Protocol summary

Summary
This interventional study is designed as a clinical trial in the form of a randomized, single blinde, single centered method. Patients are selected from the outpatient refers from Physical Medicine and Rehabilitaion Clinics of Iran University of Medical Sciences . They are allocated by inclusion criteria to 2 groups of 24 for each by random number table. They are informed by the research therapeutic aims and each of them fill the consent form beforehand. Posterior Tibial Nerve Stimulation method is done with a single gauge 34 filliform needle inserted on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12. On the second group this stimulation is done with the same parameters but with the surface pad electrod instead of the needle. Patients are asked to fill the questionnaire with items for urination episodes during wakefulness, sleep, Urgency and urinary incontinence during the last 7 days. The patients are asked to fill the Overactive Bladder Symptom Score (OABSS) form before and after the treatment also weekly during the treatment. They also asked to do the same monthly for the 6 month afterward. Incontinence - Quality Of Life Questionnaire (I- QOL) is also filled before and after the treatment and also 6 month later. Before the initiation of the study patients are asked for Fast Blood Suger (FBS), those which are higher than 100 are excluded from the study. They also do the Urine Culture Test, only negative cases are included.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016101730339N1
Registration date: 2016-12-04, 1395/09/14
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-12-04, 1395/09/14
Registrant information
Name
Esmail Nouri
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8214 1229
Email address
drn94778@gmail.com
Recruitment status
Recruitment complete
Funding source
Governmental - Iran University of Medical Sciences
Expected recruitment start date
2016-10-06, 1395/07/15
Expected recruitment end date
2017-06-21, 1396/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative effect of Percutaneous Tibial Nerve Stimulation versus Transcutaneous Posterior Tibial Nerve Stimulation efficacy in the treatment of Overactive Bladder Syndrome
Public title
Comparative effect of Percutaneous Tibial Nerve Stimulation versus Transcutaneous Posterior Tibial Nerve Stimulation efficacy in the treatment of Overactive Bladder Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion Criteria: Criteria for Overactive Bladder by American Urological Association 2014 Guideline: Each of these Items: Urgency: Sudden feeling of voiding that is irressitable; Frequency: Urination for more than 7 times during wakefulness; Nocturia: Waking for uriantion for more than 1 time; Incontinence: Sudden Involuntary Urine Leakage; Minimun of 18 years for age; Irrisponsiveness to Medical Therapy or Behavioral Change Therapies like Lifestyle Modification and Exercise Therapy; No Usge of Anticholinergic Medications Exclusion Criteria: Diabetes Mellitus; Pregnancy or Intention for that; Urinary Tract Infection or Recurrent Urinary Tract Infection (For more than 4 times a year); Pacemaker Device; Neurological Diseases; Lack of Cooperation or Follow Up
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Commitee of Iran University Of Medical Sciences
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway. Tehran, Iran
City
Tehran
Postal code
1449614535
Approval date
2016-10-02, 1395/07/11
Ethics committee reference number
IR.IUMS.REC1395.9411524008

Health conditions studied

1

Description of health condition studied
Overactive Bladder Syndrome
ICD-10 code
N32.8
ICD-10 code description
Other specified disorders of bladder Incl.: calcified, contracted or overactive Bladder

Primary outcomes

1

Description
Overactive Bladder Symptom
Timepoint
0, 1 and 6 months after treatment
Method of measurement
Overactive Bladder Symtom Score

2

Description
Quality Of Life due to Incontinence
Timepoint
0, 1 and 6 months after treatment
Method of measurement
Incontinence - Quality Of Life Questionnaire Items

Secondary outcomes

empty

Intervention groups

1

Description
On the second group, Posterior Tibial Nerve Stimulation method is done with a surface pad electrod on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12.
Category
Treatment - Devices

2

Description
In the first group, Posterior Tibial Nerve Stimulation method is done with a single gauge 34 filliform needle inserted on the 5 cm to superior side of the medial Malleolus and posterior to tibia. The null electrod is located on the arch of the same foot by the surface Pad.The electrical stimulation is done by the 0.5 to 0.9 mAmp and 20 Hz current by the voltage which can induce plantar flextion on the toe or other toes. Each time stimulation is done for 30 mins for a single session , 3 session a week and total sessions of 12.
Category
Treatment - Devices

Recruitment centers

1

Recruitment center
Name of recruitment center
Firouzgar Hospital
Full name of responsible person
Dr. Esmail Nouri
Street address
Department of Physical Medicine and Rehabilitation, Behafarin St., Karim Khan Zand Ave., Tehran , Iran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Cancellor for Research , Iran University of Medical Sciences
Full name of responsible person
Dr. Javad Ali Musavi
Street address
Iran University of Medical Sciences, Shahid Hemmat Highway, Tehran , Iran
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Cancellor for Research , Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences (IUMS), Faculty of Medicine
Full name of responsible person
Dr.Esmail Nouri
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Behafarin St., Karim Khan Zand Ave., Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
drn94778@gmail.com, pghaboussi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences (IUMS), Faculty of Medicine
Full name of responsible person
Dr.Gholamreza Raissi
Position
Associate Professor
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Behafarin St., Karim Khan Zand Ave., Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
graissi@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences (IUMS), Faculty of Medicine
Full name of responsible person
Dr.Esmail Nouri
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Behafarin St., Karim Khan Zand Ave., Tehran , Iran
City
Tehran
Postal code
Phone
+98 21 8214 1229
Fax
Email
drn94778@gmail.compghaboussi@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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