Tags

Type your tag names separated by a space and hit enter

Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms.
Curr Med Res Opin. 2010 Oct; 26(10):2277-85.CM

Abstract

OBJECTIVE

It is widely recognized that patient perception of overactive bladder (OAB) symptoms can vary considerably from mild to severe bother. This post hoc analysis reports outcomes in patients with severe OAB symptoms at baseline taken from the VESIcare Efficacy and Safety in PatieNts with Urgency Study (VENUS).

METHODS

VENUS was a 12-week, randomized, double-blind, placebo-controlled trial of solifenacin (5 or 10 mg/day, flexibly dosed) in OAB patients. The primary endpoint in VENUS was mean change from baseline to study end in urgency episodes/day using 3-day bladder diaries. Secondary endpoints included other diary endpoints (frequency, incontinence, and nocturia), warning time (WT; time between first sensation of urgency to voiding), and patient-reported outcome (PRO) measures of urgency (the Indevus Urgency Severity Scale [IUSS] and Urgency Perception Scale [UPS]) and of symptom bother and health-related quality of life (HRQL) (the Patient Perception of Bladder Condition [PPBC] and Overactive Bladder Questionnaire). For this analysis, severe OAB was defined as baseline PPBC score ≥5 (1 = no problems, 6 = many severe problems).

TRIAL REGISTRATION

NCT00454896.

RESULTS

In total, 158/707 (22.3%) patients in the full analysis set (FAS) reported severe OAB symptoms. Solifenacin reduced mean urgency episodes/day versus placebo in the severe subgroup (-4.6 vs. -3.1, p = 0.1150), similar to the significant reduction observed in the FAS (-3.9 vs. -2.7, p < 0.0001). Solifenacin also improved the other diary endpoints and PRO measures in the severe subgroup; these changes were consistent with the significant solifenacin- versus placebo-related improvements for the FAS. Treatment-emergent adverse events were mostly mild/moderate, and few patients taking solifenacin or placebo discontinued treatment in the severe subgroup (4.5% vs. 6.5%) or FAS (6.5% vs. 4.6%). Key limitations are that VENUS was not powered to detect treatment differences in subgroups, and that the lack of a standardized definition of OAB symptom severity may limit the generalizability of the findings.

CONCLUSIONS

Patients with severe OAB symptoms showed objective and subjective improvements in symptoms, symptom bother, HRQL, and urgency severity with solifenacin similar to the FAS. Solifenacin was also well-tolerated in this subgroup.

Authors+Show Affiliations

Bladder Control Center of Norwalk, Norwalk, CT 06850, USA. scottserels@hotmail.comNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

20707767

Citation

Serels, Scott R., et al. "Impact of Solifenacin On Diary-recorded and Patient-reported Urgency in Patients With Severe Overactive Bladder (OAB) Symptoms." Current Medical Research and Opinion, vol. 26, no. 10, 2010, pp. 2277-85.
Serels SR, Toglia MR, Forero-Schwanhaeuser S, et al. Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Curr Med Res Opin. 2010;26(10):2277-85.
Serels, S. R., Toglia, M. R., Forero-Schwanhaeuser, S., & He, W. (2010). Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. Current Medical Research and Opinion, 26(10), 2277-85. https://doi.org/10.1185/03007995.2010.509582
Serels SR, et al. Impact of Solifenacin On Diary-recorded and Patient-reported Urgency in Patients With Severe Overactive Bladder (OAB) Symptoms. Curr Med Res Opin. 2010;26(10):2277-85. PubMed PMID: 20707767.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Impact of solifenacin on diary-recorded and patient-reported urgency in patients with severe overactive bladder (OAB) symptoms. AU - Serels,Scott R, AU - Toglia,Marc R, AU - Forero-Schwanhaeuser,Sergio, AU - He,Weizhong, PY - 2010/8/17/entrez PY - 2010/8/17/pubmed PY - 2011/2/10/medline SP - 2277 EP - 85 JF - Current medical research and opinion JO - Curr Med Res Opin VL - 26 IS - 10 N2 - OBJECTIVE: It is widely recognized that patient perception of overactive bladder (OAB) symptoms can vary considerably from mild to severe bother. This post hoc analysis reports outcomes in patients with severe OAB symptoms at baseline taken from the VESIcare Efficacy and Safety in PatieNts with Urgency Study (VENUS). METHODS: VENUS was a 12-week, randomized, double-blind, placebo-controlled trial of solifenacin (5 or 10 mg/day, flexibly dosed) in OAB patients. The primary endpoint in VENUS was mean change from baseline to study end in urgency episodes/day using 3-day bladder diaries. Secondary endpoints included other diary endpoints (frequency, incontinence, and nocturia), warning time (WT; time between first sensation of urgency to voiding), and patient-reported outcome (PRO) measures of urgency (the Indevus Urgency Severity Scale [IUSS] and Urgency Perception Scale [UPS]) and of symptom bother and health-related quality of life (HRQL) (the Patient Perception of Bladder Condition [PPBC] and Overactive Bladder Questionnaire). For this analysis, severe OAB was defined as baseline PPBC score ≥5 (1 = no problems, 6 = many severe problems). TRIAL REGISTRATION: NCT00454896. RESULTS: In total, 158/707 (22.3%) patients in the full analysis set (FAS) reported severe OAB symptoms. Solifenacin reduced mean urgency episodes/day versus placebo in the severe subgroup (-4.6 vs. -3.1, p = 0.1150), similar to the significant reduction observed in the FAS (-3.9 vs. -2.7, p < 0.0001). Solifenacin also improved the other diary endpoints and PRO measures in the severe subgroup; these changes were consistent with the significant solifenacin- versus placebo-related improvements for the FAS. Treatment-emergent adverse events were mostly mild/moderate, and few patients taking solifenacin or placebo discontinued treatment in the severe subgroup (4.5% vs. 6.5%) or FAS (6.5% vs. 4.6%). Key limitations are that VENUS was not powered to detect treatment differences in subgroups, and that the lack of a standardized definition of OAB symptom severity may limit the generalizability of the findings. CONCLUSIONS: Patients with severe OAB symptoms showed objective and subjective improvements in symptoms, symptom bother, HRQL, and urgency severity with solifenacin similar to the FAS. Solifenacin was also well-tolerated in this subgroup. SN - 1473-4877 UR - https://www.unboundmedicine.com/medline/citation/20707767/Impact_of_solifenacin_on_diary_recorded_and_patient_reported_urgency_in_patients_with_severe_overactive_bladder__OAB__symptoms_ DB - PRIME DP - Unbound Medicine ER -