A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

Study Overview
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Brief Summary
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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.

Official Title
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A 12-Week, Multicenter, Open-Label, Single-Arm Study To Evaluate The Effects Of Fesoterodine On Treatment Satisfaction And Symptom Relief In Overactive Bladder Patients.

Conditions
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Overactive Bladder

Intervention / Treatment
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* Drug: fesoterodine fumarate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open Label-fesoterodine<br>Single treatment study arm. | Drug: fesoterodine fumarate<br>* 12 weeks of study treatment: Subjects received fesoterodine tablets 4 mg once daily for 4 weeks; thereafter, daily dosage was maintained at 4 mg or increased to 8 mg based on subject's and physician's subjective assessment of efficacy and tolerability.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Number of Micturition Episodes Per 24 Hours | 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. | Baseline and Week 12 | 
| Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours | 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. | Baseline and Week 12 | 
| Mean Number of Urgency Episodes Per 24 Hours | 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. | Baseline and Week 12 | 
| Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment | Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nocturnal Micturitions Per 24 Hours | Nocturnal micturitions (synonymous with the term nighttime micturitions) were those recorded in the bedtime section of the bladder diary. | Baseline and Week 12 | 
| Severe Urgency Episodes Per 24 Hours | 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. | Baseline and Week 12 | 
| Mean Rating on the Urinary Sensation Scale | 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. | Baseline and Week 12 | 
| Patient Perception of Bladder Condition (PPBC) Score | The PPBC score ranges from 1 no problems at all to 6 many severe problems. | Baseline and Week 12 | 
| Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) | Improvement: negative score change; No change: score change=0; Deterioration: positive score change | Baseline and Week 12 | 
| Urgency Perception Scale (UPS) | 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]). | Baseline and Week 12 | 
| Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) | Improvement: positive score change; No improvement: zero or negative score change | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain | 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. | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain | 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. | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain | 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. | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain | 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. | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale | 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. | Baseline and Week 12 | 
| Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale | 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. | Baseline and Week 12 | 
| Satisfaction With OAB Control Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) | 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. | Week 12 | 
| Sum Rating on the Urinary Sensation Scale | 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. | Baseline and Week 12 | 
| Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) | 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. | Week 12 |