Toviaz Post Marketing Surveillance Study

Completed

Conditions: Overactive Bladder

Interventions: Drug: Toviaz treatment

Registration Number: NCT00879398

Lead Sponsor: Pfizer

Brief Summary: The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.

Detailed Description: continuous registration method

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 3000

Inclusion Criteria

Subjects who are diagnosed as Overactive Bladder (OAB) defined as urgency, with or without urgency incontinence, usually with frequency and nocturia, in the absence of local or metabolic factors explaining these factors.

Exclusion Criteria

Hypersensitivity to the active substance or to peanut or soya or any of the excipients
Urinary retention
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
Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption (Toviaz® prolonged-release tablets contain lactose)

Study & Design

Study Type: OBSERVATIONAL

Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
OAB-Toviaz	Toviaz treatment	All patients who enrolled in this study

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)	From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.	An AE was any untoward medical occurrence in a clinical investigation subject administered a product or medical device; the event was not necessarily had a causal relationship with the treatment or usage. All AEs reported after start of administration of Toviaz were considered as TEAEs.
Investigator's Final Assessment of Effectiveness at the End of Study Treatment	At the end of study treatment	The final efficacy assessment included improvement, no change, aggravation, and unevaluable evaluated by the investigator based on the subject's symptoms of frequent micturition, urgency, and urgency urinary incontinence (UUI).

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Number of Micturitions Per 24 Hours at the End of Study Treatment	Baseline and at the end of study treatment	The number of micturitions per 24 hours was recorded in the case report form (CRF) by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Change From Baseline in Number of Urgency Episodes Per 24 Hours at the End of Study Treatment	Baseline and at the end of study treatment	The number of urgency episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Change From Baseline in Number of UUI Episodes Per 24 Hours at the End of Study Treatment	Baseline and at the end of study treatment	The number of UUI episodes per 24 hours was recorded in the CRF by the investigator. Baseline was defined as data collected within 1 week prior to the first visit.
Participant Perception of Bladder Condition at the End of Study Treatment	Baseline and at the end of study treatment	Participant perception of bladder condition was recorded in the CRF by the investigator. Participants were asked at baseline (BL) and at the end of study treatment (EOT) if the extent to which their bladder condition caused them problems. The possible responses were: No Problem, Very Minor Problems, Minor Problems, Moderate Problems, Severe Problems, or Many Severe Problems.
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics	At the end of study treatment	Participants who were assessed as having improved from their baseline condition in the final efficacy assessment were considered as "effective". Baseline and treatment characteristics included: geriatric status (\<65 years or ≥65 years), age categories, gender, weight categories, height categories, allergic history, duration of disease, past overactive bladder (OAB) treatment history, medical history, kidney and liver disorders, concomitant medication, total administration period of Toviaz, completion status, daily dose of Toviaz, and long term administration of Toviaz (\<274 days and ≥274 days) .

Trial Locations

Locations (75): Hankook General Hospital
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Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Shin Urology Clinic
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Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Lee Urology Clinic
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Namyangju-si, Gyeonggi-do, Korea, Republic of
Soo Urology Clinic
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Asan-si, Chungcheongnam-do, Korea, Republic of
Seo Kyung-Keun Urology Clinic
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Cheonan-si, Chungcheongnam-do, Korea, Republic of
Cheonan Medical Center
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Cheonan-Si, Chungcheongnam-do, Korea, Republic of
Song In-Ho Urology Clinic
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Dangjin-si, Chungcheongnam-Do, Korea, Republic of
Seoul Urology Clinic
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Seongnam, Gyeonggi-Do, Korea, Republic of
Moa gynecology
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Nonsan-si, Chungcheongnam-do, Korea, Republic of
Jung Woong Gyo Urology Clinic
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Wonju-si, Gangwon-do, Korea, Republic of
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Hankook General Hospital
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of