Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease

Study Overview
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Brief Summary
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This study will assess the effectiveness of solifenacin succinate (VESIcare) in reducing symptoms of overactive bladder in Parkinson's disease (PD) patients.

Official Title
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URGE-PD: A Multi-site, Double-blind, Randomized, Placebo Controlled Trial of Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease

Conditions
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Overactive Bladder in Parkinson's Disease

Intervention / Treatment
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* Drug: solifenacin succinate (VESIcare)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria. Age 40 years to 80 years. Stable dose of antiparkinsonian medication 4 weeks prior to study entry. Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale. Women of child-bearing potential must use a reliable method of contraception. Must be experiencing symptoms of overactive bladder according to the ICS definition of a minimum voiding 8 or more times/24 hours and a daily average of at least 1 episode of urgency and/or urinary incontinence (urge incontinence predominately as measured by 3IQ diary) per 24 hours during a 3-day micturition diary period. Patients must have documentation of OAB within the last 6 months. The patient must have evidence of PSA less than or equal to 4 (males only) within the last 12 months (obtained from primary care physician). The patient must have had a bladder scan within six months of the screening visit. This scan uses ultrasound technology to measure residual fluid levels in the bladder after urination. This scan must document post void residual of 200 mls or less. A bladder scan printout or a note documenting these findings must be provided before baseline. Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 months. Exclusion Criteria: Any illness that in the investigator's opinion preclude participation in this study. Pregnancy or lactation. Concurrent participation in another clinical study. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27). Legal incapacity or limited legal capacity. History of prostate cancer or Transurethral resection of the prostate (TURP) (males only). Presence of severe renal disease. BUN 50% greater than normal (normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L). Labs within the past 12 months will be requested from the patient's health care provider or urologist. If labs are not available within this time-frame or if results are abnormal, labs will be obtained as part of the screening visit. Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis). Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders. History of narrow angle glaucoma. Patients who have undergone pelvic radiation at any time. Currently taking any of the following medications: Antiarrhythmics: flecainide (Almarytm, Apocard, Ecrinal, Flécaine), digoxin (Lanoxin, Digitek, Lanoxicaps) Antipsychotics: thioridazine (Mellaril, Novorizadine, Thioril) Tricyclic anti-depressants: amitriptyline (Elavil, Tryptanol, Endep, Elatrol, Tryptizol, Trepiline, Laroxyl), amoxapine (Asendin, Asendis, Defanyl, Demolox, Moxadil), clomipramine (Anafranil), desipramine (Norpramin, Pertofrane), imipramine (Antideprin, Deprenil, Deprimin, Deprinol, Depsonil, Dynaprin, Eupramin, Imipramil, Irmin, Janimine, Melipramin, Surplix, Tofranil), nortriptyline (Aventyl, Pamelor, Nortrilen), protriptyline (Vivactil), trimipramine (Stangyl, Surmontil, Rhotrimine) Psychotropics: doxepin (Aponal, Adapine, Sinquan, Sinequan) Anticholinergics/Antispasmodics: trihexyphenidyl (Artane, Aparkan), benztropine (Cogentin), oxybutynin (Ditropan, Ditropan XL, Lyrinel XL, Oxytrol), darifenacin (Enablex), emepronium, flavoxate (Urispas), meladrazine, propiverine, solifenacin (Vesicare), tolterodine (Detrol, Detrol LA), trospium (Sanctura) Selective Serotonin-Norepinephrine Reuptake Inhibitors (SNRI): duloxetine (Cymbalta, Yentreve), Venlafaxine (Effexor, Effexor XR) Arylalkylamines: pseudoephedrine (Sudafed) Anti-androgen: bicalutamide (Casodex, Cosudex, Calutide, Kalumid), finasteride (Proscar, Propecia, Fincar, Finpecia, Finax, Finast, Finara, Finalo, Prosteride, Gefina, Finasterid IVAX), dutasteride (Avodart, Avidart, Avolve, Duagen, Dutas, Dutagen, Duprost), Zoladex (goserelin acetate), Eulexin (flutamide), Lupron (leuprolide acetate) Antihypertensives: prazosin (Minipress, Vasoflex, Hypovase) Estrogens (Menest, Premarin, Premarin IV) Acetylcholinesterase inhibitors (rivastigmine (Exelon), galantamine, (Reminyl, donepezil (Aricept), Tacrine. Memantine (Namenda) Urinary obstruction in male PD patients as diagnosed by a urologist Active urinary tract infection. Patients with a history of chronic severe constipation (by self report)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: solifenacin succinate (VESIcare)<br> | Drug: solifenacin succinate (VESIcare)<br>* up to 10mg every day orally<br>|
| Placebo Comparator: placebo<br> | Drug: placebo<br>* placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Micturations Per 24 Hour Period | The primary objective of this study is to measure the efficacy of solifenacin succinate (VESIcare) in reducing the mean number of micturitions per 24 hour period in Parkinson's disease (PD) patients as measured by voiding diaries. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Urinary Incontinence Episodes Per 24 Hour Period | This scale it the mean number of urinary incontinence episodes per 24 hour period, as assessed by a 3-day bladder diary. The goal is to examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity. | 12 weeks | 
| Unified Parkinson's Disease Rating Scale (UPDRS) Total | To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity. The UPDRS total score ranges from 0 (no disability) to 199 (total disability). | 12 weeks | 
| Parkinson's Disease Quality of Life Scale (PDQOL) | This scale is used to assess quality of life in Parkinson's Disease patients. Parkinson's disease quality of life scale has a possible point range from 37 (worst outcome) to 185 (best outcome). The goal of this outcome measure is to examine the effect of solifenacin succinate (VESIcare) on quality of life. | 12 weeks | 
| Number of Nocturia Episodes Per 24 Hour Period | To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Overactive bladder, Urinary incontinence, Urinary frequency, Parkinson's disease