Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy

NCT00691093

Last updated date
Study Location
Pfizer Investigational Site
?a?a, , , Slovakia
Contact
1-800-718-1021

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1-800-718-1021

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[email protected]

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Overactive Bladder, Urinary Incontinence
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Patients older than 18 years

- Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.

- Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ≥2 per day subjectively perceived as bothersome

- Due to intolerance: persistent and/or unacceptable adverse events

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Hypersensitivity to the active substance or to peanut or soya or any of the
excipients.


- History of acute urinary retention (requiring catheterisation)


- Gastric retention


- Uncontrolled narrow angle glaucoma


- Myasthenia gravis


- Severe hepatic impairment (Child Pugh C)


- Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe
hepatic or renal impairment


- Severe ulcerative colitis


- Toxic megacolon.

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Overactive Bladder, Urinary IncontinenceStudy In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
NCT00691093
  1. ?a?a,
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  4. B.Bystrica,
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  6. Bardejov,
  7. Bratislava 2,
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  68. Zvolen,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title Study In Patients With Overactive Bladder Treated With Toviaz® After Failure Of Previous Therapy
Official Title Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.
Brief Summary This is a observational study in patients treated with fesoterodine (Toviaz), who have failed on previous treatment for overactive bladder. It will collect epidemiological data and investigate the efficacy and tolerability of fesoterodine.
Detailed Description patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients older than 18 years with overactive bladder after failure of previous antimuscarinic therapy (due to lack of efficacy or intolerance)
Condition
  • Overactive Bladder
  • Urinary Incontinence
Intervention Drug: fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
Other Name: TOVIAZ
Study Groups/Cohorts fesoterodine
Intervention: Drug: fesoterodine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: October 21, 2010)
823
Original Estimated Enrollment
 (submitted: June 4, 2008)
700
Actual Study Completion Date June 2009
Actual Primary Completion Date June 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients older than 18 years
  • Patients with OAB after failure of previous antimuscarinic therapy - due to lack of efficacy: persistence of storage symptoms.
  • Required symptoms: micturition frequency 8 and more / 24 hours and urgency episodes ?2 per day subjectively perceived as bothersome
  • Due to intolerance: persistent and/or unacceptable adverse events

Exclusion Criteria:

  • Hypersensitivity to the active substance or to peanut or soya or any of the excipients.
  • History of acute urinary retention (requiring catheterisation)
  • Gastric retention
  • Uncontrolled narrow angle glaucoma
  • Myasthenia gravis
  • Severe hepatic impairment (Child Pugh C)
  • Concomitant use of potent CYP3A4 inhibitors in subjects with moderate to severe hepatic or renal impairment
  • Severe ulcerative colitis
  • Toxic megacolon.
Sex/Gender
Sexes Eligible for Study:All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Slovakia
Removed Location Countries  
 
Administrative Information
NCT Number NCT00691093
Other Study ID Numbers A0221059
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2018