overactive bladder
Conditions
Interventions
Patients who meet all eligibility criteria will be treated with vibegron.
Sponsors
Furuta Akira
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: At the time of consent: - Patients with written consent - Outpatients aged 20 years or older at the date of consent - Patients who can put on and take off wearable devices, charge them, and operate synchronization with smartphones - Patients with an OABSS Q2 score at least 2 and a Q3 score at least 2 At Visit 1 (Week 0): - Patients with an OABSS Q3 score at least 2 and a total score at least 3 - Patients with an average night-time frequency of two or more, as recorded in a bladder diary - Patients who could properly complete a sleep and bladder diary
Exclusion criteria
Exclusion criteria: At the time of consent: - Patients with neurogenic bladder (as determined by the treating physician) - Patients with a history of benign prostatic hyperplasia or pelvic organ prolapse surgery within half a year - Patients with urinary retention - Patients with prolonged catheterization or self-catheterization - Patients with complications that present with symptoms similar to OAB (diabetes insipidus, urinary stone, urinary tract infection, interstitial cystitis, prostatitis) that, at the discretion of the principal investigator or subinvestigators, may affect the evaluation of this study - Patients with a history of injury, surgery, or neurodegenerative diseases (e.g., multiple sclerosis) affecting the lower urinary tract and its innervation - Patients with bladder or prostate cancer, under treatment or planned treatment - Patients with prior hypersensitivity to vibegron - Patients with serious cardiac disease or severe hepatic dysfunction - Patients who are unable to comply with study settings for prohibited concomitant drugs or therapies during the specified period - Patients who started taking or changed the dosage of restricted concomitant drugs during the specified period - Patients with sleep disorders (e.g., sleep apnea syndrome) or those suspected of having sleep disorders, who are not yet treated or have been treated for less than one month - Patients with ignificantly irregular lifestyles, such as those with circadian rhythm sleep disorders or shift workers - Patients using cardiac implantable electronic devices, such as pacemakers or implantable cardioverter defibrillators - Patients who are judged by the principal investigator or subinvestigator to be inappropriate to participate in this study (e.g., patients diagnosed with dementia) At Visit 1 (Week 0): - Patients with post-void residual urine volume greater than or equal to 100 mL - Patients with polyuria (daily urine volume averaging more than 3000 mL per day) - Patients who are unable to comply with study settings for prohibited concomitant drugs or therapies during the specified period - Patients who started taking or changed the dosage of restricted concomitant drugs during the specified period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in night-time frequency, from baseline (0 week) in night-time frequency at 12weeks of treatment with vibegron | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Change in the following items from the baseline (week 0) to 12 weeks after treatment with vibegron - OABSS total score and OABSS subscores - Urinary parameters (average daily urinary frequency, urinary incontinence episodes, night-time frequency, average voided volume, hours of undisturbed sleep, average daily total urine volume/nocturnal urine volume) in bladder diary - Subjective sleep quality (total AIS score, total N-QOL score and each scores by category) - Objective sleep quality (based on data collected from the wearable device and calculated from sleep and bladder diary, including sleep onset latency, number of awakenings, wake after sleep onset, sleep efficiency, and other related parameters) - Other parameters that can be obtained from wearable devices (including indicators of activity during the day) 2) PGI evaluation at 12 weeks will be performed and the distribution (number and percentage) will be presented by descriptive statistics. In addition, satisfaction is classified into 3 categories and presented as improvement rate. | — |
Contacts
Public ContactAkira Furuta
Tsunan Hospital
Outcome results
None listed