Local Anesthetic Treatments for Overactive Bladder

NCT00427648 | Terminated Phase 3 Results

• 1 other identifier: EH 06-092
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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).

Conditions

Overactive Bladder

Keywords

Administration, Intravesical; Anesthetics, Local

Outcome Measures

Primary Outcomes (1)

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

  6 weeks

Secondary Outcomes (6)

• Median Number of Daily Voiding Episodes at 12 Months.

  12 months

• SF-12 Physical at 6 Weeks

  6 weeks

• OAB-q (Symptom Scale) at 6 Weeks

  6 weeks

• Global Assessment of Change - Frequency at 6 Weeks

  6 weeks

• Average Weekly NRS for Frequency at 6 Weeks

  6 weeks

Study Arms (2)

1

ACTIVE COMPARATOR

xylocaine

Drug: alkalinized xylocaine

2

PLACEBO COMPARATOR

normal saline

Drug: placebo

Interventions

alkalinized xylocaine DRUG

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

1

placebo DRUG

normal saline

Also known as: normal saline

2

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Frank Tu: lead
• Berlex Foundation: collaborator

Study Sites (2)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

NorthShore University HealthSystem

Park City, Illinois, 60085, United States

Location

Related Publications (4)

• 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.

  PMID: 12493342 BACKGROUND

• 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.

  PMID: 15394388 BACKGROUND

• 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.

  PMID: 15667861 BACKGROUND

• 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.

  PMID: 12206577 BACKGROUND

Related Links

• 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

MeSH Terms

Conditions

Urinary Bladder, Overactive

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

Limitations include the large amount of women unwilling to participate, the repeated need for catheterization for six instillations and two cystometries, the loss of subjects to follow-up, and some missing diaries of recorded daily voids.

Results Point of Contact

• Title: Frank F. Tu
• Organization: NorthShore Health

ftu@northshore.org

8475702521

Study Officials

• Frank F. Tu, MD, MPH

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Division Director, Gynecological Pain and Minimally Invasive Surgery, Department of Obstetrics and Gynecology

Study Record Dates

• First Submitted: January 26, 2007
• First Posted: January 29, 2007
• Study Start: March 1, 2006
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: March 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-02

Locations

US (2)