UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037890 |
|---|---|
| Receipt number | R000043169 |
| 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) |
| Date of disclosure of the study information | 2019/09/02 |
| Last modified on | 2021/04/09 12:30:30 |
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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
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
s-isotani@juntendo.ac.jp
Sponsor or person
Institute
Otsuka Techno Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043169
