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

NCT00691093 | Completed Results

• 1 other identifier: A0221059
• Study Type: observational
• Target: 823
• Locations: 1 country
• Sites: 65

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.

Conditions

Overactive Bladder; Urinary Incontinence

Keywords

observational

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Micturition Frequency Per 24 Hours at Each Visit

  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

  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

  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

  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 Outcomes (9)

• Change From Baseline in Post Void Residual (PVR) Urine Volume at Visit 2, Visit 3, and Visit 4

  Baseline, Month 1, Month 2, Month 3 or ET

• Patient's Global Evaluation of Fesoterodine

  Baseline, Month 3 or ET

• Clinical Global Evaluation of Fesoterodine

  12 weeks

• Efficacy and Tolerability Compared to Previous Medication (Overall Treatment Effect Scale) at Visit 4

  Month 3 or ET

• Overactive Bladder Questionnaire (OAB-q): Symptom Severity/Bother Scale

  Baseline, Month 3 or ET

Study Arms (1)

fesoterodine

Drug: fesoterodine

Interventions

fesoterodine DRUG

4 mg per 24 hours, possibility to increase to 8 mg depending on efficacy chronic treatment

Also known as: TOVIAZ

fesoterodine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pfizer: lead

Study Sites (65)

Pfizer Investigational Site

?a?a, Slovakia

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Pfizer Investigational Site

Aa, Slovakia

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Pfizer Investigational Site

Adca, Slovakia

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B.Bystrica, Slovakia

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Pfizer Investigational Site

Banská Bystrica, 974 01, Slovakia

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Bardejov, Slovakia

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Bratislava, 82109, Slovakia

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Bratislava, 82606, Slovakia

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Bratislava, 833 05, Slovakia

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Bratislava, 851 01, Slovakia

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Bratislava, 851 05, Slovakia

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Bratislava, 85104, Slovakia

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Bratislava, 85107, Slovakia

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Bratislava, Slovakia

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Dolný Kubín, Slovakia

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Dunajská Streda, Slovakia

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Hlohovec, Slovakia

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Humenné, Slovakia

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Ilina, Slovakia

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Koice-aca, Slovakia

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Koice, Slovakia

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Komárno, Slovakia

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Košice, 041 90, Slovakia

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Košice, Slovakia

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Kraovsky Chlmec, Slovakia

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Liptovský Hrádok, Slovakia

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Liptovský Mikuláš, Slovakia

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Luenec, Slovakia

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Malacky, 901 01, Slovakia

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Malacky, 90122, Slovakia

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Martin, Slovakia

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Michalovce, Slovakia

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Myjava, Slovakia

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Námestovo, Slovakia

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Nitra, 949 01, Slovakia

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Nitra, 951 01, Slovakia

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Nitra, Slovakia

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Nové Zámky, Slovakia

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Piešťany, 921 01, Slovakia

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Poprad, Slovakia

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Povaska Bystrica, Slovakia

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Považská Bystrica, 017 01, Slovakia

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Preov, Slovakia

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Prievidza, Slovakia

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Púchov, Slovakia

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Revúca, Slovakia

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Rimavská Sobota, Slovakia

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Ruomberok, Slovakia

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Ružomberok, Slovakia

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Senica, 90501, Slovakia

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Skalica, 90901, Slovakia

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Sobrance, Slovakia

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SpisskaNova Ves, Slovakia

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Stropkov, Slovakia

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Svidník, Slovakia

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Topoany, Slovakia

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Trebišov, Slovakia

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Pfizer Investigational Site

Trenčín, 911 01, Slovakia

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Trenin, Slovakia

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Trnava, Slovakia

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Turianske Teplice, Slovakia

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Urany, Slovakia

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Vranov n/Topou, Slovakia

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Vráble, Slovakia

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Pfizer Investigational Site

Zvolen, Slovakia

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MeSH Terms

Conditions

Urinary Bladder, Overactive; Urinary Incontinence

Interventions

fesoterodine

Condition Hierarchy (Ancestors)

Urinary Bladder Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Urination Disorders

Results Point of Contact

• Title: Pfizer ClinicalTrials.gov Call Center
• Organization: Pfizer, Inc.

ClinicalTrials.govCallCenter@pfizer.com

1-800-718-1021

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2008
• First Posted: June 5, 2008
• Study Start: July 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 2, 2018
• Results First Posted: November 18, 2010

Record last verified: 2018-10

Locations

SL (65)