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CompletedNCT00137397Updated Jan 27, 2021

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

A Phase 4 interventional study of Tolterodine ER and Placebo in Urinary Incontinence, sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc.. Completed at 11 sites in United Kingdom. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.

Sponsored by Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

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In context

Urinary Incontinence

1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.

This study's enrollment of 80 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.

Browse Urinary Incontinence studies →

Lead sponsor

Pfizer's Upjohn has merged with Mylan to form Viatris Inc. is the lead sponsor of 431 studies on the registry; none are open to participants now.

Of its 9 completed or terminated interventional studies of FDA-regulated products, 8 (89%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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)
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
80 participants

Interventions

  • DrugTolterodine ER
  • DrugPlacebo
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What researchers measure

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

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Study locations

11 sites
  • 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
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References and documents

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 27, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00137397
Lead sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
First posted
Aug 29, 2005
Start date
Nov 2004
Completion
Aug 2006
Last update
Jan 27, 2021

Study contacts

Pfizer CT.gov Call Center
study director · Pfizer
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.

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