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

Information source: Saint Thomas Health Services
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Urinary Incontinence; Bladder Dysfunction

Intervention: Detrol LA (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Saint Thomas Health Services

Official(s) and/or principal investigator(s):
Barry K Jarnagin, MD, Principal Investigator, Affiliation: Vanderbilt University

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

Summary

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

Clinical Details

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

Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Primary outcome: 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.

Eligibility

Minimum age: 21 Years. Maximum age: 85 Years. Gender(s): Female.

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

Locations and Contacts

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

Vanderbilt Univiersity, Nashville, Tennessee 37232-2519, United States; Recruiting
Lynne Black, Phone: 615-343-9933
Barry Jarnagin, Principal Investigator
Additional Information

Starting date: February 2008
Last updated: December 11, 2012

Page last updated: August 23, 2015

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