Local Anesthetic Treatments for Overactive Bladder

Study Overview
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Brief Summary
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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
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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.

Official Title
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Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: alkalinized xylocaine
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>xylocaine | Drug: alkalinized xylocaine<br>* 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks<br>|
| Placebo Comparator: 2<br>normal saline | Drug: placebo<br>* normal saline<br>* Other names: normal saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks. |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median Number of Daily Voiding Episodes at 12 Months. |  | 12 months | 
| SF-12 Physical at 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. | 6 weeks | 
| OAB-q (Symptom Scale) at 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 | 6 weeks | 
| Global Assessment of Change - Frequency at 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 | 6 weeks | 
| Average Weekly NRS for Frequency at 6 Weeks | NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency | 6 weeks | 
| Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only. | 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. | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anesthetics, Local, Administration, Intravesical