Local Anesthetic Treatments for Overactive Bladder

• Mean number of daily voiding episodes at 3, 6, and 12 months. [ Time Frame: 3, 6, 12 months ] [ Designated as safety issue: No ]
• SF-12 at 6 weeks, and 3, 6, and 12 months. [ Time Frame: 6 weeks and 3, 6, and 12 months ] [ Designated as safety issue: No ]
• OAB-q at 6 weeks, and 3, 6, and 12 months. [ Time Frame: 6 weeks and 3, 6, and 12 months ] [ Designated as safety issue: No ]
• Global assessment of change - urgency/frequency at 6 weeks, and 3, 6, and 12 months. [ Time Frame: 6 weeks, and 3, 6, and 12 months ] [ Designated as safety issue: No ]
• Average weekly numerical rating scale for urgency/frequency (0-10) at 6 weeks, and 3, 6, and 12 months. [ Time Frame: 6 weeks, and 3, 6, and 12 months ] [ Designated as safety issue: No ]
• Cystometric assessment of first sensation and maximal bladder capacity at 6 weeks only. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

• Mean number of daily voiding episodes at 3, 6, and 12 mths
• SF-12 at 6 wks, and 3, 6, and 12 mths
• OAB-q at 6 wks, and 3, 6, and 12 mths
• global assessment of change - urgency/frequency at 6 wks, and 3, 6, and 12 mths
• Average weekly numerical rating scale for urgency/frequency (0-10) at 6 wks, and 3, 6, and 12 mths
• cystometric assessment of first sensation and maximal bladder capacity at 6 weeks only

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.

• Drug: alkalinized xylocaine
  30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
• Drug: placebo
  normal saline
  Other Name: normal saline

• Active Comparator: 1
  xylocaine
  Intervention: Drug: alkalinized xylocaine
• Placebo Comparator: 2
  normal saline
  Intervention: Drug: placebo

• Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12.
• HAINES JS, GRABSTALD H. Xylocaine; a new topical anesthetic in urology. J Urol. 1949 Dec;62(6):901. No abstract available.
• Parsons CL. Successful downregulation of bladder sensory nerves with combination of heparin and alkalinized lidocaine in patients with interstitial cystitis. Urology. 2005 Jan;65(1):45-8.
• Coyne K, Revicki D, Hunt T, Corey R, Stewart W, Bentkover J, Kurth H, Abrams P. Psychometric validation of an overactive bladder symptom and health-related quality of life questionnaire: the OAB-q. Qual Life Res. 2002 Sep;11(6):563-74.

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