UK Study Assessing Flexible Dose Fesoterodine in Adults

Study Overview
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Brief Summary
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To explore the effects of fesoterodine when used in a flexible dose manner

Official Title
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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.

Conditions
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Urinary Bladder, Overactive

Intervention / Treatment
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* Drug: Fesoterodine


Participation Criteria
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Eligibility Criteria
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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.

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: Treatment Arm<br>Fesoterodine 4mg, escalating to 8mg as required | Drug: Fesoterodine<br>* Fesoterodine 4mg for 4 weeks, escalating to fesoterodine 8mg if tolerated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 12 | 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. | Baseline, Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Number of Micturitions Per 24 Hours at Week 4 | 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. | Baseline, Week 4 | 
| Percentage Change From Baseline in the Number of Micturitions Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Mean Number of Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Percentage Change From Baseline in Nocturnal Micturitions Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Percentage Change From Baseline in UUI Episodes Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Mean Number of Urgency Episodes Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Percentage Change From Baseline in Urgency Episodes Per 24 Hours at Weeks 4 and 12 | 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. | 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 | 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. | Baseline, Week 4 and Week 12 | 
| Percentage Change From Baseline in NUEs Per 24 Hours at Weeks 4 and 12 | 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. | 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 | 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. | Baseline, Week 4 and Week 12 | 
| Percentage Change From Baseline in SUEs Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Mean Number of Incontinence Pads Used Per 24 Hours at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Urgency Perception Scale (UPS) at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in Overactive Bladder Questionnaire (OAB-q) Symptom Bother Score at Weeks 4 and 12 | 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. | Baseline, Week 4 and Week 12 | 
| Change From Baseline in the International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) Score at Week 12 | 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. | Baseline, Week 12 | 
| Number of Participants With Each Categorical Response at Week 12 for Benefit, Satisfaction and Willingness to Continue (BSW) Questionnaire | 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). | Week 12 (or Early Withdrawal) | 
| Percentage of Participants Reporting Satisfaction on the Treatment Satisfaction Questionnaire (TSQ) at Week 12 | 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'. | Week 12 (or Early Withdrawal) | 
| Change From Baseline in King's Health Questionnaire (KHQ) Domain Scores at Week 12 | 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. | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fesoterodine, Open Label, Flexible Dose, OAB