A Study Of Efficacy And Safety Of Fesoterodine In Vulnerable Elderly Subjects With Overactive Bladder
10 décembre 2012 mis à jour par: 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).
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
566
Phase
- Phase 4
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
-
-
Alabama
-
Birmingham, Alabama, États-Unis, 35233
- Pfizer Investigational Site
-
Birmingham, Alabama, États-Unis, 35294
- Pfizer Investigational Site
-
Montgomery, Alabama, États-Unis, 36117
- Pfizer Investigational Site
-
-
Arizona
-
Green Valley, Arizona, États-Unis, 85614
- Pfizer Investigational Site
-
Mesa, Arizona, États-Unis, 85206-1734
- Pfizer Investigational Site
-
Phoenix, Arizona, États-Unis, 85032
- Pfizer Investigational Site
-
Tucson, Arizona, États-Unis, 85712
- Pfizer Investigational Site
-
Tuscon, Arizona, États-Unis, 85710
- Pfizer Investigational Site
-
-
Arkansas
-
Little Rock, Arkansas, États-Unis, 72223
- Pfizer Investigational Site
-
Little Rock, Arkansas, États-Unis, 72204
- Pfizer Investigational Site
-
-
California
-
Costa Mesa, California, États-Unis, 92626
- Pfizer Investigational Site
-
Fairfield, California, États-Unis, 94534
- Pfizer Investigational Site
-
Glendora, California, États-Unis, 91741
- Pfizer Investigational Site
-
La Mesa, California, États-Unis, 91942
- Pfizer Investigational Site
-
Long Beach, California, États-Unis, 90806
- Pfizer Investigational Site
-
Mission Viejo, California, États-Unis, 92691
- Pfizer Investigational Site
-
Murrieta, California, États-Unis, 92562
- Pfizer Investigational Site
-
Norwalk, California, États-Unis, 90650
- Pfizer Investigational Site
-
Paramount, California, États-Unis, 90723
- Pfizer Investigational Site
-
Rancho Santa Margarita, California, États-Unis, 92688
- Pfizer Investigational Site
-
San Bernardino, California, États-Unis, 92404
- Pfizer Investigational Site
-
San Diego, California, États-Unis, 92108
- Pfizer Investigational Site
-
Santa Ana, California, États-Unis, 92705
- Pfizer Investigational Site
-
Temecula, California, États-Unis, 92591
- Pfizer Investigational Site
-
Vacaville, California, États-Unis, 95688
- Pfizer Investigational Site
-
-
Colorado
-
Aurora, Colorado, États-Unis, 80012
- Pfizer Investigational Site
-
Colorado Springs, Colorado, États-Unis, 80907
- Pfizer Investigational Site
-
Colorado Springs, Colorado, États-Unis, 80909
- Pfizer Investigational Site
-
Denver, Colorado, États-Unis, 80220
- Pfizer Investigational Site
-
Denver, Colorado, États-Unis, 80211
- Pfizer Investigational Site
-
Englewood, Colorado, États-Unis, 80113
- Pfizer Investigational Site
-
Englewood, Colorado, États-Unis, 80110
- Pfizer Investigational Site
-
Longmont, Colorado, États-Unis, 80501
- Pfizer Investigational Site
-
Parker, Colorado, États-Unis, 80134
- Pfizer Investigational Site
-
-
Connecticut
-
Groton, Connecticut, États-Unis, 06340
- Pfizer Investigational Site
-
Milford, Connecticut, États-Unis, 06460
- Pfizer Investigational Site
-
New London, Connecticut, États-Unis, 06320
- Pfizer Investigational Site
-
-
Florida
-
Bonita Springs, Florida, États-Unis, 34134
- Pfizer Investigational Site
-
Boynton Beach, Florida, États-Unis, 33472
- Pfizer Investigational Site
-
Brooksville, Florida, États-Unis, 34601
- Pfizer Investigational Site
-
Clearwater, Florida, États-Unis, 33756
- Pfizer Investigational Site
-
Daytona Beach, Florida, États-Unis, 32114
- Pfizer Investigational Site
-
DeLand, Florida, États-Unis, 32720
- Pfizer Investigational Site
-
Ft. Lauderdale, Florida, États-Unis, 33316
- Pfizer Investigational Site
-
Lake Worth, Florida, États-Unis, 33461
- Pfizer Investigational Site
-
Melbourne, Florida, États-Unis, 32901
- Pfizer Investigational Site
-
Naples, Florida, États-Unis, 34102
- Pfizer Investigational Site
-
New Port Richey, Florida, États-Unis, 34655
- Pfizer Investigational Site
-
New Port Richey, Florida, États-Unis, 34652
- Pfizer Investigational Site
-
Ocala, Florida, États-Unis, 34471
- Pfizer Investigational Site
-
Plant City, Florida, États-Unis, 33563
- Pfizer Investigational Site
-
Sarasota, Florida, États-Unis, 34237
- Pfizer Investigational Site
-
St. Petersburg, Florida, États-Unis, 33710
- Pfizer Investigational Site
-
Trinity, Florida, États-Unis, 34655
- Pfizer Investigational Site
-
Wellington, Florida, États-Unis, 33449
- Pfizer Investigational Site
-
Winter Haven, Florida, États-Unis, 33880
- Pfizer Investigational Site
-
-
Georgia
-
Atlanta, Georgia, États-Unis, 30067
- Pfizer Investigational Site
-
Macon, Georgia, États-Unis, 31217
- Pfizer Investigational Site
-
-
Illinois
-
Springfield, Illinois, États-Unis, 62702
- Pfizer Investigational Site
-
Springfield, Illinois, États-Unis, 62703
- Pfizer Investigational Site
-
-
Indiana
-
Newburgh, Indiana, États-Unis, 47630
- Pfizer Investigational Site
-
-
Kansas
-
Arkansas City, Kansas, États-Unis, 67005
- Pfizer Investigational Site
-
Kansas City, Kansas, États-Unis, 66160-7390
- Pfizer Investigational Site
-
Wichita, Kansas, États-Unis, 67207
- Pfizer Investigational Site
-
Wichita, Kansas, États-Unis, 67205
- Pfizer Investigational Site
-
-
Kentucky
-
Lexington, Kentucky, États-Unis, 40504
- Pfizer Investigational Site
-
Lexington, Kentucky, États-Unis, 40503
- Pfizer Investigational Site
-
-
Louisiana
-
Shreveport, Louisiana, États-Unis, 71106
- Pfizer Investigational Site
-
-
Maryland
-
Baltimore, Maryland, États-Unis, 21211
- Pfizer Investigational Site
-
Glen Burnie, Maryland, États-Unis, 21061
- Pfizer Investigational Site
-
Towson, Maryland, États-Unis, 21204
- Pfizer Investigational Site
-
-
Massachusetts
-
Springfield, Massachusetts, États-Unis, 01103
- Pfizer Investigational Site
-
-
Michigan
-
Grand Rapids, Michigan, États-Unis, 49503
- Pfizer Investigational Site
-
Kalamazoo, Michigan, États-Unis, 49009
- Pfizer Investigational Site
-
-
Minnesota
-
Edina, Minnesota, États-Unis, 55435
- Pfizer Investigational Site
-
-
Mississippi
-
Picayune, Mississippi, États-Unis, 39466
- Pfizer Investigational Site
-
Southaven, Mississippi, États-Unis, 38671
- Pfizer Investigational Site
-
-
Missouri
-
St. Louis, Missouri, États-Unis, 63117
- Pfizer Investigational Site
-
-
Nebraska
-
Lincoln, Nebraska, États-Unis, 68516
- Pfizer Investigational Site
-
Omaha, Nebraska, États-Unis, 68114
- Pfizer Investigational Site
-
-
Nevada
-
Las Vegas, Nevada, États-Unis, 89119
- Pfizer Investigational Site
-
-
New Jersey
-
Moorestown, New Jersey, États-Unis, 08057
- Pfizer Investigational Site
-
Sewell, New Jersey, États-Unis, 08080
- Pfizer Investigational Site
-
-
New York
-
Albany, New York, États-Unis, 12208
- Pfizer Investigational Site
-
Brooklyn, New York, États-Unis, 11215
- Pfizer Investigational Site
-
Staten Island, New York, États-Unis, 10304
- Pfizer Investigational Site
-
Williamsville, New York, États-Unis, 14221
- Pfizer Investigational Site
-
-
North Carolina
-
Cary, North Carolina, États-Unis, 27518
- Pfizer Investigational Site
-
Cary, North Carolina, États-Unis, 27511
- Pfizer Investigational Site
-
Raleigh, North Carolina, États-Unis, 27612
- Pfizer Investigational Site
-
-
Ohio
-
Willoughby Hills, Ohio, États-Unis, 44094
- Pfizer Investigational Site
-
-
Oklahoma
-
Bethany, Oklahoma, États-Unis, 73008
- Pfizer Investigational Site
-
Norman, Oklahoma, États-Unis, 73069
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, États-Unis, 73112
- Pfizer Investigational Site
-
Oklahoma City, Oklahoma, États-Unis, 73109
- Pfizer Investigational Site
-
-
Oregon
-
Portland, Oregon, États-Unis, 97205
- Pfizer Investigational Site
-
-
Pennsylvania
-
Altoona, Pennsylvania, États-Unis, 16602
- Pfizer Investigational Site
-
Erie, Pennsylvania, États-Unis, 16507
- Pfizer Investigational Site
-
Pittsburgh, Pennsylvania, États-Unis, 15243
- Pfizer Investigational Site
-
-
Rhode Island
-
East Providence, Rhode Island, États-Unis, 02914
- Pfizer Investigational Site
-
East Providence, Rhode Island, États-Unis, 02915
- Pfizer Investigational Site
-
-
South Carolina
-
Charleston, South Carolina, États-Unis, 29425
- Pfizer Investigational Site
-
Columbia, South Carolina, États-Unis, 29201
- Pfizer Investigational Site
-
Myrtle Beach, South Carolina, États-Unis, 29572
- Pfizer Investigational Site
-
-
Tennessee
-
Bristol, Tennessee, États-Unis, 37620
- Pfizer Investigational Site
-
Chattanooga, Tennessee, États-Unis, 37404
- Pfizer Investigational Site
-
Jackson, Tennessee, États-Unis, 38305
- Pfizer Investigational Site
-
Memphis, Tennessee, États-Unis, 38119
- Pfizer Investigational Site
-
-
Texas
-
Austin, Texas, États-Unis, 78745
- Pfizer Investigational Site
-
Austin, Texas, États-Unis, 78757
- Pfizer Investigational Site
-
Corpus Christi, Texas, États-Unis, 78414
- Pfizer Investigational Site
-
Houston, Texas, États-Unis, 77074
- Pfizer Investigational Site
-
Houston, Texas, États-Unis, 77062
- Pfizer Investigational Site
-
Leander, Texas, États-Unis, 78641
- Pfizer Investigational Site
-
Longview, Texas, États-Unis, 75605
- Pfizer Investigational Site
-
Longview, Texas, États-Unis, 75601
- Pfizer Investigational Site
-
San Antonio, Texas, États-Unis, 78229
- Pfizer Investigational Site
-
San Antonio, Texas, États-Unis, 78216
- Pfizer Investigational Site
-
Temple, Texas, États-Unis, 76508
- Pfizer Investigational Site
-
-
Utah
-
Murray, Utah, États-Unis, 84107
- Pfizer Investigational Site
-
Salt Lake City, Utah, États-Unis, 84103
- Pfizer Investigational Site
-
West Jordan, Utah, États-Unis, 84088
- Pfizer Investigational Site
-
-
Virginia
-
Richmond, Virginia, États-Unis, 23229
- Pfizer Investigational Site
-
-
Washington
-
Burien, Washington, États-Unis, 98166
- Pfizer Investigational Site
-
Spokane, Washington, États-Unis, 99216
- Pfizer Investigational Site
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
65 ans et plus (Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Quadruple
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Comparateur placebo: Placebo
|
Placebo sham 4 mg and 8 mg
|
|
Expérimental: Fésotérodine
|
Fesoterodine 4 mg and 8 mg
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Questionnaire sur la vessie hyperactive (OAB-q) Score de gêne des symptômes
Délai: Ligne de base
|
OAB-q : un questionnaire auto-administré de 33 items qui évalue dans quelle mesure le participant a été gêné par des symptômes vésicaux sélectionnés.
Chaque élément est noté par le participant sur l'échelle de Likert de 1 (le moins gênant par les symptômes) à 6 (le plus gênant par les symptômes).
Score de gêne des symptômes dérivé de la somme des scores pour les questions 1 à 8 ; score brut le plus bas possible : 8 ; score le plus élevé possible : 48.
Données analysées sur la base de la transformation du score sur une échelle de 0 à 100 [(Score brut total réel - valeur la plus basse possible du score brut)/plage]*100.
Des valeurs de scores plus élevées indiquent une plus grande gêne des symptômes.
|
Ligne de base
|
|
Domaine de qualité de vie liée à la santé (HRQL) et score total du questionnaire sur la vessie hyperactive (OAB-q)
Délai: Ligne de base
|
OAB-q : questionnaire auto-administré de 33 items, évalue dans quelle mesure le participant a été dérangé par des symptômes vésicaux sélectionnés.
Chaque élément est évalué sur l'échelle de Likert de 1 (le moins gênant par les symptômes) à 6 (le plus gênant par les symptômes).
Les questions 9 à 33 constituent la QVLS et comprennent les domaines : préoccupation, adaptation, sommeil et fonction sociale.
Le domaine HRQL et le score brut total sont dérivés de la somme des scores.
Plage de score transformée de 0 à 100 (QVLS totale ou domaine) = [(Score brut le plus élevé possible - Score brut total réel)/Plage de score brut]*100.
Des scores transformés plus élevés indiquent une meilleure QVLS.
|
Ligne de base
|
|
Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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)
Délai: 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
Délai: 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
Délai: Baseline, Week 4, 12
|
PVR volume is defined as volume of urine remaining in the bladder immediately after urination.
|
Baseline, Week 4, 12
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude
1 septembre 2009
Achèvement primaire (Réel)
1 septembre 2011
Achèvement de l'étude (Réel)
1 septembre 2011
Dates d'inscription aux études
Première soumission
24 juin 2009
Première soumission répondant aux critères de contrôle qualité
24 juin 2009
Première publication (Estimation)
25 juin 2009
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
17 janvier 2013
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 décembre 2012
Dernière vérification
1 décembre 2012
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies urologiques
- Maladies de la vessie urinaire
- Symptômes des voies urinaires inférieures
- Manifestations urologiques
- Vessie urinaire, hyperactive
- Effets physiologiques des médicaments
- Agents neurotransmetteurs
- Mécanismes moléculaires de l'action pharmacologique
- Antagonistes muscariniques
- Antagonistes cholinergiques
- Agents cholinergiques
- Agents urologiques
- Fésotérodine
Autres numéros d'identification d'étude
- A0221049
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .