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
  Purpose

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 Intervention Phase
Overactive Bladder
Drug: alkalinized xylocaine
Drug: placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial

Resource links provided by NLM:


Further study details as provided by NorthShore University HealthSystem Research Institute:

Primary Outcome Measures:
  • Mean number of daily voiding episodes (by 3-day voiding diary) at six weeks. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 22
Study Start Date: March 2006
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   18 Years and older
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: January 26, 2007
Last Updated: March 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NorthShore University HealthSystem Research Institute:
Administration, Intravesical
Anesthetics, Local

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

ClinicalTrials.gov processed this record on October 22, 2014