Study to Determine The Effectiveness Of Detrusitol In Patients Diagnosed With OAB

A Global Phase IV, Double-Blind, Placebo-Controlled, Randomized Trial To Evaluate The Effectiveness Of Detrusitol Sr 4mg On Patient's Perception Of Bladder Condition (PPBC).

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00143377

Enrollment

600

Registered

2005-09-02

Start date

2004-09-30

Completion date

2005-10-31

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 purpose of this study is to evaluate the effectiveness of Detrusitol (tolterodine tartrate) SR, 4 mg once daily, on patient's perception of the symptoms of overactive bladder and which of these bothersome symptoms are improved with treatment.

Interventions

DRUGtolterodine SR, overactive bladder

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* 18 years or older patients suffering from OAB symptoms (urinary frequency of at least 8 micturitions per 24h, urinary urgency and at least 3 urge urinary incontinence episodes within 3 days), confirmed by a micturition bladder diary.

Exclusion criteria

* Other than urge incontinence * History of prostate/uterine or other female organ cancer

Design outcomes

Primary

Measure	Time frame
Patient Perception of Bladder Condition at 12 weeks of treatment compared to placebo.	—

Secondary

Measure	Time frame
Other safety and efficacy measures at 12 weeks of treatment.	—

Outcome results

None listed

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