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Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder.
Neurourol Urodyn. 2011 Nov; 30(8):1480-5.NU

Abstract

AIMS

To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study.

METHODS

Subjects were randomized to fesoterodine 4 mg or placebo. At week 2, subjects could remain on 4 mg (non-escalators) or choose to increase to 8 mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3-day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes.

RESULTS

Sixty-three per cent of 438 subjects randomized to fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, fesoterodine escalators had significantly more micturitions and urgency episodes than fesoterodine non-escalators (P < 0.001); at week 2, before dose escalation, diary-dry rate and improvement in micturitions and urgency episodes were significantly greater among fesoterodine non-escalators versus escalators (P < 0.001); and by week 12, after dose escalation, diary-dry rate and improvements in micturitions and UUI episodes were similar between fesoterodine non-escalators and escalators (P > 0.05). The placebo escalator group did not demonstrate a similar response over placebo non-escalators following the dose escalation decision point.

CONCLUSION

A rapid and robust response to fesoterodine 4 mg was demonstrated in non-escalators. Subjects who chose to dose escalate to fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose.

Authors+Show Affiliations

St. Elizabeth's Medical Center, Tufts University School of Medicine, Boston, Massachusetts 02135, USA. dstaskin@gmail.comNo affiliation info availableNo affiliation info availableNo affiliation info availableNo 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

21560158

Citation

Staskin, David, et al. "Effects of Voluntary Dose Escalation in a Placebo-controlled, Flexible-dose Trial of Fesoterodine in Subjects With Overactive Bladder." Neurourology and Urodynamics, vol. 30, no. 8, 2011, pp. 1480-5.
Staskin D, Khullar V, Michel MC, et al. Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder. Neurourol Urodyn. 2011;30(8):1480-5.
Staskin, D., Khullar, V., Michel, M. C., Morrow, J. D., Sun, F., Guan, Z., & Dmochowski, R. (2011). Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder. Neurourology and Urodynamics, 30(8), 1480-5. https://doi.org/10.1002/nau.21099
Staskin D, et al. Effects of Voluntary Dose Escalation in a Placebo-controlled, Flexible-dose Trial of Fesoterodine in Subjects With Overactive Bladder. Neurourol Urodyn. 2011;30(8):1480-5. PubMed PMID: 21560158.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder. AU - Staskin,David, AU - Khullar,Vik, AU - Michel,Martin C, AU - Morrow,Jon D, AU - Sun,Franklin, AU - Guan,Zhonghong, AU - Dmochowski,Roger, Y1 - 2011/05/10/ PY - 2010/12/15/received PY - 2011/02/09/accepted PY - 2011/5/12/entrez PY - 2011/5/12/pubmed PY - 2012/2/11/medline SP - 1480 EP - 5 JF - Neurourology and urodynamics JO - Neurourol Urodyn VL - 30 IS - 8 N2 - AIMS: To characterize the response to fesoterodine treatment for overactive bladder (OAB) in subjects who did or did not choose to dose escalate in a flexible-dose study. METHODS: Subjects were randomized to fesoterodine 4 mg or placebo. At week 2, subjects could remain on 4 mg (non-escalators) or choose to increase to 8 mg (escalators) for the remaining 10 weeks (sham escalation for placebo). Subjects completed 3-day bladder diaries at baseline, week 2 and week 12 noting micturitions, urgency episodes, and urgency urinary incontinence (UUI) episodes. RESULTS: Sixty-three per cent of 438 subjects randomized to fesoterodine and 73% of 445 randomized to placebo dose escalated. At baseline, fesoterodine escalators had significantly more micturitions and urgency episodes than fesoterodine non-escalators (P < 0.001); at week 2, before dose escalation, diary-dry rate and improvement in micturitions and urgency episodes were significantly greater among fesoterodine non-escalators versus escalators (P < 0.001); and by week 12, after dose escalation, diary-dry rate and improvements in micturitions and UUI episodes were similar between fesoterodine non-escalators and escalators (P > 0.05). The placebo escalator group did not demonstrate a similar response over placebo non-escalators following the dose escalation decision point. CONCLUSION: A rapid and robust response to fesoterodine 4 mg was demonstrated in non-escalators. Subjects who chose to dose escalate to fesoterodine 8 mg at week 2 showed significant improvement by week 12 versus baseline and week 2 (prior to escalation), as well as versus placebo. Dose escalation to 8 mg fesoterodine provided subjects with efficacy and tolerability similar to those who were satisfied with the 4-mg dose. SN - 1520-6777 UR - https://www.unboundmedicine.com/medline/citation/21560158/Effects_of_voluntary_dose_escalation_in_a_placebo_controlled_flexible_dose_trial_of_fesoterodine_in_subjects_with_overactive_bladder_ L2 - https://doi.org/10.1002/nau.21099 DB - PRIME DP - Unbound Medicine ER -