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

• Register: ClinicalTrials.gov
• Last refreshed on: 22 November 2021
• Main ID: NCT01018264
• Date of registration: 19/11/2009
• Prospective Registration: Yes
• Primary sponsor: University of South Florida
• Public title: Solifenacin Succinate (VESIcare) for the Treatment of Overactive Bladder in Parkinson's Disease URGE-PD
• Scientific 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
• Date of first enrolment: January 2010
• Target sample size: 23
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01018264
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

United States

Contacts

• Name: Theresa Zesiewicz, MD
• Affiliation: University of South Florida

Key inclusion & exclusion 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)



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Overactive Bladder in Parkinson's Disease

Intervention(s)

Drug: placebo

Drug: solifenacin succinate (VESIcare)

Primary Outcome(s)

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

Secondary Outcome(s)

Number of Urinary Incontinence Episodes Per 24 Hour Period [Time Frame: 12 weeks]

Unified Parkinson's Disease Rating Scale (UPDRS) Total [Time Frame: 12 weeks]

Number of Nocturia Episodes Per 24 Hour Period [Time Frame: 12 weeks]

Parkinson's Disease Quality of Life Scale (PDQOL) [Time Frame: 12 weeks]

Secondary ID(s)

URGE-PD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/05/2015
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01018264