Comprasion of efficacy of Drug therapy(Solifenacin Succinate) and physiotherapy(Stimulation of Posterior Tibialis Nerve) on treatment of overactive Bladder and quality of life in Patients with Multiple Sclerosis
Comprasion of efficacy of Drug therapy and Physiotherapy on treatment of overactive Bladder and quality of life in Patients with Multiple Sclerosis
Design
Clinical trial with two parallel groups, Single blind, Randomized, Phase 2 and performed on 75 Patients. Randomization using software and random block method in which two patients are randomly assigned in each block and generated A random sequence of code will occur
Settings and conduct
Ahvaz MS center
Participants/Inclusion and exclusion criteria
Inclusion criteria are:
Have a minimum score of 3 in the actionable questionnaire to confirm neurogenic overactive Bladder
No infection in the Urinary tract
At least 1 month has passed since the onset of symptoms of overactive bladder disorder
EDSS scale (severity of degree of disability) 1 to 5.5
Exclusion criteria are:
Pregnant women and those who want to get pregnant within the next year
Heart problems (such as Heart failure, etc.)
Having diabetes and neurological diseases such as Parkinson's
History of Electrotherapy treatment in the lower Limbs and lower Back and history of Pelvic floor Muscle Physiotherapy during a recent month
Having a Heart pacemaker and a Prosthesis in the Leg
Intervention groups
All patients will continue their treatment regimen as before and for patients in the first group of sulifenacin drug therapy is first prescribed at a dose of 5 mg daily for 4 weeks and then increase the dose if the patient tolerates to 10 mg per day (5 mg). Twice a day) and lasts up to 8 to 12 weeks. For patients in the second group, physiotherapy will be performed by posterior tibialis nerve stimulation. The number of posterior tibial nerve stimulation sessions is 12 sessions in 12 weeks (one session per week) and duration. Each session will be 30 minutes.
Main outcome variables
Severity of urinary incontinence, urinary incontinence score, quality of life
General information
Reason for update
Acronym
Ms
IRCT registration information
IRCT registration number:IRCT20210207050277N1
Registration date:2021-03-13, 1399/12/23
Registration timing:prospective
Last update:2021-03-13, 1399/12/23
Update count:0
Registration date
2021-03-13, 1399/12/23
Registrant information
Name
Mohammad Jafari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3374 3012
Email address
jafari.mo@ajums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-03-21, 1400/01/01
Expected recruitment end date
2021-07-22, 1400/04/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comprasion of efficacy of Drug therapy(Solifenacin Succinate) and physiotherapy(Stimulation of Posterior Tibialis Nerve) on treatment of overactive Bladder and quality of life in Patients with Multiple Sclerosis
Public title
The effect of Drug therapy on the treatment of overactive Bladder in Multiple Sclerosis, The effect of Physiotherapy on the treatment of overactive Bladder in Multiple Sclerosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
No infection in the Urinary tract
Have a minimum score of 3 in the Actionable questionnaire to confirm Neurogenic overactive Bladder
Urinary incontinence that may or may not be accompanied by urgent Urinary incontinence
At least 1 month has passed since the onset of symptoms of overactiveBladder disorder
At least one month has passed since the last MS attack
EDSS scale (severity of degree of disability) 1 to 5.5
Exclusion criteria:
Pregnant Women and those who want to get Pregnant within the next year
Allergy to the Drug Sulifenacin such as Angioedema
Heart problems (such as Heart failure)
Have a history of surgery to treat Urinary incontinence or other Urinary tract surgeries
Having stress Urinary incontinence
Having Diabetes and Neurological diseases such as Parkinson's
History of Anticholinergic Drug therapy for the treatment of overactive Bladder during the last month
History of Electrotherapy treatment in the lower limbs and lower back and history of Pelvic floor Muscle Physiotherapy during a recent month
Having a Heart Pacemaker and a Prosthesis in the leg
Having a lesion at the site of Electrical stimulation of the Posterior Tibial Nerve
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
Investigator
Data analyser
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
Using the random block method, both people are randomly assigned to one of the two groups with the help of random codes generated. The size of the blocks is considered to be equal to 2, and inside each block, two random codes, one for group one and the other for group 2, are generated randomly. This is done with the help of random allocation
https://www.sealedenvelope.com
done.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this single blind study, Participants and Outcome assessors are aware of the type of study, but Researchers and Data analyzer are not aware of the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Ahwaz Jundishapur University of Medical Sciences
Street address
Department of Neurology, Golestan Hospital, Farvardin Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Approval date
2020-12-22, 1399/10/02
Ethics committee reference number
IR.AJUMS.HGOLESTAN.REC.1399.127
Health conditions studied
1
Description of health condition studied
Multiple sclerosis
ICD-10 code
G35
ICD-10 code description
Multiple sclerosis
2
Description of health condition studied
Overactive Bladder Disorder
ICD-10 code
N32
ICD-10 code description
Other disorders of bladder
Primary outcomes
1
Description
Severity of Urinary Symptoms
Timepoint
Evaluation of urinary symptoms at the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention
Method of measurement
International Consultation on Incontinence Questionnaire Overactive Bladder (ICIQ-OAB)
2
Description
Urinary Incontinence
Timepoint
Evaluation of urinary incontinence at the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention
Method of measurement
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form(ICIQ-UI SF)
Secondary outcomes
1
Description
Quality Of Life
Timepoint
Evaluation of Quality of life at the beginning of the study (before the intervention) and 4, 8 and 12 weeks after the intervention
Method of measurement
Multiple Sclerosis Quality of Life Questionnaire (MSQOL-54)
Intervention groups
1
Description
First Intervention group: Drug treatment The oral tablet of Sulifenacin succinate 5 mg under the brand name Vsol (Abidi Company) is used. It was developed in 2004 and is one of the antimuscarinic drugs that works by reducing bladder contractions. It is initially given at a dose of 5 mg daily for 4 weeks. Then increase the dose to 10 mg per day (5 mg twice daily) if the patient tolerates and lasts for 8 to 12 weeks.
Category
Treatment - Drugs
2
Description
Second Intervention group: Electrical stimulation of the posterior tibial nerve using a dual-channel x733 stimulator device with a model of 1396 and made in Iran will be applied. The current characteristics used will be as follows: intensity 0.5 to 10 mA, frequency 20 Hz, pulse length 200 microseconds.However, the intensity of the stimulation will increase to the threshold of motor nerve stimulation, which is characterized by flexion of the first toe. So far, no side effects have been reported on superficial electrical stimulation of the posterior tibial nerve. For electrical stimulation, the negative electrode (cathode) is placed behind the inner ankle and the positive electrode (anode) is 10 cm above the cathode. The number of posterior tibial nerve stimulation sessions will be 12 sessions in 12 weeks (one session per week) and the duration of each session will be 30 minutes.
شهر دانشگاهی، معاونت تحقیقات و فناوری دانشگاه علوم پزشکی و خدمات بهداشتی درمانی جندی شاپور اهواز
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3333 3477
Email
research@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
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
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3377 3012
Email
dr.mohammadjafari1368@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Neurology Resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3377 3012
Email
dr.mohammadjafari1368@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Jafari
Position
Neurology resident
Latest degree
Medical doctor
Other areas of specialty/work
Neurology
Street address
Department of Neurology, Golestan Hospital, Farvardin Street, Golestan
City
Ahvaz
Province
Khouzestan
Postal code
61357-15794
Phone
+98 61 3377 3012
Email
dr.mohammadjafari1368@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
Yes - There is 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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
After defending the dissertation and approval by Ahwaz University of Medical Sciences, the collected data (after identifying the participants) will be fully available to researchers and patients.
When the data will become available and for how long
Access period starts six months after the results are published
To whom data/document is available
If requested, the results will be available to other researchers working in academic and scientific institutions.
Under which criteria data/document could be used
The information of this trial will be provided to researchers and patients with the aim of improving the quality of life of patients with multiple sclerosis.
From where data/document is obtainable
Receiving documents will be possible by sending an email to the person in charge of the update.
What processes are involved for a request to access data/document