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A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder

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.
 
ClinicalTrials.gov Identifier: NCT00137397
Recruitment Status : Completed
First Posted : August 29, 2005
Last Update Posted : October 6, 2006
Sponsor:
Information provided by:
Pfizer

Study Description
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Brief Summary:
The main aim of the study is to investigate whether taking Tolterodine for overactive bladder symptoms can reduce the thickness of the bladder wall, as measured by intra-vaginal ultrasound. This will help doctors to understand whether there is a link between changes in the thickness of the bladder wall and progression of symptoms.

Condition or disease Intervention/treatment Phase
Urinary Incontinence Drug: Tolterodine ER Drug: Placebo Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Multi-Centre, Randomised, Placebo Controlled, Double Blind, Parallel Group Study in Female Patients to Evaluate Whether Tolterodine ER Can Reverse the Increased Bladder Wall Thickness in Patients With Overactive Bladder.
Study Start Date : November 2004
Study Completion Date : August 2006

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Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.

Secondary Outcome Measures :
  1. Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptoms of overactive bladder (described as urinary urgency, with or without urge incontinence, usually with frequency and nocturia for more than 6 months
  • Bladder wall thickness of 5mm or more

Exclusion Criteria:

  • Treatment in the previous four weeks with an anticholinergic drug or any drug for the treatment of overactive bladder.
  • Significant stress incontinence - Urinary tract infection or a history of intermittent urinary tract infections (more than four episodes in the last two years).
  • Conditions considered significant by the investigator (e.g. cystocoele, significant bladder prolapse, bladder stone, indwelling catheter etc)
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT00137397


Locations
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United Kingdom
Pfizer Investigational Site
Blackburn, Lancashire, United Kingdom, BB2 3HH
Pfizer Investigational Site
Harrow, Middx, United Kingdom, HA1 3UJ
Pfizer Investigational Site
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Pfizer Investigational Site
Livingston, West Lothian, United Kingdom, EH54 6PP
Pfizer Investigational Site
Basingstoke, United Kingdom, RG24 9NA
Pfizer Investigational Site
Birmingham, United Kingdom, B15 2TG
Pfizer Investigational Site
Cambs, United Kingdom, PE18 8NT
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
London, United Kingdom, W2 2YP
Pfizer Investigational Site
Northampton, United Kingdom, NN1 5BD
Pfizer Investigational Site
Pl6 8Dh, United Kingdom
Sponsors and Collaborators
Pfizer
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
More Information
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Additional Information:

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ClinicalTrials.gov Identifier: NCT00137397    
Other Study ID Numbers: A6121006
First Posted: August 29, 2005    Key Record Dates
Last Update Posted: October 6, 2006
Last Verified: October 2006
Additional relevant MeSH terms:
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Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Urinary Bladder Diseases
Tolterodine Tartrate
 Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents