A Trial To Evaluate The Efficacy And Safety Of Fesoterodine In Patients With Symptoms Of Overactive Bladder Including Nocturnal Urinary Urgency

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT00911937
First received: June 1, 2009
Last updated: July 9, 2012
Last verified: July 2012
  Purpose

This study is designed to assess the efficacy of a flexible dose regimen of fesoterodine on micturition related nocturnal urgency episodes.


Condition Intervention Phase
Overactive Bladder
Drug: Fesoterodine
Drug: Placebo
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change From Baseline in Mean Number of Micturition-related Nocturnal Urgency Episodes Per 24 Hours at Week 4 [ Time Frame: Baseline and Week 4 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Number of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Number of Nocturnal Micturitions Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Nocturnal Micturitions Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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).

  • Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Micturitions Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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).

  • Number of Micturition-related Urgency Episodes Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • Percent Change From Baseline in Micturition-related Urgency Episodes Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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).

  • Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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).

  • Nocturnal Frequency-urgency Sum Rating Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Nocturnal Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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.

  • Frequency-urgency Sum Rating Per 24 Hours [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Frequency-urgency Sum Rating Per 24 Hours at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Voided Volume Per Nocturnal Micturition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean Voided Volume Per Nocturnal Micturition at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Mean Voided Volume Per Micturition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Mean Voided Volume Per Micturition at Week 12 [ Time Frame: Baseline and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Week 4 and 12 [ Time Frame: Baseline, Week 4 and 12 ] [ Designated as safety issue: No ]
    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.

  • Health Related Quality of Life (HRQL) Domain and Total Score of Overactive Bladder Questionnaire (OAB-q) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • 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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 963
Study Start Date: August 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Fesoterodine Drug: Fesoterodine
Fesoterodine 4mg and 8 mg tablets taken daily.
Placebo Comparator: Placebo Drug: Placebo
Placebo sham 4mg and 8 mg tables taken daily.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00911937

  Show 112 Study Locations
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00911937     History of Changes
Other Study ID Numbers: A0221048
Study First Received: June 1, 2009
Results First Received: July 9, 2012
Last Updated: July 9, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
incontinence OAB urgency nocturia

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Urological Manifestations
Signs and Symptoms

ClinicalTrials.gov processed this record on July 22, 2014