UMIN-CTR Clinical Trial

Basic information
Public title	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)
Acronym	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)
Scientific Title	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)
Scientific Title:Acronym	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)
Region	Japan

Condition
Condition	Overactive bladder
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate, in an exploratory manner, the safety and efficacy of the urinary dysfunction treatment device O-NES, as well as the suitability of the stimulation condition of the sham stimulation group in patients with overactive bladder symptoms.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Percentage of improvement of the urinary frequency or urinary incontinence
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	In intervention 1, the first 1 week is baseline screening period. The next 2 weeks are the intervention period.
Interventions/Control_2	In intervention 2, the first 1 week is baseline screening period. The next 2 weeks are the intervention period.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key 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).
Key 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.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Shuji Middle name Last name Isotani
Organization	Juntendo University Hospital
Division name	Department of Urology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
TEL	03-5802-1227
Email	s-isotani@juntendo.ac.jp

Public contact
Name of contact person	1st name Shuji Middle name Last name Isotani
Organization	Juntendo University Hospital
Division name	Department of Urology
Zip code	113-8431
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
TEL	03-5802-1227
Homepage URL
Email	s-isotani@juntendo.ac.jp

Sponsor
Institute	Otsuka Techno Corporation
Institute
Department

Funding Source
Organization	Japan Agency for Medical Reseach and Development
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Juntendo University Hospital
Address	3-1-3 Hongo, Bunkyo-ku, Tokyo 113-8431
Tel	03-5802-1584
Email	chiken@juntendo.ac.jp

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2019 Year 09 Month 02 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled	47
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Completed
Date of protocol fixation	2019 Year 08 Month 21 Day
Date of IRB	2019 Year 09 Month 27 Day
Anticipated trial start date	2019 Year 10 Month 29 Day
Last follow-up date	2020 Year 09 Month 10 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 09 Month 02 Day
Last modified on	2021 Year 04 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043169