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

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137397
First received: August 25, 2005
Last updated: October 5, 2006
Last verified: October 2006
  Purpose

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 Intervention Phase
Urinary Incontinence
Drug: Tolterodine ER
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

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

Estimated Enrollment: 80
Study Start Date: November 2004
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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: NCT00137397

Locations
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
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00137397     History of Changes
Other Study ID Numbers: A6121006
Study First Received: August 25, 2005
Last Updated: October 5, 2006
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Urinary Incontinence
Urinary Bladder, Overactive
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Urinary Bladder Diseases
Tolterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 11, 2014