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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 Saint Thomas Health Services, July 2008
First Received: July 9, 2008   Last Updated: January 27, 2009   History of Changes
Sponsors and Collaborators: Saint Thomas Hospital
Pfizer
Information provided by: Saint Thomas Health Services
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

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

Resource links provided by NLM:


Further study details as provided by Saint Thomas Health Services:

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
Saint Thomas Hospital
Pfizer
Investigators
Principal Investigator: Barry K Jarnagin, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Vanderbilt University ( Dr. Barry Jarnagin, Principal Investigator )
Study ID Numbers: 051008
Study First Received: July 9, 2008
Last Updated: January 27, 2009
ClinicalTrials.gov Identifier: NCT00713921     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Thomas Health Services:
Female
Diabetics
Stroke

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

Additional relevant MeSH terms:
Neurotransmitter Agents
Cholinergic Antagonists
Molecular Mechanisms of Pharmacological Action
Urination Disorders
Physiological Effects of Drugs
Cholinergic Agents
Pharmacologic Actions
Muscarinic Antagonists
Urological Manifestations
Signs and Symptoms
Urologic Diseases
Urinary Incontinence
Tolterodine

ClinicalTrials.gov processed this record on September 03, 2009