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

Primary Purpose

Overactive Bladder

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
fesoterodine fumarate
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Overactive Bladder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site
  • Pfizer Investigational Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open Label-fesoterodine

Arm Description

Single treatment study arm.

Outcomes

Primary Outcome Measures

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.
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.
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.
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.

Secondary Outcome Measures

Nocturnal Micturitions Per 24 Hours
Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.
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.
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."
Patient Perception of Bladder Condition (PPBC) Score
The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."
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
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]").
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Improvement: positive score change; No improvement: zero or negative score change
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.
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.
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.
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.
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.
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.
"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.
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."
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.

Full Information

First Posted
January 19, 2007
Last Updated
November 7, 2018
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT00425100
Brief Title
A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
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.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Completed
Study Start Date
January 2007 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Pfizer

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Overactive Bladder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
516 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Open Label-fesoterodine
Arm Type
Experimental
Arm Description
Single treatment study arm.
Intervention Type
Drug
Intervention Name(s)
fesoterodine fumarate
Intervention Description
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.
Primary Outcome Measure Information:
Title
Mean Number of Micturition Episodes Per 24 Hours
Description
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.
Time Frame
Baseline and Week 12
Title
Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours
Description
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.
Time Frame
Baseline and Week 12
Title
Mean Number of Urgency Episodes Per 24 Hours
Description
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.
Time Frame
Baseline and Week 12
Title
Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment
Description
Number of Participants who responded satisfied = (very satisfied or somewhat satisfied) and dissatisfied = (somewhat dissatisfied or very dissatisfied) to the treatment satisfaction question.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Nocturnal Micturitions Per 24 Hours
Description
Nocturnal micturitions (synonymous with the term "nighttime micturitions") were those recorded in the bedtime section of the bladder diary.
Time Frame
Baseline and Week 12
Title
Severe Urgency Episodes Per 24 Hours
Description
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.
Time Frame
Baseline and Week 12
Title
Mean Rating on the Urinary Sensation Scale
Description
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."
Time Frame
Baseline and Week 12
Title
Patient Perception of Bladder Condition (PPBC) Score
Description
The PPBC score ranges from 1 "no problems at all" to 6 "many severe problems."
Time Frame
Baseline and Week 12
Title
Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change)
Description
Improvement: negative score change; No change: score change=0; Deterioration: positive score change
Time Frame
Baseline and Week 12
Title
Urgency Perception Scale (UPS)
Description
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]").
Time Frame
Baseline and Week 12
Title
Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change)
Description
Improvement: positive score change; No improvement: zero or negative score change
Time Frame
Baseline and Week 12
Title
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain
Description
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.
Time Frame
Baseline and Week 12
Title
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain
Description
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.
Time Frame
Baseline and Week 12
Title
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain
Description
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.
Time Frame
Baseline and Week 12
Title
Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain
Description
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.
Time Frame
Baseline and Week 12
Title
Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale
Description
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.
Time Frame
Baseline and Week 12
Title
Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale
Description
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.
Time Frame
Baseline and Week 12
Title
"Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S)
Description
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.
Time Frame
Week 12
Title
Sum Rating on the Urinary Sensation Scale
Description
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."
Time Frame
Baseline and Week 12
Title
Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis)
Description
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.
Time Frame
Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Pfizer Investigational Site
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Pfizer Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Pfizer Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Pfizer Investigational Site
City
Orangevale
State/Province
California
ZIP/Postal Code
95662
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Pfizer Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Pfizer Investigational Site
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60504
Country
United States
Facility Name
Pfizer Investigational Site
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Pfizer Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71106
Country
United States
Facility Name
Pfizer Investigational Site
City
Milford
State/Province
Massachusetts
ZIP/Postal Code
01757
Country
United States
Facility Name
Pfizer Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Pfizer Investigational Site
City
Westampton
State/Province
New Jersey
ZIP/Postal Code
08060
Country
United States
Facility Name
Pfizer Investigational Site
City
Kingston
State/Province
New York
ZIP/Postal Code
12401
Country
United States
Facility Name
Pfizer Investigational Site
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Pfizer Investigational Site
City
Poughkeepsie
State/Province
New York
ZIP/Postal Code
12601
Country
United States
Facility Name
Pfizer Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Pfizer Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Pfizer Investigational Site
City
Bethany
State/Province
Oklahoma
ZIP/Postal Code
73008
Country
United States
Facility Name
Pfizer Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
Pfizer Investigational Site
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Pfizer Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Pfizer Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84124
Country
United States
Facility Name
Pfizer Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Pfizer Investigational Site
City
Bruxelles
ZIP/Postal Code
B-1200
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Edegem
ZIP/Postal Code
B-2650
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Gent
ZIP/Postal Code
B-9000
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Jette
ZIP/Postal Code
B-1090
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Turnhout
ZIP/Postal Code
B-2300
Country
Belgium
Facility Name
Pfizer Investigational Site
City
Alajuela Centro
State/Province
Alajuela
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
San Jose
Country
Costa Rica
Facility Name
Pfizer Investigational Site
City
Brno-Bohunice
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Praha 5
ZIP/Postal Code
152 00
Country
Czechia
Facility Name
Pfizer Investigational Site
City
Alzey
ZIP/Postal Code
55232
Country
Germany
Facility Name
Pfizer Investigational Site
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Pfizer Investigational Site
City
Duisburg
ZIP/Postal Code
47179
Country
Germany
Facility Name
Pfizer Investigational Site
City
Frankfurt
ZIP/Postal Code
65929
Country
Germany
Facility Name
Pfizer Investigational Site
City
Marburg
ZIP/Postal Code
35039
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muelheim A.d. Ruhr
ZIP/Postal Code
45468
Country
Germany
Facility Name
Pfizer Investigational Site
City
Muenchen
ZIP/Postal Code
81925
Country
Germany
Facility Name
Pfizer Investigational Site
City
Bucheon-si
State/Province
Gyunggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Daejeon
ZIP/Postal Code
301-721
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Jeonnam
ZIP/Postal Code
519-809
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
Pfizer Investigational Site
City
Lodz
ZIP/Postal Code
93-316
Country
Poland
Facility Name
Pfizer Investigational Site
City
Myslowice
ZIP/Postal Code
41-400
Country
Poland
Facility Name
Pfizer Investigational Site
City
Bratislava
ZIP/Postal Code
833 05
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Malacky
ZIP/Postal Code
901 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Piestany
ZIP/Postal Code
921 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Presov
ZIP/Postal Code
080 01
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Skalica
ZIP/Postal Code
909 82
Country
Slovakia
Facility Name
Pfizer Investigational Site
City
Chernivtsi
ZIP/Postal Code
58002
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Dnipropetrovsk
ZIP/Postal Code
49005
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Odessa
ZIP/Postal Code
65000
Country
Ukraine
Facility Name
Pfizer Investigational Site
City
Zaporizhzhia
ZIP/Postal Code
69000
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
19348029
Citation
Wyndaele JJ, Goldfischer ER, Morrow JD, Gong J, Tseng LJ, Guan Z, Choo MS. Effects of flexible-dose fesoterodine on overactive bladder symptoms and treatment satisfaction: an open-label study. Int J Clin Pract. 2009 Apr;63(4):560-7. doi: 10.1111/j.1742-1241.2009.02035.x.
Results Reference
derived
Links:
URL
https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=A0221007&StudyName=A%20Clinical%20Trial%20To%20Assess%20Fesoterodine%20On%20Treatment%20Satisfaction%20And%20Symptom%20Improvement%20In%20Overactive%20Bladder%20Patients
Description
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A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients

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