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

NCT ID: NCT01018264

Last Updated: 2021-11-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2014-08-31

Brief Summary

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

Conditions

Overactive Bladder in Parkinson's Disease

Keywords

Overactive bladder; Urinary incontinence; Urinary frequency; Parkinson's disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

solifenacin succinate (VESIcare)

Group Type: EXPERIMENTAL

solifenacin succinate (VESIcare)

Intervention Type: DRUG

up to 10mg every day orally

placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

Interventions

solifenacin succinate (VESIcare)

up to 10mg every day orally

Intervention Type: DRUG

placebo

placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day

Intervention Type: DRUG

Eligibility 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)

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Theresa Zesiewicz, MD

Professor of Neurology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Theresa Zesiewicz, MD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Locations

University of South Florida

Tampa, Florida, United States

Emory University

Atlanta, Georgia, United States

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

URGE-PD

Identifier Type: -

Identifier Source: org_study_id