Local Anesthetic Treatments for Overactive Bladder

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2010-05-31

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).

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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.

Conditions

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Overactive Bladder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

xylocaine

Group Type ACTIVE_COMPARATOR

alkalinized xylocaine

Intervention Type DRUG

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

2

normal saline

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

normal saline

Interventions

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alkalinized xylocaine

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

Intervention Type DRUG

placebo

normal saline

Intervention Type DRUG

Other Intervention Names

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normal saline

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No