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

• Sponsor: University of South Florida (Other)
• Overall Status: Completed
• CT.gov ID: NCT01018264
• Collaborator: (none)
• Enrollment: 23
• Locations: 3
• Arms: 2
• Duration (Months): 55
• Patients Per Site: 7.7
• Patients Per Site Per Month: 0.1

Study Details

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
• 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: Jan 1, 2010
• Actual Primary Completion Date: Aug 1, 2014
• Actual Study Completion Date: Aug 1, 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 [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 [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 [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) [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 [12 weeks]

   To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

1. Urinary obstruction in male PD patients as diagnosed by a urologist

2. Active urinary tract infection.

3. Patients with a history of chronic severe constipation (by self report)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Miami	Miami	Florida	United States	33136
2	University of South Florida	Tampa	Florida	United States	33612
3	Emory University	Atlanta	Georgia	United States	30329

Sponsors and Collaborators

• University of South Florida

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Theresa Zesiewicz, MD, Professor of Neurology, University of South Florida
• ClinicalTrials.gov Identifier: NCT01018264
• Other Study ID Numbers: URGE-PD
• First Posted: Nov 23, 2009
• Last Update Posted: Nov 9, 2021
• Last Verified: Nov 1, 2021

• Keywords provided by Theresa Zesiewicz, MD, Professor of Neurology, University of South Florida: Overactive bladder; Urinary incontinence; Urinary frequency; Parkinson's disease
• Additional relevant MeSH terms: Parkinson Disease; Urinary Bladder, Overactive; Solifenacin Succinate

Study Results

Participant Flow

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Period Title: Overall Study
STARTED	10	13
COMPLETED	9	12
NOT COMPLETED	1	1

Baseline Characteristics

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo	Total
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day	Total of all reporting groups
Overall Participants	10	13	23
Age, Customized (years) [Mean (Standard Deviation) ]
Age (years)	67.6 (6.6)	66.5 (9.3)	66.96 (8.04)
Sex: Female, Male (Count of Participants)
Female	3 30%	5 38.5%	8 34.8%
Male	7 70%	8 61.5%	15 65.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 10%	1 7.7%	2 8.7%
Not Hispanic or Latino	9 90%	12 92.3%	21 91.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	1 7.7%	1 4.3%
Black or African American	1 10%	1 7.7%	2 8.7%
White	8 80%	10 76.9%	18 78.3%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	1 10%	1 7.7%	2 8.7%
Unified Parkinson's Disease Rating Scale (UPDRS) ADL subsection (mean) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	9.50 (5.40)	11.23 (4.76)	10.48 (5.01)
Unified Parkinson's Disease Rating Scale (UPDRS) Motor subsection (Part III) (points) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [points]	12.60 (4.38)	14.69 (5.19)	13.78 (4.86)
Unified Parkinson's Disease Rating Scale (UPDRS) Total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	24.00 (9.67)	25.08 (11.93)	24.61 (10.78)
Parkinson's Disease Quality of Life (PDQOL) total score (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	124.10 (19.96)	115.31 (10.68)	119.13 (15.65)
Hoehn & Yahr stage (participants) [Number]
Stage 1	1 10%	0 0%	1 4.3%
Stage 1.5	1 10%	1 7.7%	2 8.7%
Stage 2	1 10%	2 15.4%	3 13%
Stage 2.5	6 60%	7 53.8%	13 56.5%
Stage 3	1 10%	3 23.1%	4 17.4%
Incontinence Quality of Life scale (IQOL) (units on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [units on a scale]	78.00 (20.03)	75.92 (18.87)	76.83 (18.96)
Bladder diary: # micturations (Micturation episodes per 24 hour period) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Micturation episodes per 24 hour period]	9.03 (2.21)	9.23 (3.31)	9.14 (2.83)
Bladder diary: # leaks (Number of leaks per 24-hour period) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of leaks per 24-hour period]	1.33 (2.45)	1.72 (1.23)	1.55 (1.82)
Bladder diary: # nocturia episodes (Number of nocturia episodes per 24 hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Number of nocturia episodes per 24 hours]	2.23 (1.69)	1.90 (1.09)	2.04 (1.36)
Patient perception of Bladder Condition (PBC/PPBC) (participants) [Number]
Causes me (some) moderate problems	5 50%	5 38.5%	10 43.5%
Causes me severe problems	4 40%	7 53.8%	11 47.8%
Causes me many severe problems	1 10%	1 7.7%	2 8.7%
Patient Perception of Intensity of Urgency Scale (PPIUS) (participants) [Number]
Mild Urgency	3 30%	1 7.7%	4 17.4%
Moderate Urgency	4 40%	5 38.5%	9 39.1%
Moderate-Severe	0 0%	1 7.7%	1 4.3%
Severe Urgency	3 30%	6 46.2%	9 39.1%

Outcome Measures

1. Primary Outcome

Title	Number of Micturations Per 24 Hour Period
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Measure Participants	9	12
Baseline	8.78 (2.18)	9.19 (3.46)
Endpoint (12 weeks)	8.00 (3.36)	8.94 (3.06)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin Succinate (VESIcare), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.53
	Comments
	Method	ANCOVA
	Comments	Adjusted for baseline value
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.20
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments	This represents the effect size between solifenacin and placebo.

2. Secondary Outcome

Title	Number of Urinary Incontinence Episodes Per 24 Hour Period
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Measure Participants	9	12
Baseline	1.48 (2.56)	1.78 (1.27)
Endpoint (12 weeks)	0.30 (0.31)	1.61 (1.40)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin Succinate (VESIcare), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.53
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

3. Secondary Outcome

Title	Unified Parkinson's Disease Rating Scale (UPDRS) Total
Description	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).
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Measure Participants	9	12
Baseline	25.00 (9.70)	25.67 (12.26)
Endpoint (12 weeks)	21.67 (9.59)	25.75 (8.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin Succinate (VESIcare), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.22
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.35
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

4. Secondary Outcome

Title	Parkinson's Disease Quality of Life Scale (PDQOL)
Description	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.
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Measure Participants	9	12
Baseline	125.00 (20.95)	114.50 (10.73)
Endpoint (12 weeks)	116.00 (26.42)	112.92 (17.19)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin Succinate (VESIcare), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.47
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.27
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

5. Secondary Outcome

Title	Number of Nocturia Episodes Per 24 Hour Period
Description	To examine the effect of solifenacin succinate (VESIcare) on urinary incontinence severity
Time Frame	12 weeks

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Solifenacin Succinate (VESIcare)	Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally	placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
Measure Participants	9	12
Baseline	2.48 (1.59)	1.92 (1.14)
Endpoint (12 weeks)	2.04 (1.96)	1.78 (0.88)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Solifenacin Succinate (VESIcare), Placebo
	Comments
	Type of Statistical Test	Superiority or Other (legacy)
	Comments
Statistical Test of Hypothesis	p-Value	0.94
	Comments
	Method	ANCOVA
	Comments
Method of Estimation	Estimation Parameter	Effect size
	Estimated Value	0.11
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Arm/Group Title	Solifenacin Succinate (VESIcare)		Placebo
Arm/Group Description	solifenacin succinate (VESIcare): up to 10mg every day orally		placebo: placebo matching solifenacin succinate (VESIcare) up to 10mg orally every day
All Cause Mortality
	Solifenacin Succinate (VESIcare)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Solifenacin Succinate (VESIcare)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/10 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Solifenacin Succinate (VESIcare)		Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/10 (40%)		0/13 (0%)
Gastrointestinal disorders
Constipation	1/10 (10%)	1	0/13 (0%)	0
Renal and urinary disorders
urinary retention	1/10 (10%)	1	0/13 (0%)	0
Skin and subcutaneous tissue disorders
Xerostomia	2/10 (20%)	2	0/13 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.