UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020524 |
|---|---|
| Receipt number | 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 19:07:14 |
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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
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
ymatsuda@u-fukui.ac.jp
Sponsor or person
Institute
Department of Urology, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023696
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