Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients
Withdrawn before enrolling · Early Phase 1
Conditions studied: Urinary Incontinence, Bladder Dysfunction
In brief
Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke
Key facts
- Study ID
- NCT00713921
- Run by
- Saint Thomas Health
- People needed
- 0
- Starts
- 2009-09-15
- Expected to finish
- 2014-01-17
- Last updated by the study team
- 2018-09-11
Who can join
Age: 21 and older, up to 85. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
- Inclusion Criteria:
- 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
You may not qualify if…
- 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:
- Exclusion Criteria:
- 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 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, pelvic floor tumor, 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
- Pregnancy or actively seeking pregnancy
Where it is running
- Vanderbilt Univiersity — Nashville, Tennessee, United States
Full record on ClinicalTrials.gov
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