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| ID | Type | Description | Link |
|---|---|---|---|
| FACTS (FAKTEN) study |
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See termination reason in detailed description.
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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.
Patients will be identified and monitored during routine clinical practice visits, and will not be specifically selected as this would interfere with the representativeness of the results. The study will be conducted with office-based urologists and office-based general physicians, practitioners and internists (GPs) in Germany, thus representing a wide range of practices and populations. Each urologist or GP may invite patients to participate who have already been diagnosed with overactive bladder and prescribed Toviaz according to their usual standard of care. Study enrollment stopped on December 31, 2011 due to difficulty in recruiting patients. No safety issues were related to the decision to stop patient enrollment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Toviaz(fesoterodine) plus educational materials |
| ||
| Toviaz(fesoterodine) alone | Toviaz(fesoterodine) without additional educational materials |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Toviaz(fesoterodine) plus educational materials | Other | Educational materials including the Self-Assessment Goal Achievement (SAGA) tool to support dialogue. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2). |
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Inclusion Criteria:
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.
Exclusion Criteria:
Patients who meet the contraindications in the Toviaz prescribing information (active ingredient fesoterodine) will be excluded.
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Patients with overactive bladder symptoms presenting during routine clinical practice visits
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24797765 | Derived | 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. |
| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Fesoterodine With Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Toviaz(fesoterodine) without educational materials | Other | No educational materials |
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| 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 | PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: "Which of the following would typically describe your experience when you have a desire to urinate?" 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change). | Baseline, Week 4, Month 4 |
| Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: "overall how satisfied are you with your over active bladder (OAB) medication?" 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2). | Baseline, Week 4, Month 4 |
| FG001 | Fesoterodine Without Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. |
| Treated |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Fesoterodine With Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months. |
| BG001 | Fesoterodine Without Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | For baseline characteristic age and gender, number of participants evaluable was 751. | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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"). | Full Analysis Set (FAS) included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. | Posted | Number | 95% Confidence Interval | percentage of participants | Month 4 |
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| Secondary | Number of Participants With Change From Baseline in Patient Perception of Bladder Condition (PPBC) at Week 4 and Month 4 | PPBC: single-item, self-administered validated questionnaire. Rated on a 6-point scale: participant was asked: "Which of the following statements describes your bladder condition best at the moment?" 1=no problems at all; 2=some very minor problems; 3=some minor problems; 4=some moderate problems; 5=severe problems; 6=many severe problems. Change from baseline results categorized as deterioration (Positive change from baseline); no Change (scores change=0); minor Improvement (negative score change in magnitude of 1); major improvement (negative score change in magnitude of >=2). | FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point. | Posted | Number | participants | Baseline, Week 4, Month 4 |
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| Secondary | Number of Participants With Change From Baseline in Patient Perception of Urgency Scale (PPUS) at Week 4 and Month 4 | PPUS: single-item, self-administered validated questionnaire. Rated on a 3-point scale: participant was asked: "Which of the following would typically describe your experience when you have a desire to urinate?" 1=usually not able to hold urine; 2=usually able to hold urine (without leaking) until I reach a toilet if I go to the toilet immediately; 3= usually able to finish what I am doing before going to the toilet (without leaking). Change from baseline results categorized as deterioration (Negative change); no change (Score change=0); improvement (Positive change). | FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point. | Posted | Number | participants | Baseline, Week 4, Month 4 |
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| Secondary | Number of Participants With Change From Baseline in Treatment Satisfaction Question (TSQ) at Week 4 and Month 4 | Participant's response to the treatment was based on treatment satisfaction questionnaires (TSQ). TSQ was rated on a 5-point scale, participant was asked: "overall how satisfied are you with your over active bladder (OAB) medication?" 1=very satisfied, 2=somewhat satisfied, 3=neither dissatisfied nor satisfied, 4=somewhat dissatisfied, 5=very dissatisfied. Change from baseline results categorized as deterioration (Positive change from baseline);no change (scores change=0);minor improvement (negative score change in magnitude of 1);major improvement (negative score change in magnitude of >=2). | FAS included all participants who had received at least 1 dose of study medication and had provided at least 1 efficacy endpoint at baseline and during the study. Here, 'N' (number of participants analyzed) signifies those participants who were evaluable for this measure. n=number of participants evaluable for this measure at specified time point. | Posted | Number | participants | Baseline, Week 4, Month 4 |
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Same event may appear as both AE and SAE but distinct events are presented. An event may be categorized as serious in 1 subject, nonserious in another, or 1 subject may experience both serious, nonserious event. Safety population:participants who were randomized to with/without participant educational materials, had dose of prescription medication.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Fesoterodine With Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, with educational materials comprising of Self Assessment Goal Achievement (SAGA) tool. This tool included information to help the participants and follow their own treatment goals, as well as educational material on overactive bladder (OAB). Participants were observed for 4 months. | 2 | 342 | 25 | 342 | ||
| EG001 | Fesoterodine Without Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. | 1 | 431 | 36 | 431 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Convulsion | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Spinal osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiovascular disorder | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Tachycardia | Cardiac disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Vertigo | Ear and labyrinth disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Accommodation disorder | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Glaucoma | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Oscillopsia | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Dysphagia | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Faeces hard | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
| |
| Gastric disorder | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Gastritis | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Adverse event | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Face oedema | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Mucosal dryness | General disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA v15.0 | Non-systematic Assessment |
| |
| Bladder cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA v15.0 | Non-systematic Assessment |
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| Headache | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Somnolence | Nervous system disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Initial insomnia | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Sleep disorder | Psychiatric disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Oliguria | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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| Dry skin | Skin and subcutaneous tissue disorders | MedDRA v15.0 | Non-systematic Assessment |
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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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D053201 | Urinary Bladder, Overactive |
| ID | Term |
|---|---|
| D001745 | Urinary Bladder Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Title | Measurements |
|---|---|
|
| 45 to 64 years |
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| Greater than or equal to (>=) 65 years |
|
| Male |
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| OG001 | Fesoterodine Without Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. |
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| OG001 | Fesoterodine Without Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. |
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| OG001 | Fesoterodine Without Educational Materials | Participants received prescription fesoterodine (Toviaz), which was guided by medical and therapeutic needs. Additionally all participants were provided with patient reported outcomes (PROs) for completion, without educational materials. Participants were observed for 4 months. |
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