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Local Anesthetic Treatments for Overactive Bladder

Primary Purpose

Overactive Bladder

Status

Terminated

Phase

Phase 3

Locations

United States

Study Type

Interventional

Intervention

alkalinized xylocaine

placebo

About this trial

This is an interventional treatment trial for Overactive Bladder focused on measuring Administration, Intravesical, Anesthetics, Local

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

NorthShore University HealthSystem
NorthShore University HealthSystem

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

xylocaine

normal saline

Outcomes

Primary Outcome Measures

Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.

Secondary Outcome Measures

Median Number of Daily Voiding Episodes at 12 Months.

SF-12 Physical at 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.

OAB-q (Symptom Scale) at 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

Global Assessment of Change - Frequency at 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

Average Weekly NRS for Frequency at 6 Weeks

NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency

Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.

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.

Full Information

NCT ID

NCT00427648

First Posted

January 26, 2007

Last Updated

February 22, 2020

Sponsor

Frank Tu

Collaborators

Berlex Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00427648

Brief Title

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

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Terminated

Why Stopped

funding ran out, poor accrual.

Study Start Date

March 2006 (undefined)

Primary Completion Date

May 2010 (Actual)

Study Completion Date

May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Frank Tu

Collaborators

Berlex Foundation

4. Oversight

Data Monitoring Committee

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Overactive Bladder

Keywords

Administration, Intravesical, Anesthetics, Local

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

22 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

xylocaine

Arm Title

Arm Type

Placebo Comparator

Arm Description

normal saline

Intervention Type

Drug

Intervention Name(s)

alkalinized xylocaine

Intervention Description

30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks

Intervention Type

Drug

Intervention Name(s)

placebo

Other Intervention Name(s)

normal saline

Intervention Description

normal saline

Primary Outcome Measure Information:

Title

Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.

Time Frame

6 weeks

Secondary Outcome Measure Information:

Title

Median Number of Daily Voiding Episodes at 12 Months.

Time Frame

12 months

Title

SF-12 Physical at 6 Weeks

Description

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.

Time Frame

6 weeks

Title

OAB-q (Symptom Scale) at 6 Weeks

Description

OAB-q SS is a 7 item overactive bladder symptom bother sub scale, ranging from 0-100, higher scores mean worse outcome for bother

Time Frame

6 weeks

Title

Global Assessment of Change - Frequency at 6 Weeks

Description

This is patient overall assessment of change in overactive bladder symptoms after treatment. 0% is no change, 100% is total resolution of symptoms

Time Frame

6 weeks

Title

Average Weekly NRS for Frequency at 6 Weeks

Description

NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency

Time Frame

6 weeks

Title

Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.

Description

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.

Time Frame

6 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

100 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Frank F. Tu, MD, MPH

Organizational Affiliation

NorthShore University HealthSystem

Official's Role

Principal Investigator

Facility Information:

Facility Name

NorthShore University HealthSystem

City

Evanston

State/Province

Illinois

ZIP/Postal Code

60201

Country

United States

Facility Name

NorthShore University HealthSystem

City

Park City

State/Province

Illinois

ZIP/Postal Code

60085

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

12493342

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.

Results Reference

background

PubMed Identifier

15394388

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.

Results Reference

background

PubMed Identifier

15667861

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.

Results Reference

background

PubMed Identifier

12206577

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.

Results Reference

background

Links:

URL

http://www.northshore.org/clinicalservices/womenshealth/research/default.aspx?id=4429

Description

Click here for more information about this study: Intravesical alkalized lidocaine for the treatment of overactive bladder (OAB), a randomized, prospective double-blinded controlled trial

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Local Anesthetic Treatments for Overactive Bladder

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