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

October 4, 2018 updated by: Pfizer

Observational Study In Patients With Overactive Bladder (OAB) Treated With Toviaz® After Failure Of Previous Antimuscarinic Therapy Due To Ineffectivity Or Intolerance.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

823

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Slovakia
      • ?a?a, Slovakia
        • Pfizer Investigational Site
      • Aa, Slovakia
        • Pfizer Investigational Site
      • Adca, Slovakia
        • Pfizer Investigational Site
      • B.Bystrica, Slovakia
        • Pfizer Investigational Site
      • Banska Bystrica, Slovakia, 974 01
        • Pfizer Investigational Site
      • Bardejov, Slovakia
        • Pfizer Investigational Site
      • Bratislava, Slovakia
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 82606
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 833 05
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 01
        • Pfizer Investigational Site
      • Bratislava, Slovakia, 851 05
        • Pfizer Investigational Site
      • Bratislava 2, Slovakia, 82109
        • Pfizer Investigational Site
      • Bratislava 2, Slovakia, 82606
        • Pfizer Investigational Site
      • Bratislava 4, Slovakia
        • Pfizer Investigational Site
      • Bratislava 5, Slovakia, 85104
        • Pfizer Investigational Site
      • Bratislava 5, Slovakia, 85107
        • Pfizer Investigational Site
      • Dolny Kubin, Slovakia
        • Pfizer Investigational Site
      • Dunajska Streda, Slovakia
        • Pfizer Investigational Site
      • Hlohovec, Slovakia
        • Pfizer Investigational Site
      • Humenne, Slovakia
        • Pfizer Investigational Site
      • Ilina, Slovakia
        • Pfizer Investigational Site
      • Koice, Slovakia
        • Pfizer Investigational Site
      • Koice-aca, Slovakia
        • Pfizer Investigational Site
      • Komarno, Slovakia
        • Pfizer Investigational Site
      • Kosice, Slovakia, 041 90
        • Pfizer Investigational Site
      • Kosice, Slovakia
        • Pfizer Investigational Site
      • Kraovsky Chlmec, Slovakia
        • Pfizer Investigational Site
      • Liptovsky Hradok, Slovakia
        • Pfizer Investigational Site
      • Liptovsky Mikulas, Slovakia
        • Pfizer Investigational Site
      • Luenec, Slovakia
        • Pfizer Investigational Site
      • Malacky, Slovakia, 901 01
        • Pfizer Investigational Site
      • Malacky, Slovakia, 90122
        • Pfizer Investigational Site
      • Martin, Slovakia
        • Pfizer Investigational Site
      • Michalovce, Slovakia
        • Pfizer Investigational Site
      • Myjava, Slovakia
        • Pfizer Investigational Site
      • Namestovo, Slovakia
        • Pfizer Investigational Site
      • Nitra, Slovakia, 949 01
        • Pfizer Investigational Site
      • Nitra, Slovakia, 951 01
        • Pfizer Investigational Site
      • Nitra, Slovakia
        • Pfizer Investigational Site
      • Nove Zamky, Slovakia
        • Pfizer Investigational Site
      • Nové Zámky, Slovakia
        • Pfizer Investigational Site
      • Piestany, Slovakia, 921 01
        • Pfizer Investigational Site
      • Poprad, Slovakia
        • Pfizer Investigational Site
      • Povaska Bystrica, Slovakia
        • Pfizer Investigational Site
      • Povazska Bystrica, Slovakia, 017 01
        • Pfizer Investigational Site
      • Preov, Slovakia
        • Pfizer Investigational Site
      • Prievidza, Slovakia
        • Pfizer Investigational Site
      • Puchov, Slovakia
        • Pfizer Investigational Site
      • Revuca, Slovakia
        • Pfizer Investigational Site
      • Rimavska Sobota, Slovakia
        • Pfizer Investigational Site
      • Ruomberok, Slovakia
        • Pfizer Investigational Site
      • Ruzomberok, Slovakia
        • Pfizer Investigational Site
      • Senica, Slovakia, 90501
        • Pfizer Investigational Site
      • Skalica, Slovakia, 90901
        • Pfizer Investigational Site
      • Sobrance, Slovakia
        • Pfizer Investigational Site
      • SpisskaNova Ves, Slovakia
        • Pfizer Investigational Site
      • Stropkov, Slovakia
        • Pfizer Investigational Site
      • Svidnik, Slovakia
        • Pfizer Investigational Site
      • Topoany, Slovakia
        • Pfizer Investigational Site
      • Trebisov, Slovakia
        • Pfizer Investigational Site
      • Trencin, Slovakia, 911 01
        • Pfizer Investigational Site
      • Trenin, Slovakia
        • Pfizer Investigational Site
      • Trnava, Slovakia
        • Pfizer Investigational Site
      • Turianske Teplice, Slovakia
        • Pfizer Investigational Site
      • Urany, Slovakia
        • Pfizer Investigational Site
      • Vrable, Slovakia
        • Pfizer Investigational Site
      • Vranov n/Topou, Slovakia
        • Pfizer Investigational Site
      • Zvolen, Slovakia
        • Pfizer Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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)

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
fesoterodine
Drug: fesoterodine
4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment
Other Names:
  • TOVIAZ

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit
Time Frame: Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Micturition frequency: mean number of 'day time' (i.e., the time the participant was awake) micturitions per 24 hours and calculated as the total number of 'day time' urinations, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or Early Termination (ET)
Change From Baseline in Nocturnal Micturition Frequency Per 24 Hours at Visit 2, Visit 3, and Visit 4
Time Frame: Baseline, Month 1, Month 2, Month 3 or ET
Nocturnal frequency: mean number of 'night time' (the time the participant was asleep and the urge to urinate woke him/her up) micturitions and calculated as the total number of 'night time' urinations, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Episode Frequency (UEF) Per 24 Hours at Visit 2, Visit 3, and Visit 4
Time Frame: Baseline, Month 1, Month 2, Month 3 or ET
UEF: mean number of micturition related urgency episodes per 24 hours and calculated as the total number of 'urgency' urinations (i.e., sudden urges to urinate and problems to delay micturition) divided by 3 (or if data for 3 days were not available, over the total number of diary days collected at that visit).
Baseline, Month 1, Month 2, Month 3 or ET
Change From Baseline in Urgency Urinary Incontinence (UUI) Episodes Per 24 Hours at Visit 2, Visit 3, and Visit 4
Time Frame: Baseline, Month 1, Month 2, Month 3 or ET
The mean number of UUI episodes: total number of UUI episodes, divided by the total diary days collected at that visit.
Baseline, Month 1, Month 2, Month 3 or ET

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4
Time Frame: Baseline, Month 1, Month 2, Month 3 or ET
The PVR urine volume: measured by an ultrasound scan.
Baseline, Month 1, Month 2, Month 3 or ET
Patient's Global Evaluation of Fesoterodine
Time Frame: Baseline, Month 3 or ET
The patients global evaluation of study medication was assessed via the question 'how would you rate your overall response to the study medication?' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent'.
Baseline, Month 3 or ET
Clinical Global Evaluation of Fesoterodine
Time Frame: 12 weeks
Clinical global evaluation of study medication was assessed via the question 'how would you rate the study medication the patient received for overactive bladder?,' and was assessed on the four point categorical scale, ranging from 'Poor' to 'Excellent.'
12 weeks
Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4
Time Frame: Month 3 or ET
Overall Treatment Effect Scale: 3 questions from which a numeric score was derived. If a subject answered '(2) About the same' to question 1 then a score of 0 was given. If a subject answered '(1) Worse' to question 1, then a score between -7=a very great deal worse to -1=Almost the same, hardly worse at all was given depending on severity of their symptoms (determined from answer to question 2). If a subject answered '(3) Better' to question 1, then a score ranging from 1=Almost the same, hardly better at all to 7=A very great deal better, depending on their answer to question 3, was given.
Month 3 or ET
Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale
Time Frame: Baseline, Month 3 or ET
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Baseline, Month 3 or ET
Change From Baseline in Total Scores of OAB-q at Visit 4
Time Frame: Baseline, Month 3 or ET
Symptom severity/bother score: sub-section of the OAB-q consists of 8 questions. Each item assessed on ordinal scale (0=Not at all to 5=a very great deal). Score=sum of scores for items 1 to 8 and a further 2 points were added if subject was male. Lowest possible score=0 and highest=42. Data were transformed onto a 0 to 100 scale and analyzed based on the transformed score: Transformed Symptom Bother Score=[(Actual Total Raw Score minus Lowest possible value of raw score) divided by Range] multiplied by 100. Higher scores=greater symptom severity or bother and lower=minimal symptom severity.
Baseline, Month 3 or ET
Time To Onset Of Treatment Response
Time Frame: Month 1, Month 2, Month 3 or ET
Participant's perception of treatment response assessment since the previous visit was noted at each visit. Time to onset of response was calculated in weeks from start of treatment.
Month 1, Month 2, Month 3 or ET
Study Doses
Time Frame: Month 3 or ET
Number of subjects that changed doses throughout the study period.
Month 3 or ET
Reasons for Study Treatment Dose Changes
Time Frame: Month 3 or ET
Possible change in the dose and the reasons for the change were collected and documented.
Month 3 or ET

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2008

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

June 3, 2008

First Submitted That Met QC Criteria

June 4, 2008

First Posted (Estimate)

June 5, 2008

Study Record Updates

Last Update Posted (Actual)

November 2, 2018

Last Update Submitted That Met QC Criteria

October 4, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • A0221059

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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