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 IV

Further Study Details: 

Primary Outcomes: The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.
Secondary Outcomes: Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24; the change in the average number of times a day the patient needs to use the toilet; the change in the volume of urine produced; the change in the average number of times a day the patient needs to use the toilet; the change in the volume of urine produced
Expected Total Enrollment:  80

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Female

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)

Please refer to this study by ClinicalTrials.gov identifier  NCT00137397

Pfizer CT.gov Call Center      1-800-718-1021 

United Kingdom
      Pfizer Investigational Site, London,  W2 2YP,  United Kingdom; Recruiting
      Pfizer Investigational Site, Liverpool,  L8 7SS,  United Kingdom; Recruiting
      Pfizer Investigational Site, London,  SE5 9RS,  United Kingdom; Recruiting
      Pfizer Investigational Site, Pl6 8Dh,  United Kingdom; Recruiting
      Pfizer Investigational Site, Basingstoke,  RG24 9NA,  United Kingdom; Recruiting
      Pfizer Investigational Site, Northampton,  NN1 5BD,  United Kingdom; Recruiting
      Pfizer Investigational Site, Cambs,  PE18 8NT,  United Kingdom; Recruiting
United Kingdom, Kent
      Pfizer Investigational Site, Folkstone,  Kent,  CT19 5BN,  United Kingdom; No longer recruiting
United Kingdom, Lancashire
      Pfizer Investigational Site, Blackburn,  Lancashire,  BB2 3HH,  United Kingdom; Recruiting
United Kingdom, Middx
      Pfizer Investigational Site, Harrow,  Middx,  HA1 3UJ,  United Kingdom; Recruiting
United Kingdom, Oxfordshire
      Pfizer Investigational Site, Oxford,  Oxfordshire,  OX3 9DU,  United Kingdom; Recruiting
United Kingdom, West Lothian
      Pfizer Investigational Site, Livingston,  West Lothian,  EH54 6PP,  United Kingdom; Recruiting

Study chairs or principal investigators

Pfizer CT.gov Call Center,  Study Director,  Pfizer   

Study ID Numbers:  A6121006
Last Updated:  August 29, 2005
Record first received:  August 25, 2005
ClinicalTrials.gov Identifier:  NCT00137397
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-08-30