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

NCT00713921 | Withdrawn Early Phase 1 DMC FDA Drug

• 1 other identifier: 051008
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Urinary Incontinence; Bladder Dysfunction

Keywords

Female; Diabetics; Stroke

Outcome Measures

Primary Outcomes (1)

• Develop and quantify methods for evaluating bladder dysfunction in diabetes and stroke. Develop pilot data of medical therapy (Toviaz) in diabetic and stroke bladder dysfunction.

  Patients assessed by neurophysiologic and urologic assessment; develop study methods for evaluation; develop pilot data of medical therapy.

  18 months

Interventions

Fesoterodine Oral Product DRUG

After urological and neurological evaluation, those patients who meet he US approved indications for prescribing will be placed on a regimen of Toviaz 4 mg/day taken once daily with liquids and swallowed whole. The Toviaz dose may be increased to 8 mg/day if there is not therapeutic response on the 4 mg/day.

Also known as: Toviaz

Eligibility Criteria

• Age: 21 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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:
• Men
• Patients with cardiac pacemaker or other indwelling device that would preclude neurophysiologic testing;
• Patients with an indwelling urinary catheter that cannot be removed

Sponsors & Collaborators

• Saint Thomas Health: lead
• Pfizer: collaborator

Study Sites (1)

Vanderbilt Univiersity

Nashville, Tennessee, 37232-2519, United States

Location

MeSH Terms

Conditions

Urinary Incontinence; Stroke

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Barry K Jarnagin, MD

  Vanderbilt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 14, 2008
• Study Start: September 15, 2009
• Primary Completion: January 17, 2014
• Study Completion: January 17, 2014
• Last Updated: September 11, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)