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

Viatris

Status and phase

Completed

Phase 4

Conditions

Urinary Incontinence

Treatments

Drug: Placebo

Drug: Tolterodine ER

Study type

Interventional

Funder types

Industry

Identifiers

NCT00137397

A6121006

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No 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)