Prospective, single-center, randomized, single-blind sham-controlled study of the urinary dysfunction treatment device O-NES in patients with overactive bladder who are unresponsive to or unsuitable for conservative therapy (pilot study)
Not Applicable
- Conditions
- Overactive bladder
- Registration Number
- JPRN-UMIN000037890
- Lead Sponsor
- Otsuka Techno Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 47
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of improvement of the urinary frequency or urinary incontinence
- Secondary Outcome Measures
Name Time Method