The objective of this study is to determine the problems and questions of safety and efficacy of Toviaz® under the standard conditions of usage.
continuous registration method
Study Type
OBSERVATIONAL
Enrollment
3,000
4 mg starting then can be followed by 8 mg
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
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.
Time frame: From the time that the participant signed data privacy statement through and including 28 calendar days after the last administration of the study drug.
Investigator's Final Assessment of Effectiveness 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).
Time frame: At the end of study treatment
Change From Baseline in Number of Micturitions Per 24 Hours 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.
Time frame: Baseline and at the end of study treatment
Change From Baseline in Number of Urgency Episodes Per 24 Hours 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.
Time frame: Baseline and at the end of study treatment
Change From Baseline in Number of UUI Episodes Per 24 Hours 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.
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Soo Urology Clinic
Asan, Chungcheongnam-do, South Korea
Seo Kyung-Keun Urology Clinic
Cheonan-si, Chungcheongnam-do, South Korea
Cheonan Medical Center
Cheonan-Si, Chungcheongnam-do, South Korea
Seoul Urology Clinic
Gongju, Chungcheongnam-do, South Korea
Lee Urology Clinic
Gongju, Chungcheongnam-do, South Korea
Moa gynecology
Nonsan, Chungcheongnam-do, South Korea
Song In-Ho Urology Clinic
Tangjin, Chungcheongnam-do, South Korea
Jung Woong Gyo Urology Clinic
Wŏnju, Gangwon-do, South Korea
Ansan Themapark Medical Center
Ansan, Gyeonggi-do, South Korea
Woosung Yusung Hospital
Ansan, Gyeonggi-do, South Korea
...and 72 more locations
Time frame: Baseline and at the end of study treatment
Participant Perception of Bladder Condition 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.
Time frame: Baseline and at the end of study treatment
Percentage of Participants With a Final Efficacy Assessment of Effective by Baseline and Treatment Characteristics
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) .
Time frame: At the end of study treatment