Local Anesthetic Treatments for Overactive Bladder

Phase 3TerminatedNCT00427648

Frank Tu22 enrolled

Overview

The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Overactive Bladder

Interventions

alkalinized xylocaineDRUG

30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks

placeboDRUG

normal saline

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (2)

NorthShore University HealthSystem

Evanston, Illinois, United States

NorthShore University HealthSystem

Park City, Illinois, United States

Outcomes

Primary Outcomes

Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.

Time frame: 6 weeks

Secondary Outcomes

Median Number of Daily Voiding Episodes at 12 Months.

Time frame: 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.

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: 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.

Time frame: 6 weeks

Data from ClinicalTrials.gov

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