Status:
WITHDRAWN
Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients
Lead Sponsor:
Saint Thomas Health
Collaborating Sponsors:
Pfizer
Conditions:
Urinary Incontinence
Bladder Dysfunction
Eligibility:
FEMALE
21-85 years
Phase:
EARLY_PHASE1
Brief Summary
Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke
Detailed Description
1. Specific Aims: 1. To investigate clinical bladder dysfunction in a cohort of 10 diabetic and 10 stroke patients as assessed by a combined neurophysiologic and urologic assessment. 2. To deve...
Eligibility Criteria
Inclusion
- Stroke Population:
- Ischemic or hemorrhagic stroke in the anterior or posterior circulation within the past month in persons 21 years of age and over
- NIH Stroke Scale Score of 4 or greater one month post-stroke
- Modified Rankin Scale of 2 or greater
- Patients with motor or verbal impairment with surrogacy consent
- Diabetic Population:
- Clinically stable diabetes type 2 females 21 years of age or older
- Peripheral neuropathy associated with diabetes Dyck stage 2 or 3
- Clinical evaluation by neurologist reveals no other likely cause of neuropathy
Exclusion
- Stroke Population:
- Men
- Patients with cardiac pacemaker or other indwelling device that would preclude neurophysiologic testing;
- Patients with an indwelling urinary catheter that cannot be removed
- Patients who are on warfarin or similar anticoagulants that cannot be stopped for the study procedures
- Patients with a poor prognosis due to stroke or underlying illness who, it is anticipated, would be unable to participate for the period of the study
- Females with current pregnancy, multiparity \>/=4, prior pelvic floor dysfunction, or pelvic floor tumor. Women with incontinence prior to stroke, cystocele, rectocele, or urethral stricture
- Patients unable to tolerate Detrol LA; such patients would include those with significant renal or hepatic disease, those currently taking drugs metabolized by the cytochrome P450 enzyme system that might confound interpretation of responses ( Delaviridine, indinavir, nelfinavir, ritonavir, amiodarone, aprepitant, cimetidine, ciprofloxacin, clarithromycin, diltiazem, erythromycin, fluconazole, fluvoxamine, grapefruit juice, itraconazole, ketoconazole, mifepristone, nefazodone, norfloxacin, verapamil, efavirenz, nevirapine, carbamazepine, phenobarbital, phenyltoin, rifampin, St. John's wort, troglitazone, oxcarbazepine, pioglitazone, rifabutin); those with urinary retention, gastric retention, uncontrolled narrow angel glaucoma, or those with a known sensitivity to the drug or its ingredients
- Patients who have a history of diabetes
- Pregnancy or actively seeking pregnancy
- Patients who are cognitively impaired
- Diabetes Population:
Key Trial Info
Start Date :
September 15 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 17 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00713921
Start Date
September 15 2009
End Date
January 17 2014
Last Update
September 11 2018
Active Locations (1)
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1
Vanderbilt Univiersity
Nashville, Tennessee, United States, 37232-2519