Overactive BladderPhase 4NCT00313924
Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome
A Phase 4 study testing DETRUSITOL in people with Overactive Bladder, run by Rambam Health Care Campus at 1 site in Israel.
Trial summary
OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- DETRUSITOL
- How many people
- 100 participants
- Where
- 1 siteIsrael
- Study dates
- Feb 2006to Mar 2006
- Phase
- Phase 4
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- OAB score of ≥ 8
- Age 20-80 years old
- Patients must comply and agree to the requirement of taking only Detrusitol 4mg and no other new medication affecting the lower urinary tract system
Who cannot join
- Patients that are on any other treatment (whether medical or conservative) for OAB.
- Patients with documented UTI.
- Patients who have demonstrated hypersensitivity to the drug or its ingredients.
- Where Detrusitol is contraindicated (i.e. patients with severe outlet obstruction, gastric retention, or uncontrolled narrow-angle glaucoma).
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Rambam Healthcare Center
Haifa, 31096
IRENA GERTMAN, MD
About this study
Official title: The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder.
OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Once treated, evaluation of treatment outcome is problematic since outcome measures for success vary widely (i.e. improvement in number of incontinence episodes, number of urge episodes, change in frequency and nocturia etc) but do not include measures of patient reported outcomes.
The OAB Assessment Tool is a self-administered questionnaire (8-question self-filled survey) primarily intended to identify patients with symptoms of OAB. The same comparable information could be obtained after a certain treatment period, thus providing accurate and precise measures of success. It could also offer insight to the changes of the different parameters that make up the problem. Due to its ease of administration and its high specificity in assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.
Read the detailed description
This study will be a non-randomised, non-placebo controlled prospective clinical trial.
We intend to recruit approximately 100 patients that will receive and fill out the questionnaire before and after medical treatment with detrusitol 4mg.
Study protocol will receive approval of the local ethical committee.
Method:
Twenty general practitioners (GP) will actively participate in the recruitment and treatment of these patients. After a brief inquiry, patients with urinary complaints will be offered the option of completing the OAB-V8 questionnaire and to participate in this trial if eligible.
After the patient fills out the OAB-V8 and is found fit for this study, the patient will receive accurate information regarding the study and will sign an informed consent form.
Protocol:
The study will consist of 2 visits, visit 1 pre and visit 2 post-treatment with Detrusitol 4mg.
Visit I:
Randomly selected patients will be requested to complete the OAB -V8 questionnaire. Those with a score >8 points will be eligible for inclusion. They will complete an informed consent form and will undergo a basic medical history. Patients will then be given treatment with detrusitol 4mg once daily (a total of 28 tablets). They will also be required to fill out a voiding/frequency and urgency chart for three days prior to commencing treatment and again three days before finishing the treatment period (day 25 of the treatment period) to confirm diagnosis of OAB. Patients will also be asked questions and lab work will be performed to rule out patients with other Urinary Conditions.
Information on side effects and a contact number 24/7 for any question or problem that arises will be provided. After the end of one-month treatment, patients will return for their 2nd and final visit.
Twenty-eight tablets of Detrusitol 4mg will be provided to every patient. Visit II: Patients will be evaluated with regard to effect of treatment by completing the OAB-V8 questionnaire again. On this visit, according to the physicians' professional consideration, satisfied patients will receive a prescription of Detrusitol 4mg for continuing treatment.
The statistical methods that will be employed will include Chi Square and Fisher exact tests, and logistic regression (the logistic will be run mainly for covariates such as age, gender and baseline symptom severity score to predict who achieve a 10 point change in symptom bother scale. Software utilised will include SAS and JMP.
- Conditions
- Overactive Bladder
- Being tested
- DETRUSITOL
- Keywords
- URGENCY FREQUENCY SYNDROME, URGE INCONTINENCE
- Medical subject headings
- Urinary Bladder, Overactive, Urinary Incontinence, Urge
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DETRUSITOLDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2006 (estimated)
- Study startFeb 2006
- Study completionMar 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Rambam Health Care Campus
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Investigators
- Ilan Gruenwald, MD, Principal investigator, Rambam Health Care Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313924
- Sponsor's protocol ID
- oab.CTIL
- Status last verified
- Feb 2007
- First submitted
- 10 Apr 2006
- Last updated
- 21 Feb 2007
- Results posted
- No
Publications
Corcos J, Schick E. Prevalence of overactive bladder and incontinence in Canada. Can J Urol. 2004 Jun;11(3):2278-84.
PubMed 15287994Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
PubMed 12811491Milsom I, Stewart W, Thuroff J. The prevalence of overactive bladder. Am J Manag Care. 2000 Jul;6(11 Suppl):S565-73.
PubMed 11183899
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder.
- ClinicalTrials.gov ID
- NCT00313924
- Acronym / sponsor ID
- oab.CTIL
- Conditions
- Overactive Bladder
- Keywords
- URGENCY FREQUENCY SYNDROME, URGE INCONTINENCE
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants
- Lead sponsor
- Rambam Health Care CampusUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Feb 2006
- Study completion
- Mar 2006
- First posted
- 12 Apr 2006 (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.
OAB is a widespread medical problem affecting 6- 30% of the population (both sexes and all age groups) in Europe1 and 16%2-18%3 of the US and Canadian population. Nevertheless only a small proportion of this group turns to seek medical help. Once treated, evaluation of treatment outcome is problematic since outcome measures for success vary widely (i.e. improvement in number of incontinence episodes, number of urge episodes, change in frequency and nocturia etc) but do not include measures of patient reported outcomes.
The OAB Assessment Tool is a self-administered questionnaire (8-question self-filled survey) primarily intended to identify patients with symptoms of OAB. The same comparable information could be obtained after a certain treatment period, thus providing accurate and precise measures of success. It could also offer insight to the changes of the different parameters that make up the problem. Due to its ease of administration and its high specificity in assessing OAB, the OAB Assessment Tool seems to be optimal for this objective.
Detailed description
This study will be a non-randomised, non-placebo controlled prospective clinical trial.
We intend to recruit approximately 100 patients that will receive and fill out the questionnaire before and after medical treatment with detrusitol 4mg.
Study protocol will receive approval of the local ethical committee.
Method:
Twenty general practitioners (GP) will actively participate in the recruitment and treatment of these patients. After a brief inquiry, patients with urinary complaints will be offered the option of completing the OAB-V8 questionnaire and to participate in this trial if eligible.
After the patient fills out the OAB-V8 and is found fit for this study, the patient will receive accurate information regarding the study and will sign an informed consent form.
Protocol:
The study will consist of 2 visits, visit 1 pre and visit 2 post-treatment with Detrusitol 4mg.
Visit I:
Randomly selected patients will be requested to complete the OAB -V8 questionnaire. Those with a score >8 points will be eligible for inclusion. They will complete an informed consent form and will undergo a basic medical history. Patients will then be given treatment with detrusitol 4mg once daily (a total of 28 tablets). They will also be required to fill out a voiding/frequency and urgency chart for three days prior to commencing treatment and again three days before finishing the treatment period (day 25 of the treatment period) to confirm diagnosis of OAB. Patients will also be asked questions and lab work will be performed to rule out patients with other Urinary Conditions.
Information on side effects and a contact number 24/7 for any question or problem that arises will be provided. After the end of one-month treatment, patients will return for their 2nd and final visit.
Twenty-eight tablets of Detrusitol 4mg will be provided to every patient. Visit II: Patients will be evaluated with regard to effect of treatment by completing the OAB-V8 questionnaire again. On this visit, according to the physicians' professional consideration, satisfied patients will receive a prescription of Detrusitol 4mg for continuing treatment.
The statistical methods that will be employed will include Chi Square and Fisher exact tests, and logistic regression (the logistic will be run mainly for covariates such as age, gender and baseline symptom severity score to predict who achieve a 10 point change in symptom bother scale. Software utilised will include SAS and JMP.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- OAB score of ≥ 8
- Age 20-80 years old
- Patients must comply and agree to the requirement of taking only Detrusitol 4mg and no other new medication affecting the lower urinary tract system
Key exclusion criteria (4 listed)
- Patients that are on any other treatment (whether medical or conservative) for OAB.
- Patients with documented UTI.
- Patients who have demonstrated hypersensitivity to the drug or its ingredients.
- Where Detrusitol is contraindicated (i.e. patients with severe outlet obstruction, gastric retention, or uncontrolled narrow-angle glaucoma).
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 |
|---|---|---|
| DETRUSITOL | Drug | – |
Primary outcome
A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2007.
- Background: PubMed 15287994Corcos J, Schick E. Prevalence of overactive bladder and incontinence in Canada. Can J Urol. 2004 Jun;11(3):2278-84.
- Background: PubMed 12811491Stewart WF, Van Rooyen JB, Cundiff GW, Abrams P, Herzog AR, Corey R, Hunt TL, Wein AJ. Prevalence and burden of overactive bladder in the United States. World J Urol. 2003 May;20(6):327-36. doi: 10.1007/s00345-002-0301-4. Epub 2002 Nov 15.
- Background: PubMed 11183899Milsom I, Stewart W, Thuroff J. The prevalence of overactive bladder. Am J Manag Care. 2000 Jul;6(11 Suppl):S565-73.
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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.
Ilan Gruenwald, MD principal investigator
Rambam Health Care Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing DETRUSITOL in people with Overactive Bladder, run by Rambam Health Care Campus at 1 site in Israel.
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 4 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: status not confirmed, as of the sponsor's last update on 21 Feb 2007. 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 Israel. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ilan Gruenwald, MD (00972-4-8542882, I_gruenwald@rambam.health.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.. 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 NCT00313924, which also lists 3 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 21 Feb 2007.