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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2007 by Rambam Health Care Campus.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Pfizer
Information provided by:
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT00313924
First received: April 10, 2006
Last updated: February 19, 2007
Last verified: February 2007
  Purpose

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 Intervention Phase
Overactive Bladder
Drug: DETRUSITOL
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Applicability of the OAB Assessment Tool for Evaluation of Treatment Efficacy of Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

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

Estimated Enrollment: 100
Study Start Date: February 2006
Estimated Study Completion Date: March 2006
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.

  Eligibility

Ages Eligible for Study:   20 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313924

Contacts
Contact: Ilan Gruenwald, MD 00972-4-8542882 I_gruenwald@rambam.health.gov.il
Contact: Yoram Vardi, Prof 00972-4-8542819 yvardi@rambam.health.gov.il

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

Publications:
ClinicalTrials.gov Identifier: NCT00313924     History of Changes
Other Study ID Numbers: oab.CTIL
Study First Received: April 10, 2006
Last Updated: February 19, 2007
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Rambam Health Care Campus:
URGENCY FREQUENCY SYNDROME
URGE INCONTINENCE

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Lower Urinary Tract Symptoms
Signs and Symptoms
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations

ClinicalTrials.gov processed this record on October 23, 2014