Trials Sponsors Conditions Drugs Pricing

Conditions

Overactive Bladder Urge Urinary Incontinence

Outcome Measures

Primary Outcomes (1)

Change in Frequency of Urge Urinary Incontinence Episodes at Week 12.
Baseline and Week 12

Study Arms (2)

Active

EXPERIMENTAL

fesoterodine 4 mg (1 tablet) for 2 weeks with the option to increase to fesoterodine 8 mg or stay at fesoterodine 4 mg for 10 weeks for a total of 12 weeks of study medication.

Drug: Fesoterodine

Control

PLACEBO COMPARATOR

placebo (an identical pill that contains no medication) 1 tablet daily for 2 weeks followed by the option to increase the placebo pill daily for 10 weeks for a total of 12 weeks of study placebo medication.

Drug: Matching Placebo

Interventions

FesoterodineDrug

Participants will be instructed to take one tablet of blinded study medication once a day, orally, for 12 weeks. They will start with a 4 mg dose of study medication and will have the option of doubling that dose after 2 or 4 weeks if they wish. At the end of the 12 week blinded trial, participants will be offered open-label fesoterodine (Toviaz™), for 9 months beginning at 4 mg with participant directed dose adjustment.

Active

Matching PlaceboDrug

Eligibility Criteria

Age18 Years+

Sexfemale

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ambulatory females ≥ 18 years old
Urge Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)

Sponsors & Collaborators

University of California, San Francisco
Otherlead
Pfizer
Industrycollaborator

Study Sites (13)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

University of California San Diego

San Diego, California, 92093, United States

University of California, San Francisco

San Francisco, California, 94115, United States

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

University of Michigan

Ann Arbor, Michigan, 48109, United States

University of New Mexico Health Sciences Center

Albuquerque, New Mexico, 87131, United States

Oregon Health and Science University

Related Publications (2)

Stoniute A, Madhuvrata P, Still M, Barron-Millar E, Nabi G, Omar MI. Oral anticholinergic drugs versus placebo or no treatment for managing overactive bladder syndrome in adults. Cochrane Database Syst Rev. 2023 May 9;5(5):CD003781. doi: 10.1002/14651858.CD003781.pub3.
PMID: 37160401DERIVED
Warsi QA, Huang AJ, Hess R, Arya LA, Richter HE, Bradley CS, Rogers RG, Myers DL, Johnson KC, Winkelman WD, Gregory WT, Kraus SR, Schembri M, Brown JS, Stone KL, Subak LL. Association of Pharmacologic Treatment of Urgency Urinary Incontinence With Sleep Quality and Daytime Sleepiness. Obstet Gynecol. 2018 Feb;131(2):204-211. doi: 10.1097/AOG.0000000000002443.
PMID: 29324595DERIVED

MeSH Terms

Conditions

Urinary Incontinence, UrgeUrinary Bladder, Overactive

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary IncontinenceUrination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title: Dr. Jeanette Brown
Organization: University of California, San Francisco

Study Officials

Jeanette S. Brown, MD
University of California, San Francisco
PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee: No
Restrictive Agreement: No

Enrollment

645 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 4
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Professor

Study Record Dates

First Submitted

March 13, 2009

First Posted

March 17, 2009

Study Start

January 2009

Date type not reported

This date has not been verified as actual or estimated.

You may not qualify if:

Any condition that would contraindicate their usage of fesoterodine including: hypersensitivity to the active drug (fesoterodine fumarate) and its ingredients or any of the excipients, history of urinary retention, gastric retention, uncontrolled narrow angle glaucoma, myasthenia gravis, severe hepatic impairment (Child Pugh C), severe ulcerative colitis, toxic megacolon, fistula or a hole in your bladder or rectum, birth defect leading to urine leakage, and urine leakage starting in childhood.
Clinically significant hepatic or renal disease.
Neurologic conditions such as stroke, multiple sclerosis, spinal cord injury, or Parkinson's disease.
Symptomatic pelvic organ prolapse defined as participant report of feeling or seeing a bulge outside the vagina within the past 3 months.
History of lower urinary tract/pelvic surgery (e.g. surgery for incontinence in the past 5 years, surgery in the past 6 months for prolapse or hysterectomy), intra-vesical therapy (botox), and/or bulk injections within the past 6 months.
A known history of interstitial cystitis or a significant pain component associated with OAB symptoms, uninvestigated hematuria, urogenital cancer, interstitial or external radiation to the pelvis or external genitalia.
Urinary tract infection (UTI) as shown by the results of the urinalysis at screening or recurrent urinary tract infection (RUTIs) defined as treatment for UTI \>3 times in the last year.
Use of any electrostimulation, bladder training, or pelvic floor exercises (with certified incontinence practitioners) within 4 weeks of Screening.
Received study medication in any previous fesoterodine clinical trial.
Prior failure for either efficacy or tolerability of ≥ 2 OAB medications in the last year. (failure: inadequate symptom control after two medications for a minimum of one month each)
Has been treated within 2 weeks prior to Screening and/or is currently being treated with: - Any drug treatment for overactive bladder, including antimuscarinic OAB medications.
Any drugs with significant anticholinergic and antispasmodic effects (see exception for tricyclic antidepressants below)
Has started treatment with tricyclic antidepressants or estrogens within 4 weeks prior to Screening and/or is not on a stable dose.
Intermittent or unstable use of diuretics. Treatment with diuretics initiated within 2 weeks prior to baseline is not permitted.
Treatment with potent CYP3A4 inhibitors, such as clarithromycin, ketoconazole, and itraconazole within 2 weeks prior to Screening.
+8 more criteria

Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Active

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Results Posted

Conditions

Outcome Measures

Primary Outcomes (1)

Study Arms (2)

Active

Control

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (13)

Related Publications (2)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Results Point of Contact

Study Officials

Publication Agreements

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations