Fesoterodine on Urgency Episodes in Parkinson's Disease Population

Summary

Parkinson's disease (PD) causes several non-motor autonomic symptoms including lower urinary tract dysfunction. Their symptoms can be managed with antimuscarinics with variable efficacy. Fesoterodine offers a new therapeutic molecule to target the symptoms of urinary frequency, urgency and nocturia in this patient population. The purpose of this protocol is to compare the impact of fesoterodine to placebo on urinary urgency and nocturnal sleep problems in a heterogeneous population of PD patients in a cross-over fashion. A representative number of patients with baseline overactive bladder (OAB) symptoms and Parkinson's disease will be recruited to receive either the active drug or placebo for the first phase of eight weeks. The groups will then be crossed-over during the second phase of eight weeks. The main outcomes assessed will be the urgency episodes on a 3-day voiding diary, as well as the nocturnal sleep problems will be the Parkinson's Disease Sleep Scale (PDSS).

Timeline

Start

2016-09

Primary completion

2019-06-07

Completion

2019-06-07

Publications

• Background Winge K, Skau AM, Stimpel H, Nielsen KK, Werdelin L. Prevalence of bladder dysfunction in Parkinsons disease. Neurourol Urodyn. 2006;25(2):116-22. doi: 10.1002/nau.20193.
• Background Campeau L, Soler R, Andersson KE. Bladder dysfunction and parkinsonism: current pathophysiological understanding and management strategies. Curr Urol Rep. 2011 Dec;12(6):396-403. doi: 10.1007/s11934-011-0219-8.
• Background Katzenschlager R, Sampaio C, Costa J, Lees A. Anticholinergics for symptomatic management of Parkinson's disease. Cochrane Database Syst Rev. 2003;2002(2):CD003735. doi: 10.1002/14651858.CD003735.
• Background Donnellan CA, Fook L, McDonald P, Playfer JR. Oxybutynin and cognitive dysfunction. BMJ. 1997 Nov 22;315(7119):1363-4. doi: 10.1136/bmj.315.7119.1363. No abstract available.
• Background Hoyles K, Sharma JC. Olfactory loss as a supporting feature in the diagnosis of Parkinson's disease: a pragmatic approach. J Neurol. 2013 Dec;260(12):2951-8. doi: 10.1007/s00415-013-6848-8. Epub 2013 Feb 3.
• Background Wagg A, Dale M, Tretter R, Stow B, Compion G. Randomised, multicentre, placebo-controlled, double-blind crossover study investigating the effect of solifenacin and oxybutynin in elderly people with mild cognitive impairment: the SENIOR study. Eur Urol. 2013 Jul;64(1):74-81. doi: 10.1016/j.eururo.2013.01.002. Epub 2013 Jan 11.
• Background Abrams P, Cardozo L, Chapple C, Serdarevic D, Hargreaves K, Khullar V; 1032 Study Group. Comparison of the efficacy, safety, and tolerability of propiverine and oxybutynin for the treatment of overactive bladder syndrome. Int J Urol. 2006 Jun;13(6):692-8. doi: 10.1111/j.1442-2042.2006.01387.x.
• Background Zinner N, Tuttle J, Marks L. Efficacy and tolerability of darifenacin, a muscarinic M3 selective receptor antagonist (M3 SRA), compared with oxybutynin in the treatment of patients with overactive bladder. World J Urol. 2005 Sep;23(4):248-52. doi: 10.1007/s00345-005-0507-3. Epub 2005 Nov 8.
• Background Vecchioli-Scaldazza C, Morosetti C, Berouz A, Giannubilo W, Ferrara V. Solifenacin succinate versus percutaneous tibial nerve stimulation in women with overactive bladder syndrome: results of a randomized controlled crossover study. Gynecol Obstet Invest. 2013;75(4):230-4. doi: 10.1159/000350216. Epub 2013 Mar 28.
• Background Chaudhuri KR, Pal S, DiMarco A, Whately-Smith C, Bridgman K, Mathew R, Pezzela FR, Forbes A, Hogl B, Trenkwalder C. The Parkinson's disease sleep scale: a new instrument for assessing sleep and nocturnal disability in Parkinson's disease. J Neurol Neurosurg Psychiatry. 2002 Dec;73(6):629-35. doi: 10.1136/jnnp.73.6.629.
• Background Ginsberg D, Schneider T, Kelleher C, Van Kerrebroeck P, Swift S, Creanga D, Martire DL. Efficacy of fesoterodine compared with extended-release tolterodine in men and women with overactive bladder. BJU Int. 2013 Aug;112(3):373-85. doi: 10.1111/bju.12174.
• Background Coyne KS, Matza LS, Kopp Z, Abrams P. The validation of the patient perception of bladder condition (PPBC): a single-item global measure for patients with overactive bladder. Eur Urol. 2006 Jun;49(6):1079-86. doi: 10.1016/j.eururo.2006.01.007. Epub 2006 Jan 24.
• Background Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74. doi: 10.1023/a:1016370925601.
• Background Cardozo L, Coyne KS, Versi E. Validation of the urgency perception scale. BJU Int. 2005 Mar;95(4):591-6. doi: 10.1111/j.1464-410X.2005.05345.x.

Drugs

Indications