Efficacy, Safety, and Tolerability of Darifenacin in Patients Aged > 65 Years With Overactive Bladder

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00171184

Enrollment

400

Registered

2005-09-15

Start date

2005-04-30

Completion date

2006-06-30

Last updated

2017-05-18

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

Conditions

Overactive Bladder

Keywords

Overactive bladder, Darifenacin, M3 muscarinic receptor antagonist, elderly population

Brief summary

The objective of this study is to assess the efficacy, safety and tolerability of 12-weeks treatment with darifenacin in patients aged \>Ý 65 years with OAB.

Interventions

DRUGDarifenacin

Darifenacin 7,5 mg tablets once daily with the possibility to up-titrate to 15 mg once daily

DRUGPlacebo

Placebo tablet once daily with sham titration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Inclusion criteria

* Symptoms of OAB for at least six months prior to Visit 3 * Symptoms of OAB during the 7 day diary period immediately preceding Visit 3: * ≥ 1 UUIE on average per day and * ≥ 10 episodes of micturition on average per day

Exclusion criteria

* A total daily urinary volume \> 3000 ml or a mean volume voided per micturition of \> 300 ml as verified in the micturition diary before randomization * Post-void residual (PVR) urinary volume \> 100 ml * Clinically significant stress urinary incontinence as determined by the investigator * Clinically significant bladder outlet obstruction as determined by the investigator * Concomitant diseases in which the use of anticholinergic drugs is contraindicated, e.g. urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh B and C), severe ulcerative colitis, toxic megacolon. Other protocol inclusion /

Design outcomes

Primary

Measure	Time frame
Change from baseline in number of urge urinary incontinence episodes (UUIE) per week at week 12.	—

Secondary

Measure	Time frame
Change from baseline in : number of UUIE per week at week 1, 2 and 6, number of micturitions per day at week 1,2 and 12; number of urinary incontinence pads used per week at week 1,2,6 & 12; number of nocturnal voids per week at week 1,2,6 & 12.	—
Safety and tolerability.	—
Quality of life at week 6 and/or 12.	—

Countries

United States

Outcome results

None listed

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