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:
Pfizer
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00137397
First received: August 25, 2005
Last updated: October 5, 2006
Last verified: October 2006
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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
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 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 |
ClinicalTrials.gov processed this record on May 21, 2013