UMIN-CTR Clinical Trial

Public title

A clinical trial of SSP electrodes and transcutaneous electrical tibial nerve stimulation for refractory overactive bladder

Acronym

A clinical trial of SSP electrodes and transcutaneous electrical tibial nerve stimulation for refractory overactive bladder

Scientific Title

A clinical trial of SSP electrodes and transcutaneous electrical tibial nerve stimulation for refractory overactive bladder

Scientific Title:Acronym

A clinical trial of SSP electrodes and transcutaneous electrical tibial nerve stimulation for refractory overactive bladder

Region

Japan

Condition

Overactive Bladder

Classification by specialty

Urology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Assessment of efficacy and safety of unilateral tibial nerve stimulation using transcutaneous SSP electrodes on the refractory overactive bladder symptoms, voiding diary and urodynamic parameters

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Developmental phase

Phase I,II

Primary outcomes

Improvements in following questionnaires will be assessed every 4 weeks;
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 before and at the end of the clinical trial;
1) Frequency-volume chart
1. voiding frequency (daytime/nighttime), voiding volume per micturion, nocturnal polyuria index (NPi)

2) Urodynamic study parameters
1. uroflowmetry parameters, post-void residulal volume
2. cystometric parameters

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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 transcutaneous SSP electrodes put on the unilateral medial malleolus. An electrical stimulation is performed once a week consecutively for 12 weeks. If participant asks to continue the clinical trial, treatment will be extended until 52 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

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

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

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

Institute

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

Institute

Department

Personal name

Organization

none

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

01

Month

11

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Open public recruiting

Date of protocol fixation

2015

Year

11

Month

30

Day

Date of IRB

Anticipated trial start date

2016

Year

01

Month

25

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related 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=R000023694