Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome
|ClinicalTrials.gov Identifier: NCT00313924|
Recruitment Status : Unknown
Verified February 2007 by Rambam Health Care Campus.
Recruitment status was: Recruiting
First Posted : April 12, 2006
Last Update Posted : February 21, 2007
|First Submitted Date ICMJE||April 10, 2006|
|First Posted Date ICMJE||April 12, 2006|
|Last Update Posted Date||February 21, 2007|
|Study Start Date ICMJE||February 2006|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00313924 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome|
|Official Title ICMJE||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.
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.
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.
The study will consist of 2 visits, visit 1 pre and visit 2 post-treatment with Detrusitol 4mg.
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 Type ICMJE||Interventional|
|Study Phase||Phase 4|
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Overactive Bladder|
|Intervention ICMJE||Drug: DETRUSITOL|
|Study Arms||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Unknown status|
|Original Enrollment ICMJE||Same as current|
|Study Completion Date||March 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||20 Years to 80 Years (Adult, Senior)|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||Israel|
|Removed Location Countries|
|NCT Number ICMJE||NCT00313924|
|Other Study ID Numbers ICMJE||oab.CTIL|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Rambam Health Care Campus|
|PRS Account||Rambam Health Care Campus|
|Verification Date||February 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP