NCT00313924

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Feb 2006

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2006

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 10, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 12, 2006

Completed
Last Updated

February 21, 2007

Status Verified

February 1, 2007

First QC Date

April 10, 2006

Last Update Submit

February 19, 2007

Conditions

Overactive Bladder

Keywords

URGENCY FREQUENCY SYNDROMEURGE INCONTINENCE

Outcome Measures

Primary Outcomes (1)

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

Interventions

DETRUSITOLDRUG

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rambam Healthcare Center

Haifa, 31096, Israel

RECRUITING

Related Publications (3)

  • Corcos J, Schick E. Prevalence of overactive bladder and incontinence in Canada. Can J Urol. 2004 Jun;11(3):2278-84.

    PMID: 15287994BACKGROUND

  • Stewart 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.

    PMID: 12811491BACKGROUND

  • Milsom I, Stewart W, Thuroff J. The prevalence of overactive bladder. Am J Manag Care. 2000 Jul;6(11 Suppl):S565-73.

    PMID: 11183899BACKGROUND

MeSH Terms

Conditions

Urinary Bladder, OveractiveUrinary Incontinence, Urge

Interventions

Tolterodine Tartrate

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsUrinary IncontinenceUrination Disorders

Intervention Hierarchy (Ancestors)

PhenylpropanolaminePropanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsPropanolsAminesBenzhydryl CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsCresolsPhenols

Study Officials

  • Ilan Gruenwald, MD

    Rambam Health Care Campus

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ilan Gruenwald, MD

CONTACT

00972-4-8542882I_gruenwald@rambam.health.gov.il

Yoram Vardi, Prof

CONTACT

00972-4-8542819yvardi@rambam.health.gov.il

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 10, 2006

First Posted

April 12, 2006

Study Start

February 1, 2006

Study Completion

March 1, 2006

Last Updated

February 21, 2007

Record last verified: 2007-02

Locations

IL(1)