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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

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NCT00137397

Last updated on August 9, 2018
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FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Blackburn, Lancashire, BB2 3HH United Kingdom
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urinary Incontinence
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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)

NCT00137397
Pfizer
Completed
A Study to Measure the Effect of Tolterodine Extended Release on the Thickness of the Bladder Wall in Patients With Overactive Bladder

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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
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.
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.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Urinary Incontinence
  • Drug: Tolterodine ER
  • Drug: Placebo
Not Provided
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
August 2006
Not Provided

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)
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
 
NCT00137397
A6121006
Not Provided
Not Provided
Not Provided
Not Provided
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2006

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

FOR MORE INFORMATION

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