Effect of Detrol LA on Overactive Bladder Symptoms, Sexual Quality of Life and Sexual Function in Women

Viatris

Status and phase

Completed

Phase 4

Conditions

Urinary Incontinence

Treatments

Drug: Tolterodine ER 4mg QD

Study type

Interventional

Funder types

Industry

Identifiers

NCT00143481

A6121002

Details and patient eligibility

About

The purpose of the study is to assess the impact of treatment with tolterodine ER versus placebo on Urgency Urinary Incontinence in sexually active women with OAB symptoms.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Female outpatients 18 years or older.
Overactive bladder symptoms (subject-reported) for greater than or equal to 3 months.
Currently sexually active with a male partner.

Exclusion criteria

Diagnosed or suspected interstitial cystitis, uninvestigated hematuria, urogenital cancer, and interstitial or external radiation to the pelvis or external genitalia or clinically significant bladder outlet obstruction.
Symptoms of incontinence being predominately stress urinary incontinence as determined by the investigator.
Treated with antimuscarinic/ anticholinergic medication, for any reason including OAB, within the last 3 months or are expected to start therapy during the study treatment period.
Any drug for urgency urinary incontinence (UUI) initiated within the past 3 months prior to Visit 1, with the exception of estrogen (topical or systemic) as long as treatment is not initiated within 4 weeks prior to Visit 1 (screening)