Clinical trial NCT00427648: Local Anesthetic Treatments for Overactive Bladder
Official title: Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Overactive Bladder
Keywords: Administration, Intravesical
Anesthetics, Local
Lead sponsor: Endeavor Health
Sponsor class: OTHER
Collaborators: name: Berlex Foundation
First posted: 2007-01-29
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
timeFrame: 6 weeks
Secondary outcomes:
measure: Median Number of Daily Voiding Episodes at 12 Months.
timeFrame: 12 months
measure: SF-12 Physical at 6 Weeks
timeFrame: 6 weeks
measure: OAB-q (Symptom Scale) at 6 Weeks
timeFrame: 6 weeks
measure: Global Assessment of Change - Frequency at 6 Weeks
timeFrame: 6 weeks
measure: Average Weekly NRS for Frequency at 6 Weeks
timeFrame: 6 weeks
measure: Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Evanston
country: United States
facility: NorthShore University HealthSystem
state: Illinois
city: Park City
country: United States
facility: NorthShore University HealthSystem
state: Illinois
Study officials:
affiliation: Endeavor Health
name: Frank F. Tu, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. doi: 10.1016/s0090-4295(02)01784-3.
citation: HAINES JS, GRABSTALD H. Xylocaine; a new topical anesthetic in urology. J Urol. 1949 Dec;62(6):901. doi: 10.1016/S0022-5347(17)69020-7. No abstract available.
citation: 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. doi: 10.1016/j.urology.2004.08.056.
citation: 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. doi: 10.1023/a:1016370925601.