urinary incontinence, Overactive bladder
Conditions
Interventions
bladder training app and urination prediction device
Sponsors
Save Medical Corporation
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Women between the ages of 20 and 64 at the time consent is obtained 2)Participants whose urinary frequency averaged between 8 and 14 times per 24 hours in the urinary status recorded on the app during the observation period 3)Participants who had urinary urgency or leakage with urinary urgency at least once per 24 hours in the urinary status recorded on the app during the observation period. 4)Participants who can attach DFree and perform bladder training for a certain period 5)Participants who can use online conferencing tools and LINE 6)Participants who have an iPhone supported by iOS13 or higher (iPhone 6s or higher)
Exclusion criteria
Exclusion criteria: 1)Participants who have hematuria 2)Participants who have discomfort or pain associated with urination 3)Participants who have a residual urine 4)Participants who are taking medication for overactive bladder 5)Participants with a history of pelvic surgery or radiation therapy 6)Participants with a history of neurological disease 7)Participants who are using estrogen preparations 8)Participants with the following diseases (diabetes, spina bifida, uterine fibroids, severe constipation, peripheral neuropathy) 9)Pregnant participants 10)Participants who are using implantable medical devices (pacemakers, defibrillators, etc.) 11)Participants whose records of DFree did not reach zero after urinating during the observation period 12)Participants who are considered as inappropriate for this study by the research collaborating physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline (observation period) in average daily frequency of urination at 8 weeks of treatment period | — |
Countries
Japan
Contacts
Public ContactAyako Tamura
Save Medical Corporation Business Development Department
Outcome results
None listed