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Effect of percutaneous posterior tibial nerve stimulation on treatment of lower urinary tract symptom in women patient multiple sclerosis who referred to Emam Khomeini hospital

Protocol summary

Summary
In the intervention study, twenty women patients (between 18-55 years old) with various kinds of multiple sclerosis (MC Donald 2010 criteria) and have urinary symptom with detrusor sphincter dyssynergia or over active bladder refractory to drug therapy are considered in study. The exclusion criteria are urinary infection, pervious urogenital surgery, renal stone, pregnancy, severe cardiopulmonary diseases, physical inability, diabetes mellitus, other central nervous system diseases. Also, patients who don’t consent do not consider. When the urinary symptoms aggravate, attack of multiple sclerosis appear or weekly treatment are not followed, are removed from the study. Patients will be treated with 12 sections of electrical posterior tibial stimulation. Each stimulation will be applied for 30 minutes, once a week for 12 weeks, by unilateral insertion of 38 monopolar needle at 60-degree angle, approximately 5cm cephalad to the medial malleolus and slightly posterior to the tibial. Stimulation will be done with .5-9mA current level , 200 microsec pulse and pulse rate of 20 Hz, based on base subjects foot planter motor and sensory response . PVR and UDS will be performed after 12 weeks. The effect of stimulation on urodynamic and PVR will be compared of paseline and after stimulation.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013031512820N1
Registration date: 2013-04-17, 1392/01/28
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2013-04-17, 1392/01/28
Registrant information
Name
Payam Sarraf
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2424
Email address
p-sarraf@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-08-06, 1392/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of percutaneous posterior tibial nerve stimulation on treatment of lower urinary tract symptom in women patient multiple sclerosis who referred to Emam Khomeini hospital
Public title
the effect of tibial nerve stimulation on urinary symptoms in multiple sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Women with Multiple Sclerosis (between 18-55 years old) who have lower urinary symptoms such as urgency, frequency and nacturia with detrusor sphincter dyssynergia or over active bladder refractory to drug therapy (treatment of at least three months with one or two anticholinergic drugs) are included in study. The exclusion criteria are: urinary infection; previous urogenital surgery; renal stone; pregnancy; severe cardiopulmonary diseases; physical inability; diabetes mellitus; other central nervous system diseases. Also, patients who don’t consent do not consider. When the urinary symptoms aggravate, attack of multiple sclerosis appear or weekly treatment are not followed, the patients are also removed from the study.
Age
From 18 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences Ethics Committee
Street address
Tehran University of Medical Sciences
City
Tehran
Postal code
Approval date
2013-03-09, 1391/12/19
Ethics committee reference number
78777-20284-054-04-91

Health conditions studied

1

Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis

Primary outcomes

1

Description
Maximum-systometric-capacity
Timepoint
Before and after intervention
Method of measurement
Urodynamic study

2

Description
Involuntary detrusor contraction volume
Timepoint
Before and after intervention
Method of measurement
Urodynamic study

Secondary outcomes

1

Description
Frequency
Timepoint
In each refering
Method of measurement
Ask from the patients

2

Description
Nacturia
Timepoint
In each refering
Method of measurement
Ask from the patients

3

Description
PVR
Timepoint
Before and after of stimulation
Method of measurement
Nelaton Catheter

Intervention groups

1

Description
Patients will be treated with 12 sections of electrical posterior tibial stimulation. Each stimulation will be applied for 30 minutes, once a week for 12 weeks, by unilateral insertion of 38 monopolar needle at 60-degree angle, approximately 5cm cephalad to the medial malleolus and slightly posterior to the tibial. Stimulation will be done with .5-9mA current level , 200 microsec pulse and pulse rate of 20 Hz, based on base subjects foot planter motor and sensory response .The age, kind of disease , the average duration of disease, duration of urinary symptom , EDSS, frequency nacturia, PVR and UDS will be recorded. PVR and UDS will be performed after 12 weeks. The effect of stimulation on urodynamic and PVR will be compared of paseline and after stimulation.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam khomeini hospital-Iranian Center of Neurological Research
Full name of responsible person
Street address
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for research, Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbar Fotouhi
Street address
tehran-ghods ave. -central organization of Tehran university of medical sciences-six floor
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Sarraf Payam
Position
Assisstant professor
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
p-sarraf@tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sarraf Payam
Position
Assistant professor
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
+98 21 6119 2424
Fax
Email
p-sarraf@tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sarraf Payam
Position
Assisstant professor
Other areas of specialty/work
Street address
Imam khomeini hospital
City
Tehran
Postal code
Phone
Fax
Email
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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