Local Anesthetic Treatments for Overactive Bladder

Overactive Bladder Clinical Trial

Official title:

Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00427648
• Other study ID #: EH 06-092
• Status: Terminated
• Phase: Phase 3
• Start date: March 2006
• Est. completion date: May 2010

Study information

• Verified date: February 2020
• Source: NorthShore University HealthSystem
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 22
• Est. completion date: May 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• alkalinized xylocaine
30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
• placebo
normal saline

Locations

Country	Name	City	State
United States	NorthShore University HealthSystem	Evanston	Illinois
United States	NorthShore University HealthSystem	Park City	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Frank Tu	Berlex Foundation

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View Citation

HAINES JS, GRABSTALD H. Xylocaine; a new topical anesthetic in urology. J Urol. 1949 Dec;62(6):901. — View 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. — View Citation

Wein AJ, Rovner ES. Definition and epidemiology of overactive bladder. Urology. 2002 Nov;60(5 Suppl 1):7-12; discussion 12. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.		6 weeks
Secondary	Median Number of Daily Voiding Episodes at 12 Months.		12 months
Secondary	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.	6 weeks
Secondary	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	6 weeks
Secondary	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	6 weeks
Secondary	Average Weekly NRS for Frequency at 6 Weeks	NRS - numerical rating scale, 0-10 is the range, and higher scores are worse frequency	6 weeks
Secondary	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.	6 weeks

External Links

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