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A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder

10. december 2012 opdateret af: Pfizer

A 12-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Vulnerable Elderly Patients With Overactive Bladder.

This study is designed to assess the efficacy and safety of a flexible dose regimen of fesoterodine on urgency urinary incontinence (UUI) episodes in vulnerable elderly subjects with overactive bladder (OAB).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

566

Fase

  • Fase 4

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35233
        • Pfizer Investigational Site
      • Birmingham, Alabama, Forenede Stater, 35294
        • Pfizer Investigational Site
      • Montgomery, Alabama, Forenede Stater, 36117
        • Pfizer Investigational Site
    • Arizona
      • Green Valley, Arizona, Forenede Stater, 85614
        • Pfizer Investigational Site
      • Mesa, Arizona, Forenede Stater, 85206-1734
        • Pfizer Investigational Site
      • Phoenix, Arizona, Forenede Stater, 85032
        • Pfizer Investigational Site
      • Tucson, Arizona, Forenede Stater, 85712
        • Pfizer Investigational Site
      • Tuscon, Arizona, Forenede Stater, 85710
        • Pfizer Investigational Site
    • Arkansas
      • Little Rock, Arkansas, Forenede Stater, 72223
        • Pfizer Investigational Site
      • Little Rock, Arkansas, Forenede Stater, 72204
        • Pfizer Investigational Site
    • California
      • Costa Mesa, California, Forenede Stater, 92626
        • Pfizer Investigational Site
      • Fairfield, California, Forenede Stater, 94534
        • Pfizer Investigational Site
      • Glendora, California, Forenede Stater, 91741
        • Pfizer Investigational Site
      • La Mesa, California, Forenede Stater, 91942
        • Pfizer Investigational Site
      • Long Beach, California, Forenede Stater, 90806
        • Pfizer Investigational Site
      • Mission Viejo, California, Forenede Stater, 92691
        • Pfizer Investigational Site
      • Murrieta, California, Forenede Stater, 92562
        • Pfizer Investigational Site
      • Norwalk, California, Forenede Stater, 90650
        • Pfizer Investigational Site
      • Paramount, California, Forenede Stater, 90723
        • Pfizer Investigational Site
      • Rancho Santa Margarita, California, Forenede Stater, 92688
        • Pfizer Investigational Site
      • San Bernardino, California, Forenede Stater, 92404
        • Pfizer Investigational Site
      • San Diego, California, Forenede Stater, 92108
        • Pfizer Investigational Site
      • Santa Ana, California, Forenede Stater, 92705
        • Pfizer Investigational Site
      • Temecula, California, Forenede Stater, 92591
        • Pfizer Investigational Site
      • Vacaville, California, Forenede Stater, 95688
        • Pfizer Investigational Site
    • Colorado
      • Aurora, Colorado, Forenede Stater, 80012
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, Forenede Stater, 80907
        • Pfizer Investigational Site
      • Colorado Springs, Colorado, Forenede Stater, 80909
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80220
        • Pfizer Investigational Site
      • Denver, Colorado, Forenede Stater, 80211
        • Pfizer Investigational Site
      • Englewood, Colorado, Forenede Stater, 80113
        • Pfizer Investigational Site
      • Englewood, Colorado, Forenede Stater, 80110
        • Pfizer Investigational Site
      • Longmont, Colorado, Forenede Stater, 80501
        • Pfizer Investigational Site
      • Parker, Colorado, Forenede Stater, 80134
        • Pfizer Investigational Site
    • Connecticut
      • Groton, Connecticut, Forenede Stater, 06340
        • Pfizer Investigational Site
      • Milford, Connecticut, Forenede Stater, 06460
        • Pfizer Investigational Site
      • New London, Connecticut, Forenede Stater, 06320
        • Pfizer Investigational Site
    • Florida
      • Bonita Springs, Florida, Forenede Stater, 34134
        • Pfizer Investigational Site
      • Boynton Beach, Florida, Forenede Stater, 33472
        • Pfizer Investigational Site
      • Brooksville, Florida, Forenede Stater, 34601
        • Pfizer Investigational Site
      • Clearwater, Florida, Forenede Stater, 33756
        • Pfizer Investigational Site
      • Daytona Beach, Florida, Forenede Stater, 32114
        • Pfizer Investigational Site
      • DeLand, Florida, Forenede Stater, 32720
        • Pfizer Investigational Site
      • Ft. Lauderdale, Florida, Forenede Stater, 33316
        • Pfizer Investigational Site
      • Lake Worth, Florida, Forenede Stater, 33461
        • Pfizer Investigational Site
      • Melbourne, Florida, Forenede Stater, 32901
        • Pfizer Investigational Site
      • Naples, Florida, Forenede Stater, 34102
        • Pfizer Investigational Site
      • New Port Richey, Florida, Forenede Stater, 34655
        • Pfizer Investigational Site
      • New Port Richey, Florida, Forenede Stater, 34652
        • Pfizer Investigational Site
      • Ocala, Florida, Forenede Stater, 34471
        • Pfizer Investigational Site
      • Plant City, Florida, Forenede Stater, 33563
        • Pfizer Investigational Site
      • Sarasota, Florida, Forenede Stater, 34237
        • Pfizer Investigational Site
      • St. Petersburg, Florida, Forenede Stater, 33710
        • Pfizer Investigational Site
      • Trinity, Florida, Forenede Stater, 34655
        • Pfizer Investigational Site
      • Wellington, Florida, Forenede Stater, 33449
        • Pfizer Investigational Site
      • Winter Haven, Florida, Forenede Stater, 33880
        • Pfizer Investigational Site
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30067
        • Pfizer Investigational Site
      • Macon, Georgia, Forenede Stater, 31217
        • Pfizer Investigational Site
    • Illinois
      • Springfield, Illinois, Forenede Stater, 62702
        • Pfizer Investigational Site
      • Springfield, Illinois, Forenede Stater, 62703
        • Pfizer Investigational Site
    • Indiana
      • Newburgh, Indiana, Forenede Stater, 47630
        • Pfizer Investigational Site
    • Kansas
      • Arkansas City, Kansas, Forenede Stater, 67005
        • Pfizer Investigational Site
      • Kansas City, Kansas, Forenede Stater, 66160-7390
        • Pfizer Investigational Site
      • Wichita, Kansas, Forenede Stater, 67207
        • Pfizer Investigational Site
      • Wichita, Kansas, Forenede Stater, 67205
        • Pfizer Investigational Site
    • Kentucky
      • Lexington, Kentucky, Forenede Stater, 40504
        • Pfizer Investigational Site
      • Lexington, Kentucky, Forenede Stater, 40503
        • Pfizer Investigational Site
    • Louisiana
      • Shreveport, Louisiana, Forenede Stater, 71106
        • Pfizer Investigational Site
    • Maryland
      • Baltimore, Maryland, Forenede Stater, 21211
        • Pfizer Investigational Site
      • Glen Burnie, Maryland, Forenede Stater, 21061
        • Pfizer Investigational Site
      • Towson, Maryland, Forenede Stater, 21204
        • Pfizer Investigational Site
    • Massachusetts
      • Springfield, Massachusetts, Forenede Stater, 01103
        • Pfizer Investigational Site
    • Michigan
      • Grand Rapids, Michigan, Forenede Stater, 49503
        • Pfizer Investigational Site
      • Kalamazoo, Michigan, Forenede Stater, 49009
        • Pfizer Investigational Site
    • Minnesota
      • Edina, Minnesota, Forenede Stater, 55435
        • Pfizer Investigational Site
    • Mississippi
      • Picayune, Mississippi, Forenede Stater, 39466
        • Pfizer Investigational Site
      • Southaven, Mississippi, Forenede Stater, 38671
        • Pfizer Investigational Site
    • Missouri
      • St. Louis, Missouri, Forenede Stater, 63117
        • Pfizer Investigational Site
    • Nebraska
      • Lincoln, Nebraska, Forenede Stater, 68516
        • Pfizer Investigational Site
      • Omaha, Nebraska, Forenede Stater, 68114
        • Pfizer Investigational Site
    • Nevada
      • Las Vegas, Nevada, Forenede Stater, 89119
        • Pfizer Investigational Site
    • New Jersey
      • Moorestown, New Jersey, Forenede Stater, 08057
        • Pfizer Investigational Site
      • Sewell, New Jersey, Forenede Stater, 08080
        • Pfizer Investigational Site
    • New York
      • Albany, New York, Forenede Stater, 12208
        • Pfizer Investigational Site
      • Brooklyn, New York, Forenede Stater, 11215
        • Pfizer Investigational Site
      • Staten Island, New York, Forenede Stater, 10304
        • Pfizer Investigational Site
      • Williamsville, New York, Forenede Stater, 14221
        • Pfizer Investigational Site
    • North Carolina
      • Cary, North Carolina, Forenede Stater, 27518
        • Pfizer Investigational Site
      • Cary, North Carolina, Forenede Stater, 27511
        • Pfizer Investigational Site
      • Raleigh, North Carolina, Forenede Stater, 27612
        • Pfizer Investigational Site
    • Ohio
      • Willoughby Hills, Ohio, Forenede Stater, 44094
        • Pfizer Investigational Site
    • Oklahoma
      • Bethany, Oklahoma, Forenede Stater, 73008
        • Pfizer Investigational Site
      • Norman, Oklahoma, Forenede Stater, 73069
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Forenede Stater, 73112
        • Pfizer Investigational Site
      • Oklahoma City, Oklahoma, Forenede Stater, 73109
        • Pfizer Investigational Site
    • Oregon
      • Portland, Oregon, Forenede Stater, 97205
        • Pfizer Investigational Site
    • Pennsylvania
      • Altoona, Pennsylvania, Forenede Stater, 16602
        • Pfizer Investigational Site
      • Erie, Pennsylvania, Forenede Stater, 16507
        • Pfizer Investigational Site
      • Pittsburgh, Pennsylvania, Forenede Stater, 15243
        • Pfizer Investigational Site
    • Rhode Island
      • East Providence, Rhode Island, Forenede Stater, 02914
        • Pfizer Investigational Site
      • East Providence, Rhode Island, Forenede Stater, 02915
        • Pfizer Investigational Site
    • South Carolina
      • Charleston, South Carolina, Forenede Stater, 29425
        • Pfizer Investigational Site
      • Columbia, South Carolina, Forenede Stater, 29201
        • Pfizer Investigational Site
      • Myrtle Beach, South Carolina, Forenede Stater, 29572
        • Pfizer Investigational Site
    • Tennessee
      • Bristol, Tennessee, Forenede Stater, 37620
        • Pfizer Investigational Site
      • Chattanooga, Tennessee, Forenede Stater, 37404
        • Pfizer Investigational Site
      • Jackson, Tennessee, Forenede Stater, 38305
        • Pfizer Investigational Site
      • Memphis, Tennessee, Forenede Stater, 38119
        • Pfizer Investigational Site
    • Texas
      • Austin, Texas, Forenede Stater, 78745
        • Pfizer Investigational Site
      • Austin, Texas, Forenede Stater, 78757
        • Pfizer Investigational Site
      • Corpus Christi, Texas, Forenede Stater, 78414
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77074
        • Pfizer Investigational Site
      • Houston, Texas, Forenede Stater, 77062
        • Pfizer Investigational Site
      • Leander, Texas, Forenede Stater, 78641
        • Pfizer Investigational Site
      • Longview, Texas, Forenede Stater, 75605
        • Pfizer Investigational Site
      • Longview, Texas, Forenede Stater, 75601
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78229
        • Pfizer Investigational Site
      • San Antonio, Texas, Forenede Stater, 78216
        • Pfizer Investigational Site
      • Temple, Texas, Forenede Stater, 76508
        • Pfizer Investigational Site
    • Utah
      • Murray, Utah, Forenede Stater, 84107
        • Pfizer Investigational Site
      • Salt Lake City, Utah, Forenede Stater, 84103
        • Pfizer Investigational Site
      • West Jordan, Utah, Forenede Stater, 84088
        • Pfizer Investigational Site
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23229
        • Pfizer Investigational Site
    • Washington
      • Burien, Washington, Forenede Stater, 98166
        • Pfizer Investigational Site
      • Spokane, Washington, Forenede Stater, 99216
        • Pfizer Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • male or female subjects 65 years of age or older
  • OAB symptoms for at least 3 months
  • score 3 or greater on Vulnerable Elderly Survey (VES-13)
  • adequate mobility for independent toileting
  • mean number of at least 2 UUI episodes per 24 hours
  • mean urinary frequency of 8 or more micturitions per 24 hours
  • able to independently complete the bladder diaries

Exclusion Criteria:

  • PVR urinary volume greater than 200 ml
  • MMSE score less than 20
  • greater than 15 UUI episodes per 24 hours
  • creatinine clearance less than 30 ml/min
  • an average resting heart rate of greater than or equal to 90 beats per minute

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Placebo
Medicin: Placebo
Placebo sham 4 mg and 8 mg
Eksperimentel: Fesoterodin
Medicin: Fesoterodine
Fesoterodine 4 mg and 8 mg

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Tidsramme: Baseline
UUI episodes were defined as those with the Urinary Sensation Scale (USS) rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Baseline
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 12
Tidsramme: Baseline, Week 12
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Baseline, Week 12

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Overaktiv blære-spørgeskema (OAB-q) Symptom Besvær-score
Tidsramme: Baseline
OAB-q: et selvadministreret spørgeskema med 33 punkter, der vurderer, hvor meget deltageren har været generet af udvalgte blæresymptomer. Hvert element vurderet af deltageren på Likert skala 1 (mindst symptom gener) til 6 (mest symptom gener). Symptom generende score udledt som summen af ​​score for spørgsmål 1-8; lavest mulige råscore: 8; højest mulige score: 48. Data analyseret baseret på transformation af scoren til en skala fra 0 til 100 [(Faktisk total råscore - lavest mulige værdi af råscore)/område]*100. Højere scoreværdier indikerer større symptomgener.
Baseline
Sundhedsrelateret livskvalitet (HRQL) domæne og total score for overaktiv blære spørgeskema (OAB-q)
Tidsramme: Baseline
OAB-q: selvadministreret, 33 punkter, spørgeskema, vurderer, hvor meget deltager har været generet af udvalgte blæresymptomer. Hvert emne vurderes på Likert-skalaen 1 (mindst generende symptomer) til 6 (mest generende symptomer). Spørgsmål 9 til 33 udgør HRQL, omfatter domæner: bekymring, mestring, søvn og social funktion. HRQL-domæne og total råscore udledt som summen af ​​scores. Transformeret scoreområde 0 til 100 (Total HRQL eller domæne) = [(Højest mulige råscore-Faktisk samlet råscore)/Råscoreinterval]*100. Højere transformerede score indikerer bedre HRQL.
Baseline
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4
Tidsramme: Baseline, Week 4
UUI episodes were defined as those with the USS rating of 5 in the diary. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Baseline, Week 4
Percent Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Percent change of UUI episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4, 12
Mean Number of Micturitions Per 24 Hours
Tidsramme: Baseline
Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Baseline
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Micturitions include episodes of voluntary micturition and episodes of UUI. UUI episodes were defined as those micturitions with USS rating of 5 in the diary in participants with UUI at baseline. USS rating 5: Unable to hold; leak urine.
Baseline, Week 4, 12
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Percent change of micturitions per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4, 12
Mean Number of Micturition-related Urgency Episodes Per 24 Hours
Tidsramme: Baseline
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Baseline
Change From Baseline in Mean Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
The mean number of micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 3 divided by the total number of days that diary data was collected at that visit. USS total range 1 to 5: 1. No feeling of urgency, 2. Mild feeling of urgency, 3. Moderate feeling of urgency, 4. Severe feeling of urgency, 5. Unable to hold; leak urine.
Baseline, Week 4, 12
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Percent change of micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4, 12
Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours
Tidsramme: Baseline
Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Baseline
Change From Baseline in Mean Number of Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Nocturnal micturition-related urgency episodes had USS rating of 3 or more that occurred between time participant went to bed and time he or she arose to start next day. Number of nocturnal micturition-related urgency episodes per 24 hours was calculated as sum of all nocturnal micturition-related urgency episodes divided by total number of diary days collected at that visit.
Baseline, Week 4, 12
Percent Change From Baseline in Nocturnal Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Percent change of nocturnal micturition-related urgency episodes per 24 hours was calculated as change in 24-hour mean at that visit divided by the baseline 24-hour mean multiplied by 100 (i.e., 100*(Week 4 or 12 - baseline)/baseline).
Baseline, Week 4, 12
Frequency-Urgency Sum Rating Per 24 Hours
Tidsramme: Baseline
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine.
Baseline
Change From Baseline in Frequency-Urgency Sum Rating Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Frequency-urgency sum is total USS ratings recorded for all micturitions in 24-hour day. Number of USS ratings per 24 hours is sum of all USS ratings divided by the total diary days collected at that visit. USS scale: 1=No feeling of urgency to 5=Unable to hold: leak urine. Numerical decrease indicates improvement.
Baseline, Week 4, 12
Change From Baseline in Mean Number of Protective Undergarments Changed Due to Urinary Leakage Per 24 Hours at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
Protective Undergarments included pads, protective padding, protective underwear (pull up), and briefs (diaper). The mean number of undergarments changed per 24 hours was calculated as the total number of undergarments changed divided by the total number of diary days collected at that visit. Change from baseline values were reported at week 4 for subsets of population with baseline values less than or equal to (=<) 3.5 and more than (>) 3.5 undergarments/day and at Week 12 for subsets of population with baseline values =< 2.5 and > 2.5 undergarments/day.
Baseline, Week 4, 12
Percentage of Participants With Change From Screening in Patient Perception of Bladder Condition (PPBC) at Week 4 and 12
Tidsramme: Screening, Week 4, 12
PPBC: a self-administered, single-item, questionnaire that asks participants to describe their perception of their bladder-related problems. The PPBC assessment is rated on a 6-point scale: 1=no problems at all, 2=some very minor problems, 3=some minor problems, 4=moderate problems, 5=severe problems, 6=many severe problems. Deterioration=score difference is greater than 0; no change=score difference is 0; minor improvement=score difference is -1; major difference=score difference is less than or equal to -2.
Screening, Week 4, 12
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
OAB-q: a self-administered, 33-item, questionnaire that assesses how much the participant has been bothered by selected bladder symptoms. Each item rated by participant on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Symptom bother score derived as sum of scores for questions 1-8; lowest possible raw score: 8; highest possible score: 48. Data analyzed based on transformation of the score to a 0 to 100 scale [(Actual total raw score - lowest possible value of raw score)/range]*100. Higher scores values indicative of greater symptom bother.
Baseline, Week 4, 12
Change From Baseline in Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
OAB-q: self-administered, 33-item, questionnaire, assesses how much participant has been bothered by selected bladder symptoms. Each item rated on Likert scale 1 (least symptom bother) to 6 (most symptom bother). Questions 9 to 33 constitute HRQL, includes domains: concern, coping, sleep, and social function. HRQL domain and total raw score derived as sum of scores. Transformed score range 0 to 100 (Total HRQL or domain) = [(Highest possible raw score-Actual total raw score)/Raw score range]*100. Higher transformed scores indicative of better HRQL.
Baseline, Week 4, 12
Overactive Bladder Satisfaction Questionnaire (OAB-S) Total Score on Satisfaction With OAB Control
Tidsramme: Week 12
OAB-S: a validated self-administered instrument that evaluates OAB medication expectations, daily life with AB, and satisfaction with OAB medication and includes 3 stand-alone items that assess overall expectation, satisfaction, and willingness to continue treatment. Satisfaction coded on scale of 1 to 5: (1=very satisfied to 5=very dissatisfied). Coding reversed algorithmically and results transformed: total score range 0 to100. Higher final response value associated with better satisfaction.
Week 12
Percentage of Participants With Overactive Bladder Satisfaction Questionnaire (OAB-S) Global Medication Satisfaction Question Response
Tidsramme: Week 12
Participant's response to question, "overall, how satisfied are you with your OAB medication?" was obtained on a 5 point scale, 1- very satisfied, 2- somewhat satisfied, 3- neither dissatisfied nor satisfied, 4- somewhat dissatisfied and 5- very dissatisfied. Response values 1 and 2 were combined into "satisfied", and 4 and 5 were combined into "dissatisfied".
Week 12
Mini Mental State Examination (MMSE)
Tidsramme: Screening
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state.
Screening
Change From Screening in Mini Mental State Examination (MMSE) Score at Week 12
Tidsramme: Screening, Week 12
MMSE measured general cognitive functioning: orientation, memory, attention, calculation, language, visuospatial functions. Total score derived from sub-scores; total ranges from 0 to 30, higher score indicates better cognitive state. Change: mean score at Week X minus mean score at baseline
Screening, Week 12
Change From Baseline in Post Void Residual (PVR) Volume at Week 4 and 12
Tidsramme: Baseline, Week 4, 12
PVR volume is defined as volume of urine remaining in the bladder immediately after urination.
Baseline, Week 4, 12

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2009

Primær færdiggørelse (Faktiske)

1. september 2011

Studieafslutning (Faktiske)

1. september 2011

Datoer for studieregistrering

Først indsendt

24. juni 2009

Først indsendt, der opfyldte QC-kriterier

24. juni 2009

Først opslået (Skøn)

25. juni 2009

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

17. januar 2013

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

10. december 2012

Sidst verificeret

1. december 2012

Mere information

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Andre undersøgelses-id-numre

  • A0221049

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