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

NCT00862745

Last updated date
Study Location
University of Alabama at Birmingham
Birmingham, Alabama, 35233, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Urge Urinary Incontinence, Overactive Bladder
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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.

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Urge Urinary Incontinence, Overactive BladderBringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
NCT00862745
  1. Birmingham, Alabama
  2. San Diego, California
  3. San Francisco, California
  4. Iowa City, Iowa
  5. Ann Arbor, Michigan
  6. Albuquerque, New Mexico
  7. Portland, Oregon
  8. Philadelphia, Pennsylvania
  9. Pittsburgh, Pennsylvania
  10. Providence, Rhode Island
  11. Memphis, Tennessee
  12. San Antonio, Texas
  13. Charlottesville, Virginia
Female
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Bringing Simple Urge Incontinence Diagnosis & Treatment to Providers (BRIDGES)
Official Title  ICMJE 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.
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE
  • Urge Urinary Incontinence
  • Overactive Bladder
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Fesoterodine
  • 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.
    Intervention: Drug: Matching Placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 12, 2010)
645
Original Estimated Enrollment  ICMJE
 (submitted: March 16, 2009)
636
Actual Study Completion Date  ICMJE May 2011
Actual Primary Completion Date May 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00862745
Other Study ID Numbers  ICMJE GA0221IX
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeanette Brown, University of California, San Francisco
Study Sponsor  ICMJE University of California, San Francisco
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Jeanette S. Brown, MDUniversity of California, San Francisco
PRS Account University of California, San Francisco
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP