Overactive BladderPhase 4NCT00911937
A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency
A Phase 4 study testing Fesoterodine in people with Overactive Bladder, run by Pfizer at 112 sites in United States.
Trial summary
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overactive Bladder
- What is being tested?
- Fesoterodine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 963 participants
- Where
- 112 sitesUnited States
- Study dates
- Aug 2009to Sep 2011
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
- Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
- Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)
Who cannot join
- A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
- Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Trial locations and contacts
112 sites in 1 country.
112 sites in 1 country
United States112 sites
Pfizer Investigational Site
Akron, Ohio, 44311
Pfizer Investigational Site
Anderson, South Carolina, 29621
Pfizer Investigational Site
Annapolis, Maryland, 21401
Pfizer Investigational Site
Atlanta, Georgia, 30329-5102
Pfizer Investigational Site
Bala-Cynwyd, Pennsylvania, 19004
Pfizer Investigational Site
Bonita Springs, Florida, 34134
Pfizer Investigational Site
Bridgeville, Pennsylvania, 15017
Pfizer Investigational Site
Bristol, Tennessee, 37620
Pfizer Investigational Site
Brooklyn, New York, 11215
Pfizer Investigational Site
Brooksville, Florida, 34601
Pfizer Investigational Site
Bryan, Texas, 77802
Pfizer Investigational Site
Burlington, North Carolina, 27215
Pfizer Investigational Site
Cary, North Carolina, 27518
Pfizer Investigational Site
Charlotte, North Carolina, 28207
Pfizer Investigational Site
Chaska, Minnesota, 55318
Pfizer Investigational Site
Chicago, Illinois, 60634
Pfizer Investigational Site
Chicago, Illinois, 60654
Pfizer Investigational Site
Cincinnati, Ohio, 45249
Pfizer Investigational Site
Coeur d'Alene, Idaho, 83814
Pfizer Investigational Site
Columbus, Ohio, 43214
Pfizer Investigational Site
Columbus, Ohio, 43221
Pfizer Investigational Site
Concord, North Carolina, 28025
Pfizer Investigational Site
Dallas, Texas, 75231
Pfizer Investigational Site
Dayton, Ohio, 45439
Pfizer Investigational Site
DeFuniak Springs, Florida, 32435
Pfizer Investigational Site
Denver, Colorado, 80218
Pfizer Investigational Site
Denver, Colorado, 80220
Pfizer Investigational Site
Destin, Florida, 32541
Pfizer Investigational Site
Dover, Delaware, 19904
Pfizer Investigational Site
East Greenwich, Rhode Island, 02818
Pfizer Investigational Site
Fall River, Massachusetts, 02720
Pfizer Investigational Site
Fargo, North Dakota, 58103
Pfizer Investigational Site
Farmington, Connecticut, 06032
Pfizer Investigational Site
Fort Wayne, Indiana, 46825
Pfizer Investigational Site
Fresno, California, 93720
Pfizer Investigational Site
Garden City, New York, 11530
Pfizer Investigational Site
Goodyear, Arizona, 85395
Pfizer Investigational Site
Hamilton, New Jersey, 08690
Pfizer Investigational Site
Houston, Texas, 77024
Pfizer Investigational Site
Houston, Texas, 77030
Pfizer Investigational Site
Houston, Texas, 77079
Pfizer Investigational Site
Huntersville, North Carolina, 28078
Pfizer Investigational Site
Hyannis, Massachusetts, 02601
Pfizer Investigational Site
Iowa City, Iowa, 52242
Pfizer Investigational Site
Jeffersonville, Indiana, 47130
Pfizer Investigational Site
Kingsport, Tennessee, 37660
Pfizer Investigational Site
Kingston, New York, 12401
Pfizer Investigational Site
Knoxville, Tennessee, 37920
Pfizer Investigational Site
La Mesa, California, 91942
Pfizer Investigational Site
Lansdale, Pennsylvania, 19446
Pfizer Investigational Site
Leesburg, Florida, 34748
Pfizer Investigational Site
Lincoln, Nebraska, 68510
Pfizer Investigational Site
Litchfield Park, Arizona, 85340
Pfizer Investigational Site
Little Rock, Arkansas, 72205
Pfizer Investigational Site
Madisonville, Kentucky, 42431
Pfizer Investigational Site
Manlius, New York, 13104
Pfizer Investigational Site
Menomonee Falls, Wisconsin, 53051
Pfizer Investigational Site
Milan, Tennessee, 38358
Pfizer Investigational Site
Milford, Massachusetts, 01757
Pfizer Investigational Site
Mobile, Alabama, 36608
Pfizer Investigational Site
Mount Sterling, Kentucky, 40353
Pfizer Investigational Site
Mountlake Terrace, Washington, 98043
Pfizer Investigational Site
Mt. Pleasant, South Carolina, 29464
Pfizer Investigational Site
Naples, Florida, 34102
Pfizer Investigational Site
Nashville, Tennessee, 37203
Pfizer Investigational Site
New Bedford, Massachusetts, 02740
Pfizer Investigational Site
New Britain, Connecticut, 06052
Pfizer Investigational Site
New Tazewell, Tennessee, 37825
Pfizer Investigational Site
New York, New York, 10016
Pfizer Investigational Site
Newport Beach, California, 92660
Pfizer Investigational Site
Newton, Kansas, 67114
Pfizer Investigational Site
Norfolk, Virginia, 23502
Pfizer Investigational Site
Norwalk, Connecticut, 06850
Pfizer Investigational Site
Ocala, Florida, 34471
Pfizer Investigational Site
Ocala, Florida, 34474
Pfizer Investigational Site
Olive Branch, Mississippi, 38654
Pfizer Investigational Site
Omaha, Nebraska, 68114
Pfizer Investigational Site
Overland Park, Kansas, 66202
Pfizer Investigational Site
Overland Park, Kansas, 66210
Pfizer Investigational Site
Overland Park, Kansas, 66211
Pfizer Investigational Site
Pawtucket, Rhode Island, 02860
Pfizer Investigational Site
Pembroke Pines, Florida, 33024
Pfizer Investigational Site
Philadelphia, Pennsylvania, 19114
Pfizer Investigational Site
Phoenix, Arizona, 85020
Pfizer Investigational Site
Pittsburgh, Pennsylvania, 15236
Pfizer Investigational Site
Plano, Texas, 75024
Pfizer Investigational Site
Portland, Oregon, 97225
Pfizer Investigational Site
Poughkeepsie, New York, 12601
Pfizer Investigational Site
Pratt, Kansas, 67124
Pfizer Investigational Site
Richmond, Virginia, 23294
Pfizer Investigational Site
Roseville, California, 95661
Pfizer Investigational Site
Sacramento, California, 95825
Pfizer Investigational Site
Salisbury, North Carolina, 28144
Pfizer Investigational Site
San Diego, California, 92103-6204
Pfizer Investigational Site
San Diego, California, 92103
Pfizer Investigational Site
San Diego, California, 92108
Pfizer Investigational Site
Seattle, Washington, 98104
Pfizer Investigational Site
Sellersville, Pennsylvania, 18960
Pfizer Investigational Site
Shreveport, Louisiana, 71106
Pfizer Investigational Site
South Miami, Florida, 33143
Pfizer Investigational Site
Spokane, Washington, 99207
Pfizer Investigational Site
St Louis, Missouri, 63110
Pfizer Investigational Site
St. Petersburg, Florida, 33709
Pfizer Investigational Site
Tallahassee, Florida, 32308
Pfizer Investigational Site
Tampa, Florida, 33606
Pfizer Investigational Site
Tarzana, California, 91356
Pfizer Investigational Site
Troy, Michigan, 48098
Pfizer Investigational Site
Tucson, Arizona, 85741
Pfizer Investigational Site
Warwick, Rhode Island, 02886
Pfizer Investigational Site
Watertown, Massachusetts, 02472
Pfizer Investigational Site
West Des Moines, Iowa, 50266
Pfizer Investigational Site
Westerville, Ohio, 43081
About this study
Official title: A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.
- Conditions
- Overactive Bladder
- Being tested
- Fesoterodine, Placebo
- Keywords
- incontinence OAB urgency nocturia
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FesoterodineDrug
Fesoterodine 4mg and 8 mg tablets taken daily.
PlaceboDrug
Placebo sham 4mg and 8 mg tables taken daily.
| Study group | Role | What they receive |
|---|---|---|
| Fesoterodine | Experimental | Not described Receives: Drug: Fesoterodine |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours
Micturition-related nocturnal urgency episodes had urinary sensation scale (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.
Measured: Baseline
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
Micturition-related nocturnal 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.
Measured: Baseline and Week 12
Secondary outcomes (26)
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4
Micturition-related nocturnal 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 micturition-related nocturnal 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.
Measured: Baseline and Week 4
Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12
Percent change of micturition-related nocturnal 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 (100*(Week 4 or 12 - baseline)/baseline).
Measured: Baseline, Week 4 and 12
Number of Nocturnal Micturitions Per 24 Hours
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 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. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Measured: Baseline
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Nocturnal micturitions were defined as micturitions with USS rating 1-5 that occurred between the time the participant went to bed and the time he or she arose to start the next day. USS rating: 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. The mean number of nocturnal micturitions per 24 hours was calculated as the total number of nocturnal micturitions divided by the total number of diary days collected at that visit.
Measured: Baseline, Week 4 and 12
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Percent change of nocturnal 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 (100*(Week 4 or 12 - baseline)/baseline).
Measured: Baseline, Week 4 and 12
Mean Number of Micturitions Per 24 Hours
Micturitions include episodes of voluntary micturition and episodes of Urgency Urinary Incontinence [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.
Measured: Baseline
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 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.
Measured: Baseline, Week 4 and 12
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 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 (100*(Week 4 or 12 - baseline)/baseline).
Measured: Baseline, Week 4 and 12
Number of Micturition-related Urgency Episodes Per 24 Hours
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.
Measured: Baseline
Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 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.
Measured: Baseline, Week 4 and 12
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 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 (100*(Week 4 or 12 - baseline)/baseline).
Measured: Baseline, Week 4 and 12
Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
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.
Measured: Baseline
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 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.
Measured: Baseline, Week 4 and 12
Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 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 (100*(Week 4 or 12 - baseline)/baseline).
Measured: Baseline, Week 4 and 12
Nocturnal Frequency-urgency Sum Rating Per 24 Hours
Frequency-urgency sum is total USS ratings recorded for all nocturnal 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.
Measured: Baseline
Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Frequency-urgency sum is total USS ratings recorded for all nocturnal 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.
Measured: Baseline, Week 4 and 12
Frequency-urgency Sum Rating Per 24 Hours
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.
Measured: Baseline
Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 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.
Measured: Baseline, Week 4 and 12
Mean Voided Volume Per Nocturnal Micturition
Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Measured: Baseline
Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12
Mean voided volume per nocturnal micturition was calculated as sum of voided volume during bedtime divided by the total number of bedtime micturition episodes with a recorded voided volume greater than 0 at that visit.
Measured: Baseline and Week 12
Mean Voided Volume Per Micturition
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Measured: Baseline
Change From Baseline in Mean Voided Volume Per Micturition at Week 12
Mean voided volume per micturition was calculated as sum of voided volume divided by the total number of total micturition episodes with a recorded voided volume greater than 0 at that visit.
Measured: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
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.
Measured: Baseline
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 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.
Measured: Baseline, Week 4 and 12
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
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.
Measured: Baseline
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
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.
Measured: Baseline, Week 4 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Overactive BladderStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 963 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00911937
- Sponsor's protocol ID
- A0221048
- Status last verified
- Nov 2018
- First submitted
- 1 Jun 2009
- Last updated
- 4 Dec 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 37160401
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double Blind, Placebo Controlled, Parallel Group, Multicenter Trial To Evaluate The Efficacy And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency.
- ClinicalTrials.gov ID
- NCT00911937
- Acronym / sponsor ID
- A0221048
- Conditions
- Overactive Bladder
- Keywords
- incontinence OAB urgency nocturia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 963 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 3 Jun 2009 (estimated)
- Results
- Posted 14 Aug 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fesoterodine | Experimental | Drug: Fesoterodine |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Mean urinary frequency of >=8 micturitions per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in visit (Visit 2)
- Mean number of micturition related urgency episodes >=3 per 24 hours as verified by the screening bladder diary prior to Start of Placebo run in /Visit 2 (Urgency episodes are defined as those with Urinary Sensation Scale rating >=3)
- Mean number of micturition related nocturnal urgency episodes >=2 but no more than 8 episodes per 24 hours as verified by the bladder diary at Visit 2 (nocturnal urgency episodes are defined as those with Urinary Sensation Scale rating of >3 recorded in the bed time section of the bladder diary)
Key exclusion criteria (2 listed)
- A known recent history or previous diagnosis of any sleep disorder such as obstructive sleep apnea, primary insomnia, periodic limb movement, parasomnia
- Nocturia due to other underlying uncontrolled conditions, such as congestive heart failure, diabetes mellitus, diabetes insipidus, polyuria of any cause, etc.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FesoterodineFesoterodine 4mg and 8 mg tablets taken daily. | Drug | Fesoterodine |
| PlaceboPlacebo sham 4mg and 8 mg tables taken daily. | Drug | Placebo |
Primary outcome
Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours
Time frame: Baseline
Micturition-related nocturnal urgency episodes had urinary sensation scale (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.
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 12
Time frame: Baseline and Week 12
Micturition-related nocturnal 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.
26 secondary outcomes
Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4
Time frame: Baseline and Week 4
Percent Change From Baseline in Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Number of Nocturnal Micturitions Per 24 Hours
Time frame: Baseline
Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Mean Number of Micturitions Per 24 Hours
Time frame: Baseline
Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Number of Micturition-related Urgency Episodes Per 24 Hours
Time frame: Baseline
Change From Baseline in Number of Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Time frame: Baseline
Change From Baseline in Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Percent Change From Baseline in of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Nocturnal Frequency-urgency Sum Rating Per 24 Hours
Time frame: Baseline
Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Frequency-urgency Sum Rating Per 24 Hours
Time frame: Baseline
Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Mean Voided Volume Per Nocturnal Micturition
Time frame: Baseline
Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12
Time frame: Baseline and Week 12
Mean Voided Volume Per Micturition
Time frame: Baseline
Change From Baseline in Mean Voided Volume Per Micturition at Week 12
Time frame: Baseline and Week 12
Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score
Time frame: Baseline
Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12
Time frame: Baseline, Week 4 and 12
Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q)
Time frame: Baseline
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
Time frame: Baseline, Week 4 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37160401Stoniute 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.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
112 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fesoterodine in people with Overactive Bladder, run by Pfizer at 112 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 112 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Aug 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00911937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2018.