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funding ran out, poor accrual.
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| Name | Class |
|---|---|
| Berlex Foundation | OTHER |
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The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator | xylocaine |
|
| 2 | Placebo Comparator | normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| alkalinized xylocaine | Drug | 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Median Number of Daily Voiding Episodes at 12 Months. | 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. |
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Inclusion criteria:
Female patient, 18 years of age and older
Overactive bladder defined as:
Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank F. Tu, MD, MPH | Endeavor Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NorthShore University HealthSystem | Evanston | Illinois | 60201 | United States | ||
| NorthShore University HealthSystem |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12493342 | Background | 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. | |
| 15394388 | 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. |
| Label | URL |
|---|---|
| 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 | View source |
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no wash out, no run-in
Two medical clinic sites were used between January 2007 and March 2011, initially the Evanston Continence Center (Evanston, IL), and subsequently to augment recruitment, North Shore Urogynecology (Lake Forest, IL, added July 2009).
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| ID | Title | Description |
|---|---|---|
| FG000 | 1/Active | alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate |
| FG001 | 2/Placebo | normal saline |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 1/Active | alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate |
| BG001 | 2/Placebo | normal saline |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | did not analyze patients eliminated from study due to protocol deviation and withdrawal due to AE |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks. | only 16 participants completed this diary | Posted | Median | Inter-Quartile Range | voids/day | 6 weeks |
|
|
12 months
Adverse event inventories were completed at each of 6 biweekly instillation visits and also at week 6, and 3,6, and 12 month followup visits
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 1/Active | alkalinized xylocaine: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bladder infection | Renal and urinary disorders | Systematic Assessment |
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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Frank F. Tu | NorthShore Health | 8475702521 | ftu@northshore.org |
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| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| placebo | Drug | normal saline |
|
|
| 6 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| Park City |
| Illinois |
| 60085 |
| United States |
| 15667861 | 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. |
| 12206577 | 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. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | 3 withdrawal of consents, and 1 patient with AE excluded from analysis | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| length of OAB symptoms | protocol withdrawals = 3 and 1 with AE not included | Mean | Standard Deviation | years |
|
| prior anticholinergic use | 3 withdrawals and 1 AE not included | Count of Participants | Participants |
|
|
|
|
| Secondary | Median Number of Daily Voiding Episodes at 12 Months. | Posted | Median | Inter-Quartile Range | voids/day | 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. | Posted | Median | Inter-Quartile Range | score on scale | 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 | Posted | Median | Inter-Quartile Range | score on a scale | 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 | Posted | Median | Inter-Quartile Range | percent improvement | 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 | Not all women completed this measure | Posted | Median | Inter-Quartile Range | score on a 0-10 scale | 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. | Not all women were able to return for cystometry | Posted | Median | Inter-Quartile Range | mL | 6 weeks |
|
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| 3 |
| 11 |
| EG001 | 2/Placebo | normal saline | 0 | 7 | 0 | 7 | 2 | 7 |
| pain in lower abdomen | General disorders | Systematic Assessment | week 3 only |
|
| nausea | Gastrointestinal disorders | Systematic Assessment | week 3 only |
|
| pelvic pain | Reproductive system and breast disorders | Systematic Assessment |
|
| dysuria | Renal and urinary disorders | Systematic Assessment |
|
| urinary hesitancy | Renal and urinary disorders | Systematic Assessment |
|
| light headedness | Nervous system disorders | Systematic Assessment |
|
| headache | Nervous system disorders | Systematic Assessment |
|
| sleepiness | General disorders | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|