Non-Interventional Study To Investigate Whether Information Provided To Patients Influences Their Satisfaction With Toviaz Therapy

NCT01091519 | Terminated Results

• 2 other identifiers: A0221073FACTS (FAKTEN) study
• Study Type: observational
• Target: 781
• Locations: 0 countries
• Sites: N/A

Brief Summary

Collect information on treatment with Toviaz (fesoterodine) under ordinary prescribing conditions, and to investigate whether additional educational information affects satisfaction with treatment as perceived by the patient.

Conditions

Urinary Bladder, Overactive

Keywords

Non-interventional study fesoterodine educational materials

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Satisfied With Treatment at Month 4

  Participant's response to treatment was based on treatment satisfaction questionnaires (TSQ). Participants answered: "overall, how satisfied are you with your OAB medication?" and were asked to rate this question on 5 point scale as 1=very satisfied, 2=somewhat satisfied, 3= neither dissatisfied nor satisfied, 4=somewhat dissatisfied and 5=very dissatisfied. Five categorical responses were grouped to satisfied (including "very satisfied" and "somewhat satisfied") and dissatisfied (including "very dissatisfied", "somewhat dissatisfied", and "neither dissatisfied nor satisfied").

  Month 4

Secondary Outcomes (3)

• Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4

  Baseline, Week 4, Month 4

• Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4

  Baseline, Week 4, Month 4

• Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4

  Baseline, Week 4, Month 4

Study Arms (2)

Toviaz(fesoterodine) plus educational materials

Other: Toviaz(fesoterodine) plus educational materials

Toviaz(fesoterodine) alone

Toviaz(fesoterodine) without additional educational materials

Other: Toviaz(fesoterodine) without educational materials

Interventions

Toviaz(fesoterodine) plus educational materials OTHER

Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue.

Toviaz(fesoterodine) plus educational materials

Toviaz(fesoterodine) without educational materials OTHER

No educational materials

Toviaz(fesoterodine) alone

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 with overactive bladder symptoms presenting during routine clinical practice visits

You may qualify if:

• Patients with increased urinary frequency and/or imperative urgency and/or urge incontinence, as can occur in patients with overactive bladder syndrome, for whom Toviaz was prescribed for treatment of the symptoms.
• Patients will complete the OABv8 questionnaire and will need to meet a minimum score in order to be eligible for the study.

You may not qualify if:

• Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.

Sponsors & Collaborators

• Pfizer: lead

Related Publications (1)

• Schneider T, Arumi D, Crook TJ, Sun F, Michel MC. An observational study of patient satisfaction with fesoterodine in the treatment of overactive bladder: effects of additional educational material. Int J Clin Pract. 2014 Sep;68(9):1074-80. doi: 10.1111/ijcp.12450. Epub 2014 May 5.

  PMID: 24797765 DERIVED

Related Links

• To obtain contact information for a study center near you, click here.

MeSH Terms

Conditions

Urinary Bladder, Overactive

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

Limitations and Caveats

This was an open label observational study in Germany, which was stopped early due to low participant recruitment rates. The results should therefore be interpreted with caution due to the lower than planned sample size.

Results Point of Contact

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

ClinicalTrials.gov_Inquiries@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
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2010
• First Posted: March 24, 2010
• Study Start: December 1, 2010
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: March 7, 2013
• Results First Posted: March 7, 2013

Record last verified: 2013-01