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Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients
This study is currently recruiting participants.
Verified by Vanderbilt University, July 2008
Sponsors and Collaborators: Vanderbilt University
Pfizer
Information provided by: Vanderbilt University
ClinicalTrials.gov Identifier: NCT00713921
  Purpose

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


Condition Intervention
Urinary Incontinence
Bladder Dysfunction
Drug: Detrol LA

MedlinePlus related topics: Diabetes Urinary Incontinence
Drug Information available for: Tolterodine Tolterodine tartrate
U.S. FDA Resources
Study Type: Interventional
Study Design: Diagnostic, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title: Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients

Further study details as provided by Vanderbilt University:

Primary Outcome 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: February 2008
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental Drug: Detrol LA
Oral Detrol LA, 4mg daily for sim months

  Eligibility

Ages Eligible for Study:   21 Years to 85 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00713921

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

Locations
United States, Tennessee
Vanderbilt Univiersity Recruiting
Nashville, Tennessee, United States, 37232-2519
Contact: Lynne Black     615-343-9933        
Principal Investigator: Barry Jarnagin            
Sponsors and Collaborators
Vanderbilt University
Pfizer
Investigators
Principal Investigator: Barry K Jarnagin, MD Vanderbilt University
  More Information

Responsible Party: Vanderbilt University ( Dr. Barry Jarnagin, Principal Investigator )
Study ID Numbers: 051008
Study First Received: July 9, 2008
Last Updated: July 11, 2008
ClinicalTrials.gov Identifier: NCT00713921  
Health Authority: United States: Institutional Review Board

Keywords provided by Vanderbilt University:
Female
Diabetics
Stroke

Study placed in the following topic categories:
Signs and Symptoms
Urologic Diseases
Cerebral Infarction
Urination Disorders
Stroke
Diabetes Mellitus
Urinary Incontinence
Tolterodine

Additional relevant MeSH terms:
Muscarinic Antagonists
Urological Manifestations
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 14, 2009