Effects of voluntary dose escalation in a placebo-controlled, flexible-dose trial of fesoterodine in subjects with overactive bladder

Neurourology and Urodynamics

Volumn 30, Issue 8, 2011, Pages 1480-1485

  Staskin, David ^a   Khullar, Vik ^b   Michel, Martin C ^c   Morrow, Jon D ^d   Sun, Franklin ^e   Guan, Zhonghong ^e   Dmochowski, Roger ^f  

^a TUFTS UNIVERSITY SCHOOL OF MEDICINE   (United States)

^b ST MARY S HOSPITAL   (United Kingdom)

^c UNIVERSITY OF AMSTERDAM   (Netherlands)

^d MOUNT SINAI SCHOOL OF MEDICINE   (United States)

^e PFIZER INC   (United States)

^f VANDERBILT UNIVERSITY   (United States)

Author keywords

antimuscarinic; dose adjustment; efficacy; flexible dose; patient reported outcomes; quality of life; safety

Indexed keywords

FESOTERODINE; PLACEBO;

ADULT; AGED; ARTICLE; CONSTIPATION; CONTROLLED STUDY; DOUBLE BLIND PROCEDURE; DRUG DOSE ESCALATION; DRUG EFFICACY; DRUG TOLERABILITY; FEMALE; HEADACHE; HUMAN; MAJOR CLINICAL STUDY; MALE; MICTURITION; MORNING DOSAGE; OVERACTIVE BLADDER; RANDOMIZED CONTROLLED TRIAL (TOPIC); SHAM PROCEDURE; TREATMENT RESPONSE; URINARY URGENCY; URINE INCONTINENCE; XEROSTOMIA;

ADULT; AGED; AGED, 80 AND OVER; ANALYSIS OF VARIANCE; BENZHYDRYL COMPOUNDS; DOUBLE-BLIND METHOD; FEMALE; HUMANS; LOGISTIC MODELS; MALE; MIDDLE AGED; MUSCARINIC ANTAGONISTS; PLACEBOS; TIME FACTORS; TREATMENT OUTCOME; URINARY BLADDER; URINARY BLADDER, OVERACTIVE; URINARY INCONTINENCE; URINATION; URODYNAMICS; YOUNG ADULT;

EID: 80054812514     PISSN: 07332467     EISSN: 15206777     Source Type: Journal    
DOI: 10.1002/nau.21099     Document Type: Article

References (21)

1. Andersson KE, Chapple CR, Cardozo L, et al. Pharmacological treatment of overactive bladder: report from the International Consultation on Incontinence. Curr Opin Urol 2009; 19: 380-94.
2. Chapple CR, Khullar V, Gabriel Z, et al. The effects of antimuscarinic treatments in overactive bladder: an update of a systematic review and meta-analysis. Eur Urol 2008; 54: 543-62.
3. Khullar V, Chapple C, Gabriel Z, et al. The effects of antimuscarinics on health-related quality of life in overactive bladder: a systematic review and meta-analysis. Urology 2006; 68: 38-48.
4. Carr LK,. Overactive bladder. Can J Urol 2008; 15: 32-6 (discussion 36).
5. Benner JS, Nichol MB, Rovner ES, et al. Patient-reported reasons for discontinuing overactive bladder medication. BJU Int 2010; 105: 1276-82.
6. Chapple CR, Rosenberg MT, Brenes FJ,. Listening to the patient: a flexible approach to the use of antimuscarinic agents in overactive bladder syndrome. BJU Int 2009; 104: 960-7.
7. Toviaz (fesoterodine). Full prescribing information. New York, NY: Pfizer Inc.; 2008.
8. Chapple C, Van Kerrebroeck P, Tubaro A, et al. Clinical efficacy, safety, and tolerability of once-daily fesoterodine in subjects with overactive bladder. Eur Urol 2007; 52: 1204-12.
9. Nitti VW, Dmochowski R, Sand PK, et al. Efficacy, safety and tolerability of fesoterodine for overactive bladder syndrome. J Urol 2007; 178: 2488-94.
10. Khullar V, Rovner ES, Dmochowski R, et al. Fesoterodine dose response in subjects with overactive bladder syndrome. Urology 2008; 71: 839-43.
11. Wyndaele JJ, Goldfischer ER, Morrow JD, et al. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract 2009; 63: 560-7.
12. Dmochowski RR, Peters KM, Morrow JD, et al. Randomized, double-blind, placebo-controlled trial of flexible-dose fesoterodine in subjects with overactive bladder. Urology 2010; 75: 62-8.
13. Coyne KS, Matza LS, Kopp Z, et al. The validation of the Patient Perception of Bladder Condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol 2006; 49: 1079-86.
14. Coyne KS, Margolis MK, Hsieh R, et al. Validation of the urinary sensation scale (USS). Neurourol Urodyn 2011 (Epub ahead of print). DOI: 1111/j.1742-1241.2010.02489.x.
15. Staskin D, Michel MC, Morrow JD,. Interaction between placebo response and subjects' decision to dose escalate in a trial of flexible-dose antimuscarinic treatment for overactive bladder symptoms. Presented at: Joint Meeting of the International Continence Society/International Urogynecological Association; August 23-27, 2010; Toronto, Ontario, Canada.
16. Wyndaele JJ, Goldfischer ER, Morrow JD, et al. Patient-optimized doses of fesoterodine improve bladder symptoms in an open-label, flexible-dose study. BJU Int 2011; 107: 603-11.
17. Steers W, Corcos J, Foote J, et al. An investigation of dose titration with darifenacin, an M-selective receptor antagonist. BJU Int 2005; 95: 580-6.
18. van Leeuwen JHS, Castro R, Busse M, et al. The placebo effect in the pharmacologic treatment of patients with lower urinary tract symptoms. Eur Urol 2006; 50: 440-53.
19. Lee S, Malhotra B, Creanga D, et al. A meta-analysis of the placebo response in antimuscarinic drug trials for overactive bladder. BMC Med Res Methodol 2009; 9: 55.
20. Malhotra B, Darsey E, Crownover P, et al. Comparison of pharmacokinetic variability of fesoterodine vs tolterodine extended release in cytochrome P450 2D6 extensive and poor metabolizers. Br J Clin Pharmacol (Accepted article). 2011 DOI: 10.1111/1365-2125.2011.03948.x
21. Michel MC, Barendrecht MM,. Physiological and pathological regulation of the autonomic control of urinary bladder contractility. Pharmacol Ther 2008; 117: 297-312.