UMIN-CTR Clinical Trial

Basic information
Public title	Development of the home enforceable percutaneous tibial neuromodulation therapy for the refractory overactivity bladder
Acronym	Development of the home enforceable neuromodulation therapy for the refractory overactivity bladder
Scientific Title	Development of the home enforceable percutaneous tibial neuromodulation therapy for the refractory overactivity bladder
Scientific Title:Acronym	Development of the home enforceable neuromodulation therapy for the refractory overactivity bladder
Region	Japan

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

Objectives
Narrative objectives1	Assessment of efficacy and safety of daily unilateral tibial nerve stimulation by portable transcutaneous electric modulator on the refractory overactive bladder symptoms, by voiding diary or urodynamic parameters
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Assess the improvement in the following questionnaire 1. International Prostate Symptom Score and QOL index 2. Overactive Bladder Symptom Score 3. Core lower urinary tract symptom score 4. King's Health Questionnaire, Japanese edition 2) Assess the improvement in the frequency-volume chart voiding frequency, voiding volume, nocturnal polyuria index (NPi) 3) Assess the improvement in the urodynamic study parameters 1. uroflowmetry parameters, post-void residual volume 2. cystometric parameters
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	A 5 Hz frequency, 0.2 ms pulse width, biphasic electric stimulation is applied via surface electrodes put on the unilateral sole or internal malleolus. An 30-minute-stimulation is given once a day consecutively for 12 weeks.
Interventions/Control_2
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. Patients with overactive bladder resistant to the standard therapies (behavior therapy, antimuscarinics, beta3 receptor agonist, etc.) 2. Patients with overactive bladder having difficulty with continuation of medical therapy because of side effects or co-morbidities 3. Patients who are able to understand the nature of study and give written informed consent 4. Patients who have willingness and ability to comply with the study protocol for the duration of the study
Key exclusion criteria	1. Patients with cardiac pacemakers 2. Patients with severe arrhythmia (AV block, etc.) 3. Patients with severe heart disease 4. Patients with venous/arterial thrombosis or thrombophlebitis of lower extremities 5. Patients with skin disorder (injury, scar, skin disease, malignancy, etc.) on the lower extremities 6. Pregnant women 7. Patients with history of convulsion or patients seizures are predicted 8. Patients with excessive post-void residual volume (100 ml and more) 9. Patients with bladder disorders (calculus, cancer, tuberculosis, chronic bacterial cystitis, radiation cystitis, etc.) 10. Any condition which in the judgment of the investigator would place the patient inappropriate to be enrolled in this study
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Osamu Yokoyama
Organization	University of Fukui
Division name	Department of Urology
Zip code
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL	0776-61-8399
Email	oyoko@u-fukui.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yosuke Matsuta
Organization	University of Fukui
Division name	Department of Urology
Zip code
Address	23-3 Matsuokashimoaizuki, Eiheiji-cho, Yoshida-gun, Fukui 910-1193, Japan
TEL	0776-61-8399
Homepage URL
Email	ymatsuda@u-fukui.ac.jp

Sponsor
Institute	Department of Urology, Faculty of Medical Sciences, University of Fukui
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	福井大学医学部附属病院

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 03 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
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	Open public recruiting
Date of protocol fixation	2013 Year 06 Month 13 Day
Date of IRB
Anticipated trial start date	2013 Year 10 Month 03 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 10 Month 03 Day
Last modified on	2018 Year 10 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013953

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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