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

• ClinicalTrials.gov Identifier: NCT01018264
• Recruitment Status: Completed
• First Posted: November 23, 2009
• Results First Posted: May 27, 2015
• Last Update Posted: November 9, 2021
• Sponsor: University of South Florida
• Information provided by (Responsible Party): Theresa Zesiewicz, MD, University of South Florida

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Overactive Bladder in Parkinson's Disease	Drug: solifenacin succinate (VESIcare); Drug: placebo	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 23 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, 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
• Study Start Date: January 2010
• Actual Primary Completion Date: August 2014
• Actual Study Completion Date: August 2014

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. Number of Micturations Per 24 Hour Period [ Time Frame: 12 weeks ]
   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.

Secondary Outcome Measures :

1. Number of Urinary Incontinence Episodes Per 24 Hour Period [ Time Frame: 12 weeks ]
   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.
2. Unified Parkinson's Disease Rating Scale (UPDRS) Total [ Time Frame: 12 weeks ]
   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).
3. Parkinson's Disease Quality of Life Scale (PDQOL) [ Time Frame: 12 weeks ]
   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.
4. Number of Nocturia Episodes Per 24 Hour Period [ Time Frame: 12 weeks ]
   To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity

Eligibility Criteria

• Ages Eligible for Study: 40 Years to 80 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Investigators

• Principal Investigator: Theresa Zesiewicz, MD; University of South Florida

More Information

• Responsible Party: Theresa Zesiewicz, MD, Professor of Neurology, University of South Florida
• ClinicalTrials.gov Identifier: NCT01018264
• Other Study ID Numbers: URGE-PD
• First Posted: November 23, 2009
• Results First Posted: May 27, 2015
• Last Update Posted: November 9, 2021
• Last Verified: November 2021

Keywords provided by Theresa Zesiewicz, MD, 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; Synucleinopathies; Neurodegenerative Diseases; Urinary Bladder Diseases; Urologic Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Solifenacin Succinate; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Urological Agents