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Assessing the OAB-8 Questionnaire as a Tool to Measure Treatment Outcome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by:
Rambam Health Care Campus

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Overactive Bladder Drug: DETRUSITOL Phase 4

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.


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.

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder.
Study Start Date : February 2006
Study Completion Date : March 2006

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. A significant correlation between reduced urinary symptoms and a reduction of more than 10 points in the OAB-8 score.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. OAB score of ≥ 8
  2. Age 20-80 years old
  3. Patients must comply and agree to the requirement of taking only Detrusitol 4mg and no other new medication affecting the lower urinary tract system

Exclusion criteria:

  1. Patients that are on any other treatment (whether medical or conservative) for OAB.
  2. Patients with documented UTI.
  3. Patients who have demonstrated hypersensitivity to the drug or its ingredients.
  4. Where Detrusitol is contraindicated (i.e. patients with severe outlet obstruction, gastric retention, or uncontrolled narrow-angle glaucoma).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313924

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Contact: Ilan Gruenwald, MD 00972-4-8542882
Contact: Yoram Vardi, Prof 00972-4-8542819

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Rambam Healthcare Center Recruiting
Haifa, Israel, 31096
Sub-Investigator: IRENA GERTMAN, MD         
Sponsors and Collaborators
Rambam Health Care Campus
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Principal Investigator: Ilan Gruenwald, MD Rambam Health Care Campus

Layout table for additonal information Identifier: NCT00313924     History of Changes
Other Study ID Numbers: oab.CTIL
First Posted: April 12, 2006    Key Record Dates
Last Update Posted: February 21, 2007
Last Verified: February 2007
Keywords provided by Rambam Health Care Campus:
Additional relevant MeSH terms:
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Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Tolterodine Tartrate
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents