Status:
TERMINATED
Local Anesthetic Treatments for Overactive Bladder
Lead Sponsor:
Frank Tu
Collaborating Sponsors:
Berlex Foundation
Conditions:
Overactive Bladder
Eligibility:
FEMALE
18-100 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).
Detailed Description
Existing first-line treatments for overactive bladder are limited by requirements for chronic dosing and associated systemic side effects. Small case series suggest that bladder instillation of lidoca...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Female patient, 18 years of age and older
- Overactive bladder defined as:
- Urinary frequency defined as eight or more voids in a 24 hour period \> 50% of days of the week
- Symptoms of urgency
- Symptoms of at least three months duration
- Exclusion criteria:
- Positive urine culture in the past month, or more than 3 episodes of bladder infection in the last 2 months
- Stress or overflow urinary incontinence (determined by clinician) if more than 14 episodes of urinary incontinence per week; also insensate incontinence
- Pregnancy
- Seizure disorder or clinically significant renal disease, allergy to lidocaine, uninvestigated hematuria, or history of urinary/reproductive tract malignancy
- Post-void residual more than 200 cc
Exclusion
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT00427648
Start Date
March 1 2006
End Date
May 1 2010
Last Update
March 6 2020
Active Locations (2)
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1
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
2
NorthShore University HealthSystem
Park City, Illinois, United States, 60085