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NCT00137397 Clinical Trial

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

Urinary Incontinence Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00137397
Other study ID # A6121006
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date November 2004
Est. completion date August 2006

Study information
Verified date January 2021
Source Pfizer
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date August 2006
Est. primary completion date
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Tolterodine ER

• Placebo

Locations
Country Name City State
United Kingdom Pfizer Investigational Site Basingstoke
United Kingdom Pfizer Investigational Site Birmingham
United Kingdom Pfizer Investigational Site Blackburn Lancashire
United Kingdom Pfizer Investigational Site Cambs
United Kingdom Pfizer Investigational Site Harrow Middx
United Kingdom Pfizer Investigational Site Livingston West Lothian
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site London
United Kingdom Pfizer Investigational Site Northampton
United Kingdom Pfizer Investigational Site Oxford Oxfordshire
United Kingdom Pfizer Investigational Site Pl6 8Dh

Sponsors (1)
Lead Sponsor Collaborator
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.
Secondary Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24
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