We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00425100
First Posted: January 22, 2007
Last Update Posted: July 29, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Pfizer
January 19, 2007
January 22, 2007
October 10, 2008
February 10, 2009
July 29, 2009
January 2007
October 2007   (Final data collection date for primary outcome measure)
  • Mean Number of Micturition Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  • Mean Number of Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  • Mean Number of Urgency Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  • Number of Participants Reporting Satisfaction With Current Overactive Bladder (OAB) Treatment [ Time Frame: Week 12 ]
Patient satisfaction and overactive bladder (OAB) symptom improvement at the end of 12 weeks of fesoterodine treatment.
Complete list of historical versions of study NCT00425100 on ClinicalTrials.gov Archive Site
  • Nocturnal Micturitions Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  • Severe Urgency Episodes Per 24 Hours [ Time Frame: Baseline and Week 12 ]
  • Mean Rating on the Urinary Sensation Scale [ Time Frame: Baseline and Week 12 ]
  • Patient Perception of Bladder Condition (PPBC) Score [ Time Frame: Baseline and Week 12 ]
  • Patient Perception of Bladder Condition (PPBC) Score at Week 12 Relative to Baseline (Categorical Change) [ Time Frame: Baseline and Week 12 ]
  • Urgency Perception Scale (UPS) [ Time Frame: Baseline and Week 12 ]
  • Urgency Perception Scale (UPS) at Week 12 Relative to Baseline (Categorical Change) [ Time Frame: Baseline and Week 12 ]
  • Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Concern Domain [ Time Frame: Baseline and Week 12 ]
  • Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Coping Domain [ Time Frame: Baseline and Week 12 ]
  • Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Sleep Domain [ Time Frame: Baseline and Week 12 ]
  • Overactive Bladder Questionnaire (OAB-q) - Health Related Quality of Life (HRQL) Social Interaction Domain [ Time Frame: Baseline and Week 12 ]
  • Overactive Bladder Questionnaire (OAB-q) - Total Health Related Quality of Life (HRQL) Scale [ Time Frame: Baseline and Week 12 ]
  • Overactive Bladder Questionnaire (OAB-q) - Symptom Bother Scale [ Time Frame: Baseline and Week 12 ]
  • "Satisfaction With OAB Control" Module of Overactive Bladder (OAB) Treatment Satisfaction Questionnaire (TSQ) (OAB-S) [ Time Frame: Week 12 ]
  • Sum Rating on the Urinary Sensation Scale [ Time Frame: Baseline and Week 12 ]
  • Treated Subjects Reporting Satisfaction With Their Current OAB Treatment (Supportive Analysis) [ Time Frame: Week 12 ]
Symptom improvement at weeks 1 and 4. Patient Reported Outcome at weeks 4 and 12.
Not Provided
Not Provided
 
A Clinical Trial To Assess Fesoterodine On Treatment Satisfaction And Symptom Improvement In Overactive Bladder Patients
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.
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Overactive Bladder
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.
Experimental: Open Label-fesoterodine
Single treatment study arm.
Intervention: Drug: fesoterodine fumarate
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
516
October 2007
October 2007   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Costa Rica,   Czech Republic,   Germany,   Korea, Republic of,   Poland,   Slovakia,   Ukraine,   United States
Norway
 
NCT00425100
A0221007
No
Not Provided
Not Provided
Director, Clinical Trial Disclosure Group, Pfizer, Inc.
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
February 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP