A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
- Registration Number
- NCT00425100
- Lead Sponsor
- Pfizer
- Brief Summary
To evaluate the effect of fesoterodine on patient satisfaction and overactive bladder (OAB) symptom relief in OAB patients who were dissatisfied with their prior therapy with tolterodine.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 516
- OAB patients who present with OAB symptoms(≥8 micturitions and ≥3 urgency episodes per 24 h documented in the baseline bladder diary)
- OAB patients dissatisfied with their prior therapy with tolterodine
- Patients with any contraindication to fesoterodine usage, e.g., urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, or known hypersensitivity to the drug or its ingredients.
- Patients with significant hepatic and renal disease or other significant unstable diseases.
- OAB symptoms caused by neurological conditions, known pathologies of urinary tract, etc.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Open Label-fesoterodine fesoterodine fumarate Single treatment study arm.
- Primary Outcome Measures
Name Time Method Mean Number of Micturition Episodes Per 24 Hours Baseline and Week 12 The mean number of micturitions per 24 hours is calculated as the total number of micturitions divided by the total number of diary days collected at that visit.
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours Baseline and Week 12 The mean number of UUI episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) = 5 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Mean Number of Urgency Episodes Per 24 Hours Baseline and Week 12 The mean number of urgency episodes per 24 hours is calculated as the total number of micturitions with Bladder Sensation Scale (BSS) \>= 3 divided by the total number of diary days collected at that visit. BSS: 5 point scale measuring need to urinate from 1=no urgency to 5=unable to hold; leak urine.
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment Week 12 Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
- Secondary Outcome Measures
Name Time Method Severe Urgency Episodes Per 24 Hours Baseline and Week 12 Severe urgency episodes defined as Urinary Sensation Scale (USS) rating ≥4. Subjects rated the feeling of urgency associated with each micturition episode using USS provided in the bladder diary. Scale ranges from 1=no feeling of urgency to 5=unable to hold; leak urine; decrease indicates an improvement with respect to urgency symptoms.
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) Baseline and Week 12 Improvement: negative score change; No change: score change=0; Deterioration: positive score change
Urgency Perception Scale (UPS) Baseline and Week 12 UPS scores range from 0 ("I am usually not able to hold urine") to 2 ("I am usually able to finish what I am doing before going to the toilet \[without leaking\]").
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) Baseline and Week 12 Improvement: positive score change; No improvement: zero or negative score change
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain Baseline and Week 12 Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale Baseline and Week 12 Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale Baseline and Week 12 Each item rated by subject on a Likert scale 1 (least symptom bother) to 6 (most symptom bother). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent less favorable outcome.
Patient Perception of Bladder Condition (PPBC) Score Baseline and Week 12 The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."
Nocturnal Micturitions Per 24 Hours Baseline and Week 12 Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.
Mean Rating on the Urinary Sensation Scale Baseline and Week 12 The mean rating was calculated as the sum of rating scores on the Urinary Sensation Scale divided by the total number of micturitions with non-missing rating at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain Baseline and Week 12 Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain Baseline and Week 12 Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain Baseline and Week 12 Each item rated by subject on a Likert scale 1 (most favorable) to 6 (least favorable). Raw scores were transformed to a score from 0 to 100. Once transformed, higher scores represent more favorable outcome.
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) Week 12 Module coded on scale (1-very satisfied to 5-very dissatisfied). Coding reversed algorithmically \& results transformed: total score range 0-100. Higher final response value associated with better satisfaction. Satisfied on TSQ = very or somewhat satisfied; Not satisfied on TSQ =very or somewhat dissatisfied or neither dissatisfied nor satisfied.
Sum Rating on the Urinary Sensation Scale Baseline and Week 12 The sum rating per 24 hours was calculated as the mean rating score on the Urinary Sensation Scale multiplied by the mean number of micturitions per 24 hours at that visit. The scale ranges from 1 "no feeling of urgency" to 5 "unable to hold; leak urine."
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) Week 12 Number of participants who responded satisfied = (very satisfied or somewhat satisfied) or dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question at Week 12 in the safety set.
Trial Locations
- Locations (1)
Pfizer Investigational Site
🇺🇦Zaporizhzhia, Ukraine