Local Anesthetic Treatments for Overactive Bladder

Frank Tu

Status and phase: Terminated; Phase 3

Conditions: Overactive Bladder

Treatments: Drug: placebo; Drug: alkalinized xylocaine

Study type: Interventional

Funder types: Other

Identifiers

NCT00427648

EH 06-092

Details and patient eligibility

About

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

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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22 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

xylocaine

Treatment:

Drug: alkalinized xylocaine

2

Placebo Comparator group

Description:

normal saline

Treatment:

Drug: placebo