Local Anesthetic Treatments for Overactive Bladder
- Registration Number
- NCT00427648
- Lead Sponsor
- Frank Tu
- 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 lidocaine may be effective in downregulating the afferent neuronal activity of a sensitized bladder, leading to elevation of the urge sensory threshold and decreasing detrusor activity. However, neither the effectiveness over placebo nor the durability of the response has been previously investigated.
Comparison(s): We propose a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized lidocaine instillation decreases symptoms of overactive bladder more than instillation of normal saline using a validated outcome instrument, the OAB-q.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 22
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 alkalinized xylocaine xylocaine 2 placebo normal saline
- Primary Outcome Measures
Name Time Method Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks. 6 weeks
- Secondary Outcome Measures
Name Time Method OAB-q (Symptom Scale) at 6 Weeks 6 weeks OAB-q SS is a 7 item overactive bladder symptom bother sub scale, ranging from 0-100, higher scores mean worse outcome for bother
Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only. 6 weeks This is based on retrograde infusion of sterile water into the bladder using a catheter, the maximum tolerated volume serving to define how much distension a woman can tolerate.
Median Number of Daily Voiding Episodes at 12 Months. 12 months SF-12 Physical at 6 Weeks 6 weeks SF-12 physical is an abbreviated version of the SF-36 a widely used, general health care quality of life instrument. Scores range from 0-100, and higher scores are better outcomes.
Global Assessment of Change - Frequency at 6 Weeks 6 weeks This is patient overall assessment of change in overactive bladder symptoms after treatment. 0% is no change, 100% is total resolution of symptoms
Average Weekly NRS for Frequency at 6 Weeks 6 weeks NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency
Trial Locations
- Locations (1)
NorthShore University HealthSystem
🇺🇸Park City, Illinois, United States