A Study of Oxybutynin for the Treatment of Urge Urinary Incontinence

An Open-Label, Dose Escalating Study to Evaluate the Safety of Intravaginal Oxybutynin in Subjects With Urge Urinary Incontinence

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00749632

Acronym

FP1097-002

Enrollment

Registered

2008-09-09

Start date

2007-07-31

Completion date

2008-10-31

Last updated

2009-10-15

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

Conditions

Urinary Incontinence, Urge

Keywords

urinary incontinence, urge, urinary urge incontinence, urge incontinence, over active bladder

Brief summary

The purpose of this study is to determine the safety of three doses of oxybutynin for the treatment of urge urinary incontinence.

Interventions

DRUGoxybutynin

low dose oxybutynin administered daily

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Females 18 to 75 years of age * Has reported symptoms of urge urinary incontinence/overactive bladder

Exclusion criteria

* Is pregnant or lactating * Has had lower urinary tract surgery within 6 months prior to Screening * Has a history of urinary retention

Design outcomes

Primary

Measure	Time frame
Number of micturations and incontinence episodes.	Two weeks pretreatment and three weeks on treatment

Countries

United States

Outcome results

None listed

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