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Local Anesthetic Treatments for Overactive Bladder

This study has been terminated.
(Data collection complete; analysis to take place)
Sponsor:
Collaborator:
Berlex Foundation
Information provided by (Responsible Party):
Frank F. Tu, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier:
NCT00427648
First received: January 26, 2007
Last updated: March 14, 2014
Last verified: March 2014

January 26, 2007
March 14, 2014
March 2006
May 2010   (final data collection date for primary outcome measure)
Mean number of daily voiding episodes (by 3-day voiding diary) at six weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Mean number of daily voiding episodes (by 3 day voiding diary) at six wks.
Complete list of historical versions of study NCT00427648 on ClinicalTrials.gov Archive Site
  • 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
Not Provided
Not Provided
 
Local Anesthetic Treatments for Overactive Bladder
Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Overactive Bladder
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
22
May 2010
May 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00427648
EH 06-092
No
Frank F. Tu, NorthShore University HealthSystem Research Institute
Frank F. Tu
Berlex Foundation
Principal Investigator: Frank F. Tu, MD, MPH NorthShore University HealthSystem
NorthShore University HealthSystem Research Institute
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP