UK Study Assessing Flexible Dose Fesoterodine in Adults (SAFINA)

This study has been completed.
Sponsor:
Information provided by:
Pfizer
ClinicalTrials.gov Identifier:
NCT00806494
First received: December 9, 2008
Last updated: January 4, 2011
Last verified: January 2011
  Purpose

To explore the effects of fesoterodine when used in a flexible dose manner


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A 12 Week, Multi-centre, Open Label Study To Evaluate The Efficacy, Tolerability And Safety Of A Fesoterodine Flexible Dose Regimen In Patients With Overactive Bladder.

Resource links provided by NLM:


Further study details as provided by Pfizer:

Primary Outcome Measures:
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, more specifically (ie), a decrease in number of micturitions relative to baseline=improvement.


Secondary Outcome Measures:
  • Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 [ Time Frame: Baseline, Week 4 ] [ Designated as safety issue: No ]
    The number of micturitions was measured by the 3-day bladder diary completed for the 3 consecutive days preceding each clinic visit. The mean number of micturitions per 24 hours was calculated as the sum of all micturitions recorded in the diary divided by the number of days the diary was completed at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of micturitions relative to baseline=improvement.

  • Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Percentage change from baseline in micturitions was calculated as change in mean number of micturitions per 24 hours at that visit divided by the baseline mean number of micturitions per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Nocturnal micturitions were defined as those occurring between the time the subject went to bed and the time he or she arose to start the next day. 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=mean at observation minus mean at baseline. Negative change, ie, decrease in number of nocturnal micturitions relative to baseline=improvement.

  • Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Percentage change from baseline in nocturnal micturitions was calculated as change in mean number of nocturnal micturitions per 24 hours at that visit divided by the baseline mean number of nocturnal micturitions per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]

    UUI episodes were defined as those with a Urinary Sensation Scale (USS) rating of 5 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Mean number of UUI episodes per 24 hours was calculated as total number of micturitions with USS rating of 5 divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of UUI episodes relative to baseline=improvement.


  • Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Percentage change from baseline in UUI episodes was calculated as change in mean number of UUI episodes per 24 hours at that visit divided by the baseline mean number of episodes per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Urgency episodes were defined as those with a USS rating of >=3 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of urgency episodes per 24 hours was calculated as total number of urgency episodes divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of urgency episodes relative to baseline=improvement.

  • Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Percentage change from baseline in urgency episodes was calculated as change in mean number of urgency episodes per 24 hours at that visit divided by the baseline mean number of urgency episodes per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Nocturnal Urgency Episodes (NUEs) Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]

    NUEs were defined as those with a USS rating of >=3 in the diary, occurring between the time the participant goes to bed and the time he/she arises to start the next day. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine).

    Mean number of NUEs per 24 hours was calculated as total number of NUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of NUEs relative to baseline=improvement.


  • Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Percentage change from baseline in NUEs was calculated as change in mean number of NUEs per 24 hours at that visit divided by the baseline mean number of NUEs per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Severe Urgency Episodes (SUEs) Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    SUEs were defined as those with a USS rating of >=4 in the diary. USS: 5-item scale to measure urinary urgency; range: 1 (no feeling of urgency) to 5 (unable to hold; leak urine). Mean number of SUEs per 24 hours was calculated as total number of SUEs divided by total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of SUEs relative to baseline=improvement.

  • Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    Percentage change from baseline in SUEs was calculated as the change in mean number of SUEs per 24 hours at that visit divided by the baseline mean number of SUEs per 24 hours, multiplied by 100.

  • Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    The mean number of incontinence pads used per 24 hours was calculated as the total number of incontinence pads used divided by the total number of diary days collected at that visit. Change=mean at observation minus mean at baseline. Negative change, ie, decrease in number of incontinence pads used relative to baseline=improvement.

  • Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    PPBC: self-administered, single-item, questionnaire to describe perception of participants bladder-related problems (rated on 6-point scale: 1=no problems at all, 2=some very minor, 3=some minor, 4=some moderate, 5=severe, 6=many severe problems). Score change=score at observation minus score at baseline; re-scaled to 4-point categorical variables (major improvement [score difference <=-2]; minor improvement [score difference =-1]; no change [score difference = 0]; deterioration [score difference >=1]), based on PPBC score.

  • Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    UPS: self-administered, single-item questionnaire to measure participant's perception of urinary urgency (rated on 3-point scale: 1=usually not able to hold urine; 3=usually able to finish what I am doing before going to toilet without leaking). Score change=score at observation minus score at baseline; re-scaled to 3-point categorical variables (improvement [Increase of 1 or more points in difference of scores]; no change [score difference=0]; deterioration [Negative difference of scores], based on UPS score, with number of participants in each of the 3-point categories.

  • Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12 [ Time Frame: Baseline, Week 4 and Week 12 ] [ Designated as safety issue: No ]
    OAB-q symptom bother scale (8 items) is part of the OAB-q. Symptom bother score=sum of scores for items 1 to 8 (each symptom bother item measured on 6-point Likert scale ranging from 1 (not at all) to 6 (a very great deal). Lowest possible raw score=8; highest possible score=48. Data analyzed based on transformation of score to a 0 to 100 scale: (Actual total raw score - lowest possible value of raw score)/raw score range * 100. 0=no symptom bother, 100=high symptom bother. Change=mean score at observation minus mean score at baseline, negative change in score=improvement.

  • Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    ICIQ-SF: self-administered questionnaire for assessment and quantification of incontinence and its impact on quality of life. ICIQ score=sum of the responses to 3 questions: How often do you leak urine? (range: 0=never to 5=all the time); How much urine do you usually leak? (range: 0=none to 6=a large amount); Overall, how much does leaking urine interfere with your everyday life? (range: 0=not at all to 10=a great deal). Score range=0 (low bother from urine leakage) to 21 (maximum bother). Negative change (decrease) from baseline in score value=reduced level of bother.

  • Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire [ Time Frame: Week 12 (or Early Withdrawal) ] [ Designated as safety issue: No ]
    BSW: 3-item questionnaire to assess participants perception of effect of treatment in terms of treatment benefit, satisfaction with treatment, and participants willingness to continue treatment. Response to each item recorded in dichotomous fashion (Benefit: yes/no, yes - little benefit/much benefit; Satisfaction: yes/no, yes - a little satisfied/very satisfied, no - a little dissatisfied/very dissatisfied; Willingness to continue: yes/no, yes - a little bit willing/very willing, no - a little unwilling/very unwilling).

  • Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12 [ Time Frame: Week 12 (or Early Withdrawal) ] [ Designated as safety issue: No ]
    TSQ: Independent component of the overactive bladder TSQ. Self- administered, 1-item measure of participant satisfaction for participants receiving treatment for OAB. The 5 categorical responses were grouped to 'Satisfied' (including 'very satisfied' and 'somewhat satisfied') and 'Dissatisfied' (including 'very dissatisfied','somewhat dissatisfied', and 'neither dissatisfied nor satisfied'). Percentage of participants reporting satisfaction included those with categorical responses of 'very satisfied' and 'somewhat satisfied'.

  • Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
    KHQ: Self-administered questionnaire containing 21 questions scored in 9 domains (general health perception, incontinence impact, role limitations, physical limitations, social limitations, personal relationships, emotions, sleep/energy, severity of urinary symptoms). Each domain was a categorical scale that was converted to a numeric score. All domains transformed to a range of 0 to 100, where 0=best outcome/response and 100=worst outcome/response. Change=mean score at Week 12 minus mean score at baseline, negative change from baseline=improvement.


Enrollment: 331
Study Start Date: February 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Arm
Fesoterodine 4mg, escalating to 8mg as required
Drug: Fesoterodine
Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated

  Eligibility

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

Inclusion Criteria:

  • Male or female >18 years old
  • OAB for >3 months

Exclusion Criteria:

  • Patients with conditions that would contraindicate for fesoterodine use
  • Patients with significant hepatic and renal disease or other significant unstable diseases.
  • OAB symptoms caused by neurological conditions, known pathologies of urinary tract, 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: NCT00806494

Locations
United Kingdom
Pfizer Investigational Site
Ely, Cambridgeshire, United Kingdom, CB7 5JD
Pfizer Investigational Site
Crewe, Cheshire, United Kingdom, CW1 4QJ
Pfizer Investigational Site
Fowey, Cornwall, United Kingdom, PL23 1DT
Pfizer Investigational Site
Penzance, Cornwall, United Kingdom, TR18 4JH
Pfizer Investigational Site
Chesterfield, Derbyshire, United Kingdom, S44 5BL
Pfizer Investigational Site
Chesterfield, Derbyshire, United Kingdom, S40 4TF
Pfizer Investigational Site
Plymouth, Devon, United Kingdom, PL5 3JB
Pfizer Investigational Site
Bexhill on Sea, East Sussex, United Kingdom, TN40 1JJ
Pfizer Investigational Site
Baillieston, Glasgow, United Kingdom, G69 7AD
Pfizer Investigational Site
Blackpool, Lancashire, United Kingdom, FY4 3AD
Pfizer Investigational Site
Blackpool, Lancashire, United Kingdom, FY3 7EN
Pfizer Investigational Site
Hinckley, Leicestershire, United Kingdom, LE10 2SE
Pfizer Investigational Site
West Didsbury, Manchester, United Kingdom, M20 2LR
Pfizer Investigational Site
Ashford, Middlesex, United Kingdom, TW15 3EA
Pfizer Investigational Site
Northwood, Middlesex, United Kingdom, HA6 2RN
Pfizer Investigational Site
Mortimer, Reading, United Kingdom, RG7 2BH
Pfizer Investigational Site
Ayrshire, Scotland, United Kingdom, KA12 0AY
Pfizer Investigational Site
Falkirk, Scotland, United Kingdom, FK1 5QE
Pfizer Investigational Site
Winterton, Scunthorpe, United Kingdom, DN15 9TA
Pfizer Investigational Site
Bath, Somerset, United Kingdom, BA1 2SR
Pfizer Investigational Site
Doncaster, South Yorkshire, United Kingdom, DN9 1ND
Pfizer Investigational Site
Sheffield, South Yorkshire, United Kingdom, S7 2DW
Pfizer Investigational Site
Addlestone, Surrey, United Kingdom, KT15 2BH
Pfizer Investigational Site
Leatherhead, Surrey, United Kingdom, KT24 6QT
Pfizer Investigational Site
Worthing, West Sussex, United Kingdom, BN11 2DH
Pfizer Investigational Site
Bradford-on-Avon, Wiltshire, United Kingdom, BA1 5DQ
Pfizer Investigational Site
Chippenham, Wilts, United Kingdom, SN14 8GT
Pfizer Investigational Site
Bath, United Kingdom, BA2 3HT
Pfizer Investigational Site
Bath, United Kingdom, BA2 4BY
Pfizer Investigational Site
Bristol, United Kingdom, BS2 8HW
Pfizer Investigational Site
Bucks, United Kingdom, HP22 5LB
Pfizer Investigational Site
Glasgow, United Kingdom, G51 4TF
Pfizer Investigational Site
Hertfordshire, United Kingdom, WD25 0EA
Pfizer Investigational Site
London, United Kingdom, W1P 9LL
Pfizer Investigational Site
London, United Kingdom, SE5 9RS
Pfizer Investigational Site
Northants, United Kingdom, NN8 4RW
Pfizer Investigational Site
Plymouth, United Kingdom, PL6 8DH
Pfizer Investigational Site
Swansea, United Kingdom, SA6 6NL
Pfizer Investigational Site
Swindon, United Kingdom, SN25 4YZ
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
  More Information

Additional Information:
No publications provided

Responsible Party: Director, Clinical Trial Disclosure Group, Pfizer, Inc.
ClinicalTrials.gov Identifier: NCT00806494     History of Changes
Other Study ID Numbers: A0221058
Study First Received: December 9, 2008
Results First Received: January 4, 2011
Last Updated: January 4, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by Pfizer:
Fesoterodine
Open Label
Flexible Dose
OAB

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

ClinicalTrials.gov processed this record on July 20, 2014