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

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ClinicalTrials.gov Identifier: NCT00862745
Recruitment Status : Completed
First Posted : March 17, 2009
Results First Posted : November 24, 2011
Last Update Posted : November 24, 2011
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Jeanette Brown, University of California, San Francisco

Brief Summary:

Six hundred and thirty-six women diagnosed with urge urinary incontinence (UUI) by a three-item self-administered questionnaire (3IQ) will be randomized to 12 weeks of fesoterodine or matching placebo. The study will take place at up to 14 clinical sites in the US. All participants who complete the 12-week randomized trial will be offered open-label fesoterodine for an additional 9 months.

The hypothesis of the randomized controlled trial is that among women diagnosed with urge incontinence using the 3IQ, fesoterodine is more effective than placebo in reducing the mean number of urge incontinence episodes per day.


Condition or disease Intervention/treatment Phase
Urge Urinary Incontinence Overactive Bladder Drug: Fesoterodine Drug: Matching Placebo Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 645 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Multi-center, Randomized, Placebo-controlled Clinical Trial Comparing Fesoterodine to Placebo in Women Diagnosed With Urge Urinary Incontinence by the 3 Incontinence Questions (3IQ). Followed by a Multi-center Open Label Clinical Cohort Study of Long-term Effects of Treatment With Fesoterodine.
Study Start Date : January 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Active
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
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.

Placebo Comparator: Control
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
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.




Primary Outcome Measures :
  1. Change in Frequency of Urge Urinary Incontinence Episodes at Week 12. [ Time Frame: Baseline and Week 12 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ambulatory females ≥ 18 years old
  • Urge Urinary Incontinence (subject-reported) for ≥ 3 months prior to Screening (Visit 1)
  • On the 3IQ: Response b to Question 3: During the last 3 months, did you leak urine most often: b. When you had the urge or the feeling that you needed to empty your bladder, but could not get to the toilet fast enough?
  • On a 3-day bladder diary, documentation of an average of 1 UUI episode per 24 hours (3 UUI episodes in 3 days)
  • Capability of understanding and having signed the informed consent form after full discussion of the research nature of the treatment and its risk and benefits
  • Ability to perform all procedures and tests required by the protocol
  • Willingness to remain on stable medication regime for duration of the randomized controlled trial. Participants will be asked to not add new medications during the randomized controlled trial, such as diuretics and other medications which may affect their voiding pattern.

Exclusion Criteria:

  • 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.
  • Administration of medications capable of inducing hepatic enzyme metabolism or transport (e.g., barbiturates, rifampicin, carbamazepine, phenytoin, primidone, or St. John's Wort) in the past 30 days.
  • Previously received any investigational drug within 30 days prior to trial entry.
  • Alcohol and/or any other drug abuse in the opinion of the investigator.
  • Participants who are pregnant, nursing, or with a positive urine pregnancy test or who are intending to become pregnant within 3 months after the completion of the trial.
  • Participants that have been pregnant (> 20 weeks gestation) in the previous 6 months.
  • Participants of childbearing potential who are heterosexually active but unwilling or unable to use an adequate form of contraception to prevent pregnancy during the study. Reliable contraceptive methods may include intrauterine devices (IUD), contraceptive pills of combination type, hormonal implants, injectable contraceptives or latex condoms with a spermicide.
  • Participants who have any medical (including known history of major hematological, renal, cardiovascular, or hepatic abnormalities) or psychological condition or social circumstances that would impair their ability to participate reliably in the trial, or those who may increase the risk to themselves or others by participating.
  • Participants who, in the opinion of the investigator, are not likely to complete the trial for whatever reason.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00862745


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
United States, California
University of California San Diego
San Diego, California, United States, 92093
University of California, San Francisco
San Francisco, California, United States, 94115
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
United States, New Mexico
University of New Mexico Health Sciences Center
Albuquerque, New Mexico, United States, 87131
United States, Oregon
Oregon Health and Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
University of Pennsylvania Medical Center
Philadelphia, Pennsylvania, United States, 19104
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15213
United States, Rhode Island
Women & Infants' Hospital, Division of Urogynecology
Providence, Rhode Island, United States, 02903
United States, Tennessee
University of Tennessee Health Science Center
Memphis, Tennessee, United States, 38120
United States, Texas
University of Texas Health Science Center San Antonio
San Antonio, Texas, United States, 78229
United States, Virginia
University of Virginia-Women's Midlife Health Center
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
University of California, San Francisco
Pfizer
Investigators
Principal Investigator: Jeanette S. Brown, MD University of California, San Francisco

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jeanette Brown, Professor, University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00862745     History of Changes
Other Study ID Numbers: GA0221IX
First Posted: March 17, 2009    Key Record Dates
Results First Posted: November 24, 2011
Last Update Posted: November 24, 2011
Last Verified: October 2011

Additional relevant MeSH terms:
Urinary Incontinence
Enuresis
Urinary Bladder, Overactive
Urinary Incontinence, Urge
Urination Disorders
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Behavioral Symptoms
Elimination Disorders
Mental Disorders
Urinary Bladder Diseases
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents