Toviaz Post Marketing Surveillance Study
- 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
- 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.
- 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
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Lee Urology Clinic
🇰🇷Namyangju-si, Gyeonggi-do, Korea, Republic of
Moa gynecology
🇰🇷Nonsan-si, Chungcheongnam-do, Korea, Republic of
Kim Tae Joon Internal Medicine
🇰🇷Ansan-si, Gyeonggi-Do, Korea, Republic of
Ansan Themapark Medical Center
🇰🇷Ansan, Gyeonggi-Do, Korea, Republic of
Hwang Family Medicine Clinic
🇰🇷Goyang-Si, Gyeonggi-Do, Korea, Republic of
Na Seung Soo Urology Clinic
🇰🇷Seongnam-si, Gyeonggi-Do, Korea, Republic of
Kim Dae Sung Clinic
🇰🇷Uijeongbu-si, Gyeonggi-Do, Korea, Republic of
Lim Urology Clinic
🇰🇷Seoul, Korea, Republic of
Johan Urology Clinic
🇰🇷Uijeongbu-si, Gyeonggi-do, Korea, Republic of
Taepyung urology clinic
🇰🇷Daejeon, Korea, Republic of
Chung Duck Young Urology Clinic
🇰🇷Daejeon, Korea, Republic of
Incheonsarang Hospital
🇰🇷Incheon, Korea, Republic of
Yeonhap Urology Clinic
🇰🇷Daejeon, Korea, Republic of
Kim Se Gyeom Urology Clinic
🇰🇷Daejeon, Korea, Republic of
Park Urology Clinic
🇰🇷Incheon, Korea, Republic of
Songdo Hospital
🇰🇷Seoul, Korea, Republic of
Yonsei Woono Urology Clinic
🇰🇷Seoul, Korea, Republic of
Bae Urology Hospital
🇰🇷Seoul, Korea, Republic of
Song Woung Soeg Urology Clinic
🇰🇷Seoul, Korea, Republic of
Uh's Urology Clinic
🇰🇷Seoul, Korea, Republic of
Hong Don Ho Urology Clinic
🇰🇷Seoul, Korea, Republic of
Choi Urology Hospital
🇰🇷Seoul, Korea, Republic of
Gimpo Woori Hospital
🇰🇷Gimpsi, Gyeonggi-do, Korea, Republic of
Shin Urology Clinic
🇰🇷Cheongju-si, Chungcheongbuk-do, Korea, Republic of
Seo Kyung-Keun Urology Clinic
🇰🇷Cheonan-si, Chungcheongnam-do, Korea, Republic of
Soo Urology Clinic
🇰🇷Asan-si, Chungcheongnam-do, Korea, Republic of
Myung Urology Hospital
🇰🇷Bucheon-si, Gyeonggi-Do, Korea, Republic of
Woosung Yusung Hospital
🇰🇷Ansan, Gyeonggi-Do, Korea, Republic of
Jung Woong Gyo Urology Clinic
🇰🇷Wonju-si, Gangwon-do, Korea, Republic of
Samsung Clinic
🇰🇷Goyang-si, Gyeonggi-Do, Korea, Republic of
Yoo And Lee Dematology Urology Clinic
🇰🇷Bucheon-si, Gyeonggi-Do, Korea, Republic of
Good Urology Clinic
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Ssen Urology Clinic
🇰🇷Daejeon, Korea, Republic of
Incheon Medical Center
🇰🇷Incheon, Korea, Republic of
Lee and Lee dermatology urology clinic
🇰🇷Incheon, Korea, Republic of
Kim Jun-Ho Urology Clinic
🇰🇷Seoul, Korea, Republic of
Park Byung Dae Urology Clinic
🇰🇷Seoul, Korea, Republic of
Jin Kilnam Urology Clinic
🇰🇷Seoul, Korea, Republic of
Boram St.Mary's Internal Medicine
🇰🇷Seoul, Korea, Republic of
Nowon Paik Urology Clinic
🇰🇷Seoul, Korea, Republic of
Cheonan Medical Center
🇰🇷Cheonan-Si, Chungcheongnam-do, Korea, Republic of
Song In-Ho Urology Clinic
🇰🇷Dangjin-si, Chungcheongnam-Do, Korea, Republic of
Seoul Urology Clinic
🇰🇷Seongnam, Gyeonggi-Do, Korea, Republic of
Park Dermatology And Urology Clinic
🇰🇷Pyeongtaek, Gyeonggi-Do, Korea, Republic of
Good morning Clinic, Pyeongtaek
🇰🇷Pyeongtaek, Gyeonggi-do, Korea, Republic of
Cheong Urology Clinic
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Bes Top Urology Clinic
🇰🇷Seoul, Korea, Republic of
Dongsuwon General Hospital
🇰🇷Suwon-si, Gyeonggi-do, Korea, Republic of
Min Urology Clinic
🇰🇷Uijeongbu-si, Gyeonggi-Do, Korea, Republic of
Choi Won Suk urology clinic
🇰🇷Yongin-si, Gyeonggi-do, Korea, Republic of
Well Urology Clinic
🇰🇷Yongin, Gyeonggi-Do, Korea, Republic of
Kwon Urology Clinic
🇰🇷Daejeon, Korea, Republic of
Hanvit Urology Clinic
🇰🇷Incheon, Korea, Republic of
Dr. Cho & Lee's Urology Clinic
🇰🇷Seoul, Korea, Republic of
Won Urology Clinic
🇰🇷Seoul, Korea, Republic of
Woo Tae Hyung urology clinic
🇰🇷Seoul, Korea, Republic of
Dong Seoul Hospital
🇰🇷Seoul, Korea, Republic of
S-Up Clinic
🇰🇷Seoul, Korea, Republic of
Park Kyu Hong Urology Clinic
🇰🇷Seoul, Korea, Republic of
Seonreung Top Urology Clinic
🇰🇷Seoul, Korea, Republic of
Daehang Hospital
🇰🇷Seoul, Korea, Republic of
Su clinic
🇰🇷Seoul, Korea, Republic of
Urotop Urology Clinic
🇰🇷Seoul, Korea, Republic of
Yoo Jong Keun Urology Clinic
🇰🇷Seoul, Korea, Republic of
Seong Ae Hospital
🇰🇷Seoul, Korea, Republic of
Korea Ace Urology Clinic
🇰🇷Seoul, Korea, Republic of
Woo ri dermatology urology clinic
🇰🇷Seoul, Korea, Republic of
Jung Ho Hyun Urology Clinic
🇰🇷Seoul, Korea, Republic of
Miz-Medi Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan Jeil Hopital
🇰🇷Ulsan, Korea, Republic of
Seoul Top Clinic
🇰🇷Seoul, Korea, Republic of
Haram Urology Clinic
🇰🇷Yongin-si, Gyeonggi-Do, Korea, Republic of
Park Yong Hyun Urology Clinic
🇰🇷Seoul, Korea, Republic of
Saerom urology clinic
🇰🇷Seoul, Korea, Republic of