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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Astellas Pharma Inc
Information provided by (Responsible Party):
Theresa Zesiewicz, University of South Florida
ClinicalTrials.gov Identifier:
NCT01018264
First received: November 19, 2009
Last updated: June 27, 2014
Last verified: June 2014
  Purpose

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


Condition Intervention Phase
Overactive Bladder in Parkinson's Disease
Drug: solifenacin succinate (VESIcare)
Drug: placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • 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. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To examine the effect of solifenacin succinate (VESIcare) on Parkinson's disease severity [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • To examine the effect of solifenacin succinate (VESIcare) on quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: solifenacin succinate (VESIcare) Drug: solifenacin succinate (VESIcare)
up to 10mg every day orally
Placebo Comparator: placebo Drug: placebo
placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Outpatients with idiopathic PD according to the UK Parkinson's Disease Society Brain Bank Clinical Diagnosis Criteria.
  2. Age 40 years to 80 years.
  3. Stable dose of antiparkinsonian medication 4 weeks prior to study entry.
  4. Patients must score 1.0 to 3.0 on the Modified Hoehn and Yahr scale.
  5. Women of child-bearing potential must use a reliable method of contraception.
  6. 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.
  7. 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).
  8. 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.
  9. Clearance from the patient's internist or primary care health provider who has examined the patient within the last 6 months.

Exclusion Criteria:

  1. Any illness that in the investigator's opinion preclude participation in this study.
  2. Pregnancy or lactation.
  3. Concurrent participation in another clinical study.
  4. Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam scores less than 27).
  5. Legal incapacity or limited legal capacity.
  6. History of prostate cancer or Transurethral resection of the prostate (TURP) (males only).
  7. 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.
  8. Presence of major hepatic impairment (cirrhosis, viral hepatitis, nonalcoholic steatohepatitis, Wilson's disease, or Hemochromotosis).
  9. Currently taking ketaconazole (anti-fungal) or any CYP3A4 inhibitor such as itraconazole, ritonavir, nelfinavir, clarithromycin, or nefazadone.
  10. Any history of bladder outflow obstruction or gastrointestinal obstructive disorders.
  11. History of narrow angle glaucoma.
  12. Patients who have undergone pelvic radiation at any time.
  13. 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)
  14. Urinary obstruction in male PD patients as diagnosed by a urologist
  15. Active urinary tract infection.
  16. Patients with a history of chronic severe constipation (by self report)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01018264

Locations
United States, Florida
University of Miami
Miami, Florida, United States, 33136
University of South Florida
Tampa, Florida, United States, 33612
United States, Georgia
Emory University
Atlanta, Georgia, United States, 30329
Sponsors and Collaborators
University of South Florida
Astellas Pharma Inc
Investigators
Principal Investigator: Theresa Zesiewicz, MD University of South Florida
Principal Investigator: Marian Evatt, MD Emory University
Principal Investigator: Carlos Singer, MD University of Miami
  More Information

No publications provided

Responsible Party: Theresa Zesiewicz, Professor of Neurology, University of South Florida
ClinicalTrials.gov Identifier: NCT01018264     History of Changes
Other Study ID Numbers: Sullivan-9
Study First Received: November 19, 2009
Last Updated: June 27, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of South Florida:
Overactive bladder
Urinary incontinence
Urinary frequency
Parkinson's disease

Additional relevant MeSH terms:
Parkinson Disease
Urinary Bladder, Overactive
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Quinuclidin-3'-yl-1-phenyl-1,2,3,4-tetrahydroisoquinoline-2-carboxylate monosuccinate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 10, 2014