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.

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00137397

Enrollment

Registered

2005-08-29

Start date

2004-11-30

Completion date

2006-08-31

Last updated

2021-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Incontinence

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.

Interventions

DRUGTolterodine ER

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
The main outcome will be the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 12.	—

Secondary

Measure	Time frame
Secondary outcomes are the change in bladder wall thickness, as measured by intra-vaginal ultrasound from baseline to week 24	—

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026