Local, Open-Label, Extension Trial Of The Efficacy And Safety Of Fesoterodine In Elderly Patients With Overactive Bladder

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01054222
First received: January 20, 2010
Last updated: April 2, 2013
Last verified: February 2013
  Purpose

This is an open-label extension study intended for subjects who have previously completed study A0221045 (fesoterodine in elderly OAB patients) and who have been recommended by the investigator as being suitable for the extended use of Fesoterodine. Data from this study will extend the evaluation of efficacy, tolerability and safety of Fesoterodine in older subjects from Portugal.


Condition Intervention Phase
Urinary Bladder, Overactive
Drug: Fesoterodine
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Local, Multicentre, Open-Label, Extension Trial To Evaluate The Efficacy And Safety Of Fesoterodine Flexible Dose Regimen In Elderly Patients With Overactive Bladder

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Mean Number of Micturition-Related Urgency Episodes Per 24 Hours (End of Treatment [EOT]) [ Time Frame: End of Treatment (up to Week 82) ] [ 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 Urinary Sensation Scale (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.


Secondary Outcome Measures:
  • Mean Number of Micturition-Related Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18 ] [ 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.

  • Mean Number of Severe Micturition-Related Urgency Episodes Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ Designated as safety issue: No ]
    The mean number of severe micturition-related urgency episodes per 24 hours was calculated as the total number of micturitions with USS rating of greater than or equal to (>=) 4 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.

  • Mean Number of Micturitions Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ 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 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.

  • Mean Number of Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ 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.

  • Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ 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.

  • Daily Sum Rating on the Urinary Sensation Scale (USS) [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ Designated as safety issue: No ]
    The daily sum rating was calculated as the mean rating score on the USS multiplied by the mean number of micturitions per 24 hours 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. Numerical decrease indicates improvement.

  • Percentage of Incontinent Participants at Baseline [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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.

  • Percentage of Participants With No Urgency Urinary Incontinence (UUI) Episode [ Time Frame: Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ Designated as safety issue: No ]
    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.

  • Mean Number of Urinary Incontinence Pads, Barrier Creams and Powder Used Per 24 Hours [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ Designated as safety issue: No ]
    The mean number of urinary incontinence pads (IP), barrier creams (BC) and powder used per 24 hours is calculated as the total number of IP, BC and powder used divided by the total number of diary days collected at that visit.

  • Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Month 3,6,9,12,15,18, and End of Treatment [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ Designated as safety issue: No ]
    PPBC: self-administered, single-item, questionnaire that asked participants to describe their perception of their bladder-related problems. PPBC assessment 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. Change = observation minus baseline. Results categorized as Deterioration (score difference ≥1), No Change (score difference=0), Improvement (score difference less than [<]0).

  • Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Months 3,6,9,12,15,18, and End of Treatment [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ Designated as safety issue: No ]
    PPUS: self-administered, single-item, questionnaire that measured the participant's perception of urinary urgency. It was sensitive to changes in perceptions of urinary urgency over time. Score of 0 (usually not able to hold urine), 1 (usually able to hold urine [without leaking] until reaching toilet if go to toilet immediately), or 2 (usually able to finish what he/she was doing before going to toilet [without leaking]). Change = observation minus baseline. Deterioration: negative difference of scores; improvement: increase of 1 or more points in difference of scores, relative to baseline.

  • Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ 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, Month 3, 6, 9, 12, 15, 18, End of Treatment (Week 82) ] [ 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.

  • Number of Participants With Response to Overactive Bladder Satisfaction Questionnaire (OAB-s) (Questions 5, 9, 10a-10d, and 11a-11b) [ Time Frame: Baseline, Month 3, 6, 9, 12, 15, 18, End of Treatment (EOT) (Week 82) ] [ Designated as safety issue: No ]
    OAB-s assessed OAB medication expectations, daily life with OAB, and satisfaction with OAB medication. Question (Q) 5 evaluates OAB medication expectations (exceeds/meets or does not meet expectation). Q9 to 11 assessed satisfaction with OAB medication's ability to allow reaching bathroom without urine loss (Q9), decrease: sudden urgencies to urinate (Q10a), urine loss due to urgency (Q10b), waking up at night to urinate (Q10c) and urination during day (Q10d), and improve control of urine loss (Q11a) and need to urinate (Q11b). Q9 to 11 were answered as 'very satisfied', 'somewhat satisfied', 'neither dissatisfied nor satisfied', 'somewhat dissatisfied', and 'very dissatisfied'. The results for Q9 to 11 are reported as "satisfied" (participants who answered 'very satisfied' or 'somewhat satisfied' for all 7 questions) or "not satisfied" (participants who answered 'neither dissatisfied nor satisfied' or 'somewhat dissatisfied' or 'very dissatisfied' for all 7 questions).

  • King's Health Questionnaire (KHQ) Domain Scores [ Time Frame: Baseline, End of Treatment (EOT) (Week 82) ] [ Designated as safety issue: No ]
    KHQ: self-administered questionnaire contained 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, and severity of urinary symptoms). Each domain score ranged: 0-100, where 0=best outcome/response and 100=worst outcome/response.


Enrollment: 31
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Fesoterodine 4 mg
Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
Drug: Fesoterodine
Fesoterodine fumarate, sustained release (SR) tablet, 4 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)
Other Name: Toviaz
Fesoterodine 8 mg
Dose determined as per previous drug regime in A0221045 and investigator's evaluation.
Drug: Fesoterodine
Fesoterodine fumarate, sustained release (SR) tablet, 8 mg once daily, oral, duration - until fesoterodine is commercially available in Portugal or until 31 Dec 2011 (whichever is earlier)
Other Name: Toviaz

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must have previously completed fesoterodine study A0221045 [in Portugal]
  • Subjects must be recommended for inclusion by the investigator

Exclusion Criteria:

  • Conditions or states excluding use of fesoterodine e.g. contraindication to fesoterodine
  • Predominant stress incontinence as determined by the investigator
  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: NCT01054222

Locations
Portugal
Centro de Avaliação Geriátrica
Lisboa, Portugal, 1990-273
Hospital Ordem do Carmo
Porto, Portugal, 4099-005
Hospital de São João
Porto, Portugal, 4200-319
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: NCT01054222     History of Changes
Other Study ID Numbers: A0221090
Study First Received: January 20, 2010
Results First Received: December 17, 2012
Last Updated: April 2, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Pfizer:
overactive bladder idiopathic
elderly fesoterodine SOFIA Portugal extension study

Additional relevant MeSH terms:
Urinary Bladder, Overactive
Urinary Bladder Diseases
Urologic Diseases
Lower Urinary Tract Symptoms
Urological Manifestations
Signs and Symptoms
Fesoterodine
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Urological Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014