Overactive BladderPhase 3NCT00427648
Local Anesthetic Treatments for Overactive Bladder
A Phase 3 study testing alkalinized xylocaine in people with Overactive Bladder, run by Frank Tu at 2 sites in United States.
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). Read more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- alkalinized xylocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- Mar 2006to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
NorthShore University HealthSystem
Evanston, Illinois, 60201
NorthShore University HealthSystem
Park City, Illinois, 60085
About this study
Official title: 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).
Read the 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.
- Conditions
- Overactive Bladder
- Being tested
- alkalinized xylocaine, placebo
- Keywords
- Administration, Intravesical, Anesthetics, Local
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alkalinized xylocaineDrug
30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks
placeboDrug
Also called normal saline
normal saline
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | xylocaine Receives: Drug: alkalinized xylocaine |
| 2 | Placebo comparator | normal saline Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
Measured: 6 weeks
Secondary outcomes (6)
Median Number of Daily Voiding Episodes at 12 Months.
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2007 (estimated)
- Study startMar 2006
- Primary completionMay 2010
- Study completionMay 2010
Why it stopped: funding ran out, poor accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frank Tu
- Sponsor type
- University, hospital or other
- Collaborators
- Berlex Foundation
- Responsible party
- Sponsor-investigator, Frank Tu, Endeavor Health
- Investigators
- Frank F. Tu, MD, MPH, Principal investigator, Endeavor Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00427648
- Sponsor's protocol ID
- EH 06-092
- Status last verified
- Feb 2020
- First submitted
- 26 Jan 2007
- Last updated
- 6 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 12493342HAINES 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.
PubMed 15394388Parsons 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.
PubMed 15667861Coyne 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.
PubMed 12206577
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravesical Alkalized Lidocaine for the Treatment of Overactive Bladder (OAB), a Randomized, Double-blinded Controlled Trial
- ClinicalTrials.gov ID
- NCT00427648
- Acronym / sponsor ID
- EH 06-092
- Conditions
- Overactive Bladder
- Keywords
- Administration, Intravesical, Anesthetics, Local
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: funding ran out, poor accrual.
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Frank TuUniversity, hospital or other
- Collaborators
- Berlex Foundation
- Study start
- Mar 2006
- Primary completion
- May 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 29 Jan 2007 (estimated)
- Results
- Posted 6 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: alkalinized xylocainexylocaine |
| 2 | Placebo comparator | Drug: placebonormal saline |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patient, 18 years of age and older
- Overactive bladder defined as:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| alkalinized xylocaine30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks | Drug | 1 |
| placeboAlso: normal salinenormal saline | Drug | 2 |
Primary outcome
Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks.
Time frame: 6 weeks
6 secondary outcomes
Median Number of Daily Voiding Episodes at 12 Months.
Time frame: 12 months
SF-12 Physical at 6 Weeks
Time frame: 6 weeks
OAB-q (Symptom Scale) at 6 Weeks
Time frame: 6 weeks
Global Assessment of Change - Frequency at 6 Weeks
Time frame: 6 weeks
Average Weekly NRS for Frequency at 6 Weeks
Time frame: 6 weeks
Cystometric Assessment of Maximal Bladder Capacity at 6 Weeks Only.
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 12493342Wein 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.
- Background: PubMed 15394388HAINES 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.
- Background: PubMed 15667861Parsons 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.
- Background: PubMed 12206577Coyne 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.
- Click here for more information about this study: Intravesical alkalized lidocaine for the treatment of overactive bladder (OAB), a randomized, prospective double-blinded controlled trialLink provided by the sponsor.
Related trials for Overactive Bladder
Not yet recruitingPhase 4
Behavioral and/or Mirabegron to Treat Urinary Symptoms in Parkinson Disease
Overactive Bladder, Parkinson Disease
Recruiting
Ambulatory Long Length URodynamics Evaluation
Urology, Urinary Bladder, Overactive
Active, not recruiting
APPROVE Trial: Evaluating a Prescription Digital Therapeutic for Treatment of OAB in Women
Overactive Bladder (OAB), Urinary Urgency
Not yet recruiting
Transcranial Direct Current Stimulation for Neurogenic Overactive Bladder Symptoms Among People With Stroke
Stroke, Neurogenic Overactive Bladder
RecruitingObservational study
Tensi+ European Post-Market Clinical Follow-Up
Overactive Bladder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Frank F. Tu, MD, MPH principal investigator
Endeavor Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alkalinized xylocaine in people with Overactive Bladder, run by Frank Tu at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median Number of Daily Voiding Episodes (by 3-day Voiding Diary) at Six Weeks. (time frame: 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00427648, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2020.