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Local Anesthetic Treatments for Overactive Bladder

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ClinicalTrials.gov Identifier: NCT00427648
Recruitment Status : Terminated (Data collection complete; analysis to take place)
First Posted : January 29, 2007
Last Update Posted : March 17, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: alkalinized xylocaine Drug: placebo Phase 3

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial
Study Start Date : March 2006
Primary Completion Date : May 2010
Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
xylocaine
Drug: alkalinized xylocaine
30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
Placebo Comparator: 2
normal saline
Drug: placebo
normal saline
Other Name: normal saline


Outcome Measures

Primary Outcome Measures :
  1. Mean number of daily voiding episodes (by 3-day voiding diary) at six weeks. [ Time Frame: 6 weeks ]

Secondary Outcome Measures :
  1. Mean number of daily voiding episodes at 3, 6, and 12 months. [ Time Frame: 3, 6, 12 months ]
  2. SF-12 at 6 weeks, and 3, 6, and 12 months. [ Time Frame: 6 weeks and 3, 6, and 12 months ]
  3. OAB-q at 6 weeks, and 3, 6, and 12 months. [ Time Frame: 6 weeks and 3, 6, and 12 months ]
  4. 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 ]
  5. 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 ]
  6. Cystometric assessment of first sensation and maximal bladder capacity at 6 weeks only. [ Time Frame: 6 weeks ]

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00427648


Locations
United States, Illinois
NorthShore University HealthSystem
Evanston, Illinois, United States, 60201
NorthShore University HealthSystem
Park City, Illinois, United States, 60085
Sponsors and Collaborators
Frank F. Tu
Berlex Foundation
Investigators
Principal Investigator: Frank F. Tu, MD, MPH NorthShore University HealthSystem
More Information

Additional Information:
Publications:
Responsible Party: Frank F. Tu, Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology, NorthShore University HealthSystem Research Institute
ClinicalTrials.gov Identifier: NCT00427648     History of Changes
Other Study ID Numbers: EH 06-092
First Posted: January 29, 2007    Key Record Dates
Last Update Posted: March 17, 2014
Last Verified: March 2014

Keywords provided by Frank F. Tu, NorthShore University HealthSystem Research Institute:
Administration, Intravesical
Anesthetics, Local

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Anesthetics
Lidocaine
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Local
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action