A Double-Blind, Paralleled Study Comparing Efficacy/Safety of Solifenacin to Tolterodine in Overactive Bladder Patients

A Randomized, Double-Blind, Paralleled, Active Controlled, Multi-Center Study of the Efficacy and Safety of 5mg Solifenacin Succinate Compared to Tolterodine in Patients With Overactive Bladder

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00368706

Enrollment

246

Registered

2006-08-25

Start date

2006-09-30

Completion date

2008-03-31

Last updated

2008-04-10

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

Conditions

Urinary Bladder, Overactive

Keywords

solifenacin, Overactive bladder, Urinary incontinence, Treatment outcomes, VESIcare

Brief summary

To evaluate the efficacy and safety of solifenacin succinate (Vesicare) 5mg OD in subjects with overactive bladder compared to tolterodine wmg, bid

Interventions

DRUGsolifenacin succinate

Oral

DRUGtolterodine

oral

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Patients willing and able to complete the micturition diary correctly * Patients experiencing frequency of micturition as verified in the diary * Patients experiencing significant post void residual volume * OAB symptoms including urinary frequency, urgency or urge incontinence for 3 months or more.

Exclusion criteria

* Significant post void residual volume * Patients with indwelling catheters or practicing intermittent self- catheterization * Known or suspected hypersensitivity to solifenacin succinate or other anticholinergics or lactose

Design outcomes

Primary

Measure	Time frame
Change from baseline in mean number of micturitions per 24 hours	8 Weeks

Secondary

Measure	Time frame
Change from baseline in mean urgency frequency per 24 hours	8 Weeks
Change from baseline in mean nocturia episodes per 24 hours	8 Weeks
Change from baseline in mean volume voided per micturition	8 Weeks
Change from baseline in mean number of incontinence episodes per 24 hours	8 Weeks

Countries

China

Outcome results

None listed

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