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

• Status: Withdrawn
• Trial end date: 2014-01-17
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Saint Thomas Health; Saint Thomas Health Services
• Collaborator: Pfizer
• Treatments: Cholinergic Antagonists; Fesoterodine; Tolterodine Tartrate

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