Protocol summary

Study aim
Comparison of quality of life and clinical results of Trans Tibilal Nerve Stimulation(TTNS) and drug treatment in patients with MS with neurogenic bladder
Design
A randomized clinical trial that is conducted in two groups, the first group receiving physiotherapy treatment and the second group receiving drug treatment, phase 2-3, will be conducted on each group of 27 people, a total of 54 people, and rand function of Excel software was used for randomization.
Settings and conduct
Time :1402 and 1403 in Hashminejad and Firozgar hospitals in Tehran, patients with MS will refer to the urologist with a referral letter from a neurologist based on the diagnosis of MS, and Recently, they have at least one of the symptoms of LUTS such as urgent incontinence, urgency and frequency of daily urination or nocturia, and according to the opinion of the urologist, the symptoms of LUTS need to be investigated and treated, they will be included in the study in two groups of drug treatment and TTNS. They will be assigned to each of the study groups by a simple randomization method using a table of random numbers. In one group, we will do (TTNS) method. A positive electrode is placed 10 cm above the negative electrode along the tibial nerve. The parameter settings include the frequency of 10 Hz and the pulse width of 200 milliseconds. The intensity is 1.5 times the intensity of muscle twitching. Patients will undergo 30-minute outpatient treatment sessions once a week for 12 weeks.
Participants/Inclusion and exclusion criteria
MS disease confirmed by a neurologist, which is proven by the urodynamic test of the patient's overactive bladder, and the patient is over 18 years old.
Intervention groups
TTNS treated group The group under drug treatment with anticholinergics
Main outcome variables
Quality of life include Quality Of Life(QOL) questionnaire and clinical results

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20241010063320N1
Registration date: 2024-11-25, 1403/09/05
Registration timing: registered_while_recruiting

Last update: 2024-11-25, 1403/09/05
Update count: 0
Registration date
2024-11-25, 1403/09/05
Registrant information
Name
Zeinab Ashoori ghazi mahaleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3280 2802
Email address
alirahavi08@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-02, 1403/02/13
Expected recruitment end date
2025-05-03, 1404/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of quality of life and clinical results of posterior tibial nerve stimulation and selective anticholinergic treatment in multiple sclerosis patients with neurogenic bladder in a randomized clinical trial.
Public title
comparison of Effect of TTNS vs anticholinergic in OAB
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Multiple sclerosis confirmed by a neurologist Urodynamic findings based on overactive bladder
Exclusion criteria:
Sacral peripheral nerve lesions UTI Specific prostate size in digital rectal examination Bladder outlet obstruction Pregnancy Diabet melitus type 2 Severe cardio_pulmonary disease History of urinary control surgery Current bladder malignancy
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 54
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be assigned to each of the study groups using a random number table. In this way, at the time of the patient's consultation, the questionnaires, randomly half of them are in the physiotherapy group and the other half of them are in the drug treatment sub-group. The placement of the questionnaire is random and confusing, and the questionnaires and treatment method are all covered with white paper and cannot be distinguished from the content inside at the time of use. Then randomly at the time of visit, an envelope is taken by the doctor, who is unaware of the treatment method, and the method of treatment is determined from it, and the patient also fills the questionnaire inside the same envelope. The patient's name is written on this envelope and the patient fills out the questionnaire again during the next follow-up to check the changes in his condition after the treatment.
Blinding (investigator's opinion)
Double blinded
Blinding description
The method of blinding is that both the doctor and the patient are unaware of the content of the cards at the time of conducting this research. At the beginning of the study, questionnaire envelopes were printed for the total number of participants, which are all the same, then this questionnaire and the name of the treatment method, which is either physiotherapy or drug treatment, are placed inside each envelope containing the questionnaire separately. And all this After closing, the envelopes are randomly placed together and the doctor gives each patient an envelope, so both the doctor and the patient are unaware of the treatment method.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
No 8 mwst rashid gharbi ave, khodami blvd, vanak
City
Tehran
Province
Tehran
Postal code
1994615716
Approval date
2024-02-28, 1402/12/09
Ethics committee reference number
IR.IUMS.FMD.REC.1402.518

Health conditions studied

1

Description of health condition studied
Over active bladder
ICD-10 code
N32.8
ICD-10 code description
Other specified disorders of bladder

Primary outcomes

1

Description
Questionnaire ICIQ_OAB
Timepoint
Comparison between questionnaires in both groups, one at the beginning of treatment and the other 12 weeks after treatment
Method of measurement
Questionnaire ICIQ_OAB & Questionnaire ICIQ_QOL

2

Description
Questionnaire ICIQ_QOL
Timepoint
Comparison between questionnaires in both groups, one at the beginning of treatment and the other 12 weeks after treatment
Method of measurement
Questionnaire ICIQ_QOL

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Treatment with transcutaneous posterior tibial nerve stimulation
Category
Treatment - Devices

2

Description
Intervention group: Treatment with selective anticholinergics
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Hasheminezhad hospital
Full name of responsible person
Zeinab ashoori ghazimahaleh
Street address
Valinezhad ave, vanak
City
Tehran
Province
Tehran
Postal code
1969714713
Phone
+98 21 8116
Email
Hkc.iran2023@gmail.com

2

Recruitment center
Name of recruitment center
Firoozgar hospital
Full name of responsible person
Zeiab ashoori ghazi mahaleh
Street address
Behafarin ave, valiasr
City
Tehran
Province
Tehran
Postal code
1593747811
Phone
+98 21 8214 1201
Email
Firoozgarhospital1@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeinab ashoori ghazi mahaleh
Street address
Hemat Highway next to Milad Tower
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
Info@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeiab ashoori ghazi mahaleh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No 8, west rashid ave , khodami blvd, vanak
City
Tehran
Province
Tehran
Postal code
1994615716
Phone
+98 21 8879 1483
Email
Zeinabashoori1372@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Maryam emami
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Valinezhad ave , hasheminezhad hospital
City
Tehran
Province
Tehran
Postal code
1969414713
Phone
+98 21 8116
Email
Emami59658@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Zeinab ashoori ghazi mahaleh
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Urology
Street address
No 8, rashid gharbi ave , khodami blvd , vanak
City
Tehran
Province
Tehran
Postal code
1994615716
Phone
+98 21 8879 1483
Email
Zeinabashoori1373@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All the data including the initial history and all the questionnaires before and after the treatment can be published
When the data will become available and for how long
Access period starts 6 months after publication
To whom data/document is available
Only for researchers in academic and scientific institutions
Under which criteria data/document could be used
Making citations to articles and scientific and academic uses
From where data/document is obtainable
Responding to requests sent to emails
What processes are involved for a request to access data/document
After the request to zeinabashoori1373@gmail.com email will be answered within a week
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