary end‐point for the VIBRANT study was mean change from baseline to end of treatment on the OAB‐q Symptom Bother scale.…”

Section: Methodsmentioning

confidence: 99%

“…More recently, the group performed a post hoc analysis of data from a double‐blind, placebo‐controlled trial of tolterodine ER to evaluate the relationships between improvements in urgency urinary incontinence episodes and PROs (14). Here, we report findings from a post hoc analysis from VIBRANT ( V ESIcare ® I nvestigation of B othe R A nd quality of life i N subjec T s with OAB), the first controlled OAB clinical trial to assess the efficacy of an antimuscarinic using a PRO measure, the OAB Questionnaire (OAB‐q) Symptom Bother scale, as the primary efficacy end‐point (15).…”

Section: Introductionmentioning

confidence: 99%

Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study

Crosby

Mathias

Marshall

2011

International Journal of Clinical Practice

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Summary Aims: Studies of antimuscarinics for overactive bladder (OAB) typically use objective and subjective measures to assess efficacy, as each provides unique information about patient outcome. We evaluated the relationships between changes in diary‐documented OAB symptoms and other patient‐reported outcome (PRO) measures. Methods: In VIBRANT, OAB patients received solifenacin (5/10 mg) or placebo for 12 weeks. During the study, patients completed 3‐day bladder diaries and other generic and disease‐specific PRO measures. Data from both treatment groups were combined (n = 738). Categorical changes in diary variables were compared with changes in PRO measures. Partial correlations controlling for treatment and Spearman correlations were also calculated. Results: Categorical improvements in diary variables were significantly associated with greater improvements in PRO measures. Pair‐wise comparisons showed that patients with major symptomatic improvements had significantly greater improvements on PROs vs. those with some or no improvement. Odds ratios ranged from 1.52 to 4.09 (p ≤ 0.002). Linear relationships between changes in PRO measures and diary variables were low to moderate but statistically significant (p < 0.001). Partial correlations were highest for diary variables and OAB‐Questionnaire Symptom Bother. Spearman correlations ranged from 0.170 to 0.450 (p < 0.001). Conclusions: In patients with OAB, changes in objectively measured symptoms of urgency, incontinence and frequency showed low‐to‐moderate correlations to changes in PRO measures. While providing evidence for similar change patterns in symptoms and patient perceptions, correlations were not high, lending support to the concept that in OAB clinical trials, both bladder diaries and PRO measures are important independent measures of efficacy.

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Effects of solifenacin on overactive bladder symptoms, symptom bother and other patient-reported outcomes: results from VIBRANT - a double-blind, placebo-controlled trial

Cited by 56 publications

References 29 publications

Solifenacin for overactive bladder: a systematic review and meta-analysis

Solifenacin for overactive bladder: a systematic review and meta-analysis

Randomized Controlled Trial to Compare the Safety and Efficacy of Tamsulosin, Solifenacin, and Combination of Both in Treatment of Double-J Stent-Related Lower Urinary Symptoms

Relationships between symptoms, symptom bother, and health-related quality of life in patients with overactive bladder taking solifenacin or placebo in the VIBRANT study

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