Local Anesthetic Treatments for Overactive Bladder

February 22, 2020 updated by: Frank Tu

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
      • Park City, Illinois, United States, 60085
        • Northshore University Healthsystem

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 2
normal saline
Drug: placebo
normal saline
Other Names:
  • normal saline
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
Time Frame: 6 weeks
6 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Median Number of Daily Voiding Episodes at 12 Months.
Time Frame: 12 months
12 months
SF-12 Physical at 6 Weeks
Time Frame: 6 weeks
SF-12 physical is an abbreviated version of the SF-36 a widely used, general health care quality of life instrument. Scores range from 0-100, and higher scores are better outcomes.
6 weeks
OAB-q (Symptom Scale) at 6 Weeks
Time Frame: 6 weeks
OAB-q SS is a 7 item overactive bladder symptom bother sub scale, ranging from 0-100, higher scores mean worse outcome for bother
6 weeks
Global Assessment of Change - Frequency at 6 Weeks
Time Frame: 6 weeks
This is patient overall assessment of change in overactive bladder symptoms after treatment. 0% is no change, 100% is total resolution of symptoms
6 weeks
Average Weekly NRS for Frequency at 6 Weeks
Time Frame: 6 weeks
NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency
6 weeks
Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.
Time Frame: 6 weeks
This is based on retrograde infusion of sterile water into the bladder using a catheter, the maximum tolerated volume serving to define how much distension a woman can tolerate.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Frank Tu

Collaborators

Berlex Foundation

Investigators

  • Principal Investigator: Frank F. Tu, MD, MPH, Northshore University Healthsystem

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

January 26, 2007

First Submitted That Met QC Criteria

January 26, 2007

First Posted (Estimate)

January 29, 2007

Study Record Updates

Last Update Posted (Actual)

March 6, 2020

Last Update Submitted That Met QC Criteria

February 22, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EH 06-092

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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