Neuropathic Investigation and Anticholinergic Treatment of Bladder Dysfunction in Diabetes and Stroke Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Saint Thomas Health Services
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Saint Thomas Health Services
ClinicalTrials.gov Identifier:
NCT00713921
First received: July 9, 2008
Last updated: December 11, 2012
Last verified: December 2012
  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: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
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: August 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Detrol LA
Oral Detrol LA, 4mg daily for sim months
Other Name: Detrol LA

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Health Services
Pfizer
Investigators
Principal Investigator: Barry K Jarnagin, MD Vanderbilt University
  More Information

No publications provided

Responsible Party: Saint Thomas Health Services
ClinicalTrials.gov Identifier: NCT00713921     History of Changes
Other Study ID Numbers: 051008
Study First Received: July 9, 2008
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Saint Thomas Health Services:
Female
Diabetics
Stroke

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

ClinicalTrials.gov processed this record on July 29, 2014