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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Open public recruiting |
Unique ID issued by UMIN | UMIN000011947 |
Receipt No. | R000013953 |
Scientific Title | Development of the home enforceable percutaneous tibial neuromodulation therapy for the refractory overactivity bladder |
Date of disclosure of the study information | 2013/10/03 |
Last modified on | 2018/10/09 |
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 |
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Condition | ||
Condition | Overactive Bladder | |
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 20 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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 |
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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 | |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |