Overactive bladder
Conditions
Interventions
In intervention 1, the first 1 week is baseline screening period. The next 2 weeks are the intervention period.
In intervention 2, the first 1 week is baseline screening period. The next 2 weeks are
Sponsors
Otsuka Techno Corporation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.They are aged 20 years or older at the time they give their informed consent. 2.They have been diagnosed as having symptoms# of an overactive bladder and meet either of the following criteria regarding a history of treatment with anticholinergic drugs or beta 3 receptor agonists: (1) Their symptoms are persisting even though they have received one of these drugs for 12 weeks or longer. (2) They cannot use these drugs due to certain reasons such as side effects and contraindications. # Urinary urgency is essential. In general, symptoms include urinary frequency and nocturia. 3.Their mean urinary frequency is 8 times or more per day and/or they experience urinary incontinence associated with urinary urgency at least twice in 72 hours, as reported in the urinary diary recorded in the baseline screening period (record of at least 3 straight days).
Exclusion criteria
Exclusion criteria: 1.They have any implantable electronic device (e.g. pacemaker). 2.They have received electrical or magnetic stimulation therapy for an overactive bladder in the past. 3.They have a history of treatment with botulinum toxin for the bladder. 4.They have been diagnosed with severe stress urinary incontinence. 5.They have functional urinary incontinence. 6.They have infection or calculus of the lower urinary tract. 7.They have organic urinary tract obstruction. 8.They have been diagnosed with interstitial cystitis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of improvement of the urinary frequency or urinary incontinence | — |
Countries
Japan
Contacts
Public ContactShuji Isotani
Juntendo University Hospital Department of Urology
Outcome results
None listed