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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000020524
Receipt No. R000023696
Scientific Title A clinical trial of home-based transcutaneous tibial neuromodulation therapy for refractory overactive bladder: a combination therapy with tramadol
Date of disclosure of the study information 2016/01/11
Last modified on 2016/01/18

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Basic information
Public title A clinical trial of home-based transcutaneous tibial neuromodulation therapy for refractory overactive bladder: a combination therapy with tramadol
Acronym A combination therapy of transcutaneous tibial neuromodulation with tramadol for refractory overactive bladder
Scientific Title A clinical trial of home-based transcutaneous tibial neuromodulation therapy for refractory overactive bladder: a combination therapy with tramadol
Scientific Title:Acronym A combination therapy of transcutaneous tibial neuromodulation with tramadol for refractory overactive 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 transcutaneous tibial nerve stimulation combinated with tramadol administration on the refractory overactive bladder symptoms, voiding diary and urodynamic parameters
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Improvements in following questionnaires will be assessed at 12- and 24-week;
1. International Prostate Symptom Score and QOL index
2. Overactive Bladder Symptom Score
3. International Index of Erectile Dysfunction in male subjects/Female Sexual Function Index in female subjects
4. King's Health Questionnaire, Japanese edition
Key secondary outcomes Assessment of following examinations will be carried out at 12- and 24-week;
1) Frequency-volume chart
1. voiding frequency, voiding volume, nocturnal polyuria index (NPi)

2) Urodynamic study parameters
1. Uroflowmetry parameters, post-void residulal volume
2. Cystometric parameters

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 A washout period of 2 weeks will be scheduled before the clinical trial. Participants take tramadol (25-100 mg/ day bid, depending on adverse event) for 24 weeks. A 5 Hz frequency, 0.05 ms pulse width, biphasic electric stimulation is applied via surface electrodes put on unilateral sole/medial malleolus or St.36. Participant stimulates unilateral foot or St.36 once a day consecutively for 12 weeks. Treatment efficacy will be assessed after the first 12-week-stimulation. Then, the participant changes the stimulation locus and continues stimulation for another 12 weeks. Treatment efficacy at 12 or 24 weeks will be compared with pre-treatment data.
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 who are 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 comorbidities
3. Able to understand the nature of study and give written informed consent
4. 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 metallic implants inside the stimulation locus
3. Patients with severe heart or lung 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 stimulation locus
6. Pregnant women
7. Patients with history of convulsion or patients seizures are predicted
8. Patients with excessive post-void residual volume (100 ml or 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 40

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 15th Asahi Kasei pharma Urological Academy research grant
Organization
Division
Category of Funding Organization Profit organization
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 11 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
2015 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 02 Month 01 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
2016 Year 01 Month 11 Day
Last modified on
2016 Year 01 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023696

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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