A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder
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.
1 other identifier
interventional
80
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Nov 2004
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 25, 2005
CompletedFirst Posted
Study publicly available on registry
August 29, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2006
CompletedJanuary 27, 2021
January 1, 2021
August 25, 2005
January 26, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.
Secondary Outcomes (1)
Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Pfizer Investigational Site
Blackburn, Lancashire, BB2 3HH, United Kingdom
Pfizer Investigational Site
Harrow, Middx, HA1 3UJ, United Kingdom
Pfizer Investigational Site
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Pfizer Investigational Site
Livingston, West Lothian, EH54 6PP, United Kingdom
Pfizer Investigational Site
Basingstoke, RG24 9NA, United Kingdom
Pfizer Investigational Site
Birmingham, B15 2TG, United Kingdom
Pfizer Investigational Site
Cambs, PE18 8NT, United Kingdom
Pfizer Investigational Site
London, SE5 9RS, United Kingdom
Pfizer Investigational Site
London, W2 2YP, United Kingdom
Pfizer Investigational Site
Northampton, NN1 5BD, United Kingdom
Pfizer Investigational Site
Pl6 8Dh, United Kingdom
Related Publications (1)
Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
August 25, 2005
First Posted
August 29, 2005
Study Start
November 1, 2004
Study Completion
August 1, 2006
Last Updated
January 27, 2021
Record last verified: 2021-01