UK Study Assessing Flexible Dose Fesoterodine in Adults

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00806494
• Date of registration: 09/12/2008
• Prospective Registration: Yes
• Primary sponsor: Pfizer
• Public title: UK Study Assessing Flexible Dose Fesoterodine in Adults SAFINA
• Scientific 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.
• Date of first enrolment: February 2009
• Target sample size: 331
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00806494
• Study type: Interventional
• Phase: Phase 4

Countries of recruitment

United Kingdom

Contacts

• Name: Pfizer CT.gov Call Center
• Affiliation: Pfizer

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Urinary Bladder, Overactive

Intervention(s)

Drug: Fesoterodine

Primary Outcome(s)

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 [Time Frame: Baseline, Week 12]

Secondary Outcome(s)

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]

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]

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]

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]

Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

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]

Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12 [Time Frame: Baseline, Week 12]

Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12 [Time Frame: Week 12 (or Early Withdrawal)]

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)]

Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

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]

Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 [Time Frame: Baseline, Week 12]

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]

Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 [Time Frame: Baseline, Week 4 and Week 12]

Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 [Time Frame: Baseline, Week 4]

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]

Secondary ID(s)

A0221058

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 26/01/2011
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00806494