Overactive BladderNCT00780832
Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
A study testing Dietary Caffeine reduction and Anticholinergic medication in people with Overactive Bladder, run by IWK Health Centre at 1 site in Canada.
Trial summary
The purpose of this study is to assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Dietary Caffeine reduction and Anticholinergic medication
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteCanada
- Study dates
- May 2008to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence
- Women who consume > one cup (250ml) caffeinated beverage per day
- Women who score $ 6 on the QUID Questionnaire for urgency symptoms
Who cannot join
- Women currently receiving treatment for OAB symptoms
- Women with narrow angle Glaucoma
- Women taking anticholinergics or loop diuretics
- Women with an untreated urinary tract infection. After resolution of the UTI, and if all other eligibility criteria are met, the woman can be a candidate for inclusion in the study.
- Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions
- Women scoring >4 on the QUID Questionnaire for stress symptoms
- Women with de novo symptoms following surgery
- Women with major pelvic prolapse
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and determine how effective caffeine reduction is compared to medication. If caffeine reduction is shown to be beneficial, women may be encouraged to use this strategy before resorting to medications.
Read the detailed description
Urinary symptoms such as frequency, urgency, nocturia, and incontinence occur in many women. Overactive bladder (OAB) accounts for forty to seventy percent of urinary incontinence. These symptoms can be mildly annoying to life altering. Many women wear pads or adult diapers daily and avoid social situations for fear of embarrassment. It is felt that up to sixteen percent of the adult population may suffer from these symptoms and many of these women seek medical help.
Currently, the standard of care for OAB includes some combination of lifestyle modification counseling, bladder retraining, or anticholinergic medications. It is anticipated that stimulants such as caffeine irritate the bladder and exacerbate OAB symptoms. There have been a few studies looking at the effect of caffeine but interventions have varied, and the results have been mixed.
Perhaps the most common treatment for significant OAB symptoms is the prescription of anticholinergic medications. We know that these are efficacious in many women but they can be expensive and have significant side effects4. In fact, many women discontinue their anticholinergics due to dry mouth, dry eyes, gastrointestinal, and genitourinary effects.
To date there have been no studies comparing caffeine reduction to anticholinergic medications.
Research Questions
- Does caffeine reduction decrease OAB symptoms?
- Does the amount of caffeine consumed relate to symptom severity?
- If symptoms do improve with caffeine reduction, are women compliant with this treatment?
- How does caffeine reduction compare to anticholinergic medication in treating OAB?
Study Goal:Compare caffeine reduction to anticholinergic medication as a treatment for overactive bladder.
Study Design:Randomized prospective study. Eligible participants will be randomized to either the anticholinergic arm or the caffeine reduction arm.
- Conditions
- Overactive Bladder
- Being tested
- Dietary Caffeine reduction, Anticholinergic medication
- Keywords
- overactive bladder, dietary caffeine, anticholinergic medication, lifestyle modification, incontinence, urinary frequency
- 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.
Dietary Caffeine reductionBehavioural
Also called Lifestyle modification
Participants are counseled about reduction of dietary caffeine, given written information and a bladder control log.
Anticholinergic medicationDrug
Detrol LA 4mg. orally, once daily for 30 days
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Caffeine reduction through diet and beverage counselling Receives: Behavioral: Dietary Caffeine reduction |
| 2 | Active comparator | Anticholinergic medication Receives: Drug: Anticholinergic medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bladder Function Questionnaire score
Measured: 30 days
Secondary outcomes (1)
Does the amount of caffeine consumed relate to symptom severity?
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2008 (estimated)
- Study startMay 2008
- Primary completionDec 2012
- Study completionApr 2013
Why it stopped: Insufficient elligible patients available in a reasonable time frame.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Scott A Farrell, MD, FRCSC, Principal investigator, IWK Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00780832
- Sponsor's protocol ID
- REB #4121
- Status last verified
- May 2013
- First submitted
- 27 Oct 2008
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Caffeine Reduction and Anticholinergic Medications for Treatment of Overactive Bladder
- ClinicalTrials.gov ID
- NCT00780832
- Acronym / sponsor ID
- REB #4121
- Conditions
- Overactive Bladder
- Keywords
- overactive bladder, dietary caffeine, anticholinergic medication, lifestyle modification, incontinence, urinary frequency
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient elligible patients available in a reasonable time frame.
- Enrolment
- 8 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Dec 2012 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 28 Oct 2008 (estimated)
- Results
- Not posted in the source record
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 assess the effects of caffeine reduction/elimination on urinary symptoms in women with overactive bladders and compare this therapeutic approach to anticholinergic therapy. We hope to show a reduction in symptoms with caffeine reduction and determine how effective caffeine reduction is compared to medication. If caffeine reduction is shown to be beneficial, women may be encouraged to use this strategy before resorting to medications.
Detailed description
Urinary symptoms such as frequency, urgency, nocturia, and incontinence occur in many women. Overactive bladder (OAB) accounts for forty to seventy percent of urinary incontinence. These symptoms can be mildly annoying to life altering. Many women wear pads or adult diapers daily and avoid social situations for fear of embarrassment. It is felt that up to sixteen percent of the adult population may suffer from these symptoms and many of these women seek medical help.
Currently, the standard of care for OAB includes some combination of lifestyle modification counseling, bladder retraining, or anticholinergic medications. It is anticipated that stimulants such as caffeine irritate the bladder and exacerbate OAB symptoms. There have been a few studies looking at the effect of caffeine but interventions have varied, and the results have been mixed.
Perhaps the most common treatment for significant OAB symptoms is the prescription of anticholinergic medications. We know that these are efficacious in many women but they can be expensive and have significant side effects4. In fact, many women discontinue their anticholinergics due to dry mouth, dry eyes, gastrointestinal, and genitourinary effects.
To date there have been no studies comparing caffeine reduction to anticholinergic medications.
Research Questions
- Does caffeine reduction decrease OAB symptoms?
- Does the amount of caffeine consumed relate to symptom severity?
- If symptoms do improve with caffeine reduction, are women compliant with this treatment?
- How does caffeine reduction compare to anticholinergic medication in treating OAB?
Study Goal:Compare caffeine reduction to anticholinergic medication as a treatment for overactive bladder.
Study Design:Randomized prospective study. Eligible participants will be randomized to either the anticholinergic arm or the caffeine reduction arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Dietary Caffeine reductionCaffeine reduction through diet and beverage counselling |
| 2 | Active comparator | Drug: Anticholinergic medicationAnticholinergic medication |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Women with OAB symptoms including urgency, frequency (voids ≥8/day), and urge incontinence
- Women who consume > one cup (250ml) caffeinated beverage per day
- Women who score $ 6 on the QUID Questionnaire for urgency symptoms
Key exclusion criteria (8 listed)
- Women currently receiving treatment for OAB symptoms
- Women with narrow angle Glaucoma
- Women taking anticholinergics or loop diuretics
- Women with an untreated urinary tract infection. After resolution of the UTI, and if all other eligibility criteria are met, the woman can be a candidate for inclusion in the study.
- Women with a diagnosis of painful bladder syndrome or other abnormal urinary tract lesions
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 |
|---|---|---|
| Dietary Caffeine reductionAlso: Lifestyle modificationParticipants are counseled about reduction of dietary caffeine, given written information and a bladder control log. | Behavioural | 1 |
| Anticholinergic medicationDetrol LA 4mg. orally, once daily for 30 days | Drug | 2 |
Primary outcome
Change in Bladder Function Questionnaire score
Time frame: 30 days
1 secondary outcome
Does the amount of caffeine consumed relate to symptom severity?
Time frame: 30 days
Results and safety
The study was stopped early (reason given: Insufficient elligible patients available in a reasonable time frame.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
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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.
Scott A Farrell, MD, FRCSC principal investigator
IWK Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dietary Caffeine reduction and Anticholinergic medication in people with Overactive Bladder, run by IWK Health Centre at 1 site in Canada.
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 3 inclusion and 8 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 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Insufficient elligible patients available in a reasonable time frame.). Results are not available in the source record.
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?
Change in Bladder Function Questionnaire score (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Feb 2016.