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

Overactive Bladder Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00425100
• Other study ID #: A0221007
• Status: Completed
• Phase: Phase 3
• Start date: January 2007
• Est. completion date: October 2007

Study information

• Verified date: November 2018
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 516
• Est. completion date: October 2007
• Est. primary completion date: October 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Overactive Bladder
• Urinary Bladder, Overactive

Intervention

Drug:
• fesoterodine fumarate
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.

Locations

Country	Name	City	State
Belgium	Pfizer Investigational Site	Bruxelles
Belgium	Pfizer Investigational Site	Edegem
Belgium	Pfizer Investigational Site	Gent
Belgium	Pfizer Investigational Site	Jette
Belgium	Pfizer Investigational Site	Turnhout
Costa Rica	Pfizer Investigational Site	Alajuela Centro	Alajuela
Costa Rica	Pfizer Investigational Site	San Jose
Czechia	Pfizer Investigational Site	Brno-Bohunice
Czechia	Pfizer Investigational Site	Hradec Kralove
Czechia	Pfizer Investigational Site	Praha 2
Czechia	Pfizer Investigational Site	Praha 5
Germany	Pfizer Investigational Site	Alzey
Germany	Pfizer Investigational Site	Berlin
Germany	Pfizer Investigational Site	Duisburg
Germany	Pfizer Investigational Site	Frankfurt
Germany	Pfizer Investigational Site	Marburg
Germany	Pfizer Investigational Site	Muelheim A.d. Ruhr
Germany	Pfizer Investigational Site	Muenchen
Korea, Republic of	Pfizer Investigational Site	Bucheon-si	Gyunggi-do
Korea, Republic of	Pfizer Investigational Site	Busan
Korea, Republic of	Pfizer Investigational Site	Daejeon
Korea, Republic of	Pfizer Investigational Site	Jeonnam
Korea, Republic of	Pfizer Investigational Site	Seoul
Korea, Republic of	Pfizer Investigational Site	Seoul
Poland	Pfizer Investigational Site	Lodz
Poland	Pfizer Investigational Site	Myslowice
Slovakia	Pfizer Investigational Site	Bratislava
Slovakia	Pfizer Investigational Site	Malacky
Slovakia	Pfizer Investigational Site	Piestany
Slovakia	Pfizer Investigational Site	Presov
Slovakia	Pfizer Investigational Site	Skalica
Ukraine	Pfizer Investigational Site	Chernivtsi
Ukraine	Pfizer Investigational Site	Dnipropetrovsk
Ukraine	Pfizer Investigational Site	Kharkiv
Ukraine	Pfizer Investigational Site	Odessa
Ukraine	Pfizer Investigational Site	Zaporizhzhia
United States	Pfizer Investigational Site	Aurora	Colorado
United States	Pfizer Investigational Site	Aurora	Illinois
United States	Pfizer Investigational Site	Bethany	Oklahoma
United States	Pfizer Investigational Site	Cincinnati	Ohio
United States	Pfizer Investigational Site	Eugene	Oregon
United States	Pfizer Investigational Site	Homewood	Alabama
United States	Pfizer Investigational Site	Houston	Texas
United States	Pfizer Investigational Site	Huntsville	Alabama
United States	Pfizer Investigational Site	Kingston	New York
United States	Pfizer Investigational Site	La Mesa	California
United States	Pfizer Investigational Site	Milford	Massachusetts
United States	Pfizer Investigational Site	Milwaukee	Wisconsin
United States	Pfizer Investigational Site	New York	New York
United States	Pfizer Investigational Site	Omaha	Nebraska
United States	Pfizer Investigational Site	Orangevale	California
United States	Pfizer Investigational Site	Poughkeepsie	New York
United States	Pfizer Investigational Site	Pratt	Kansas
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Salt Lake City	Utah
United States	Pfizer Investigational Site	Sellersville	Pennsylvania
United States	Pfizer Investigational Site	Shreveport	Louisiana
United States	Pfizer Investigational Site	West Palm Beach	Florida
United States	Pfizer Investigational Site	Westampton	New Jersey
United States	Pfizer Investigational Site	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Countries where clinical trial is conducted

United States,  Belgium,  Costa Rica,  Czechia,  Germany,  Korea, Republic of,  Poland,  Slovakia,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	"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
Secondary	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
Secondary	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

External Links

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