Official Title: “Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients”

Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke

Study Type: Interventional

Study Design: Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2008

Intervention(s) in this Clinical Trial

• Drug: Detrol LA
  • Oral Detrol LA, 4mg daily for sim months

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke

  . Develop pilot data of medical therapy (Detrol LA) in diabetic and stroke bladder dysfunction.
  • Time Frame: 18 months
    Safety Issue?: No

Inclusion Criteria:

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

Exclusion Criteria:

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 21 Years

Maximum Age for this Clinical Trial: 85 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Vanderbilt University

Overall Clinical Trial Officials and Contacts

Barry K Jarnagin, MD Principal Investigator Vanderbilt University  

Overall Contact: Barry K Jarnagin, MD 615-771-7580 barry.jarnagin@vanderbilt.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00713921

Study ID Number: 051008

ClinicalTrials.gov Identifier: NCT00713921

Health Authority: United States: Institutional Review Board