Efficacy of the percutaneous tibial nerve stimulation in the treatment of OABS (Over Active Bladder Syndrome ) in both technique :unilateral and bilateral nerve stimulating
Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
Protocol summary
Using the online site sealedenvelop.com (the site for sequencing block randomization) The four blocks are randomly assigned to patients in two groups: A: The patient receives only one electrode, and B: The patient receives both electrodes (standard treatment).
The order in which the patients are placed to receive the electrode is provided to the technician.
The study is Double blind. (Patient and surgeon)
72 patients referred to Sinai Hospital (with ethical consent) are studied.
The study is an intervention, phase 3, parallel and therapeutic.
Using the online site sealedenvelop.com (the site for sequencing block randomization) The four blocks are randomly assigned to patients in two groups: A: The patient receives only one electrode, and B: The patient receives both electrodes (standard treatment).
The order in which the patients are placed to receive the electrode is provided to the technician.
The study is Double blind. (Patient and surgeon)
32 patients referred to Sinai Hospital (with ethical consent) are studied.
The study is an intervention, phase 3, parallel and therapeutic.
Using the online site sealedenvelop.com (the site for sequencing block randomization) The four blocks are randomly assigned to patients in two groups: A: The patient receives only one electrode, and B: The patient receives both electrodes (standard treatment). The order in which the patients are placed to receive the electrode is provided to the technician. The study is Double blind. (Patient and surgeon) 7232 patients referred to Sinai Hospital (with ethical consent) are studied. The study is an intervention, phase 3, parallel and therapeutic.
با استفاده از سایت آنلاین sealedenvelop.com ( سایت جهت تهیه توالی بلاک رندومیزیشین) بلوک های چهارتایی بصورت تصادفی بیماران در دو گروه A : بیمار تنها یک الکترود میگیرد و B : بیمار هر دو الکترود را دریافت می کنند(درمان استاندارد).
ترتیب قرار گیری بیماران جهت دریافت الکترود، در اختیار تکنسین قرار میگیرد.
مطالعه دو سویه کور می باشد. (بیمار و جراح)
۷۲ بیمار مراجعه کننده به بیمارستان سینا مورد مطالعه قرار میگیرند.
مطالعه بصورت مداخله ای، فاز ۳، موازی و درمانی می باشد.
با استفاده از سایت آنلاین sealedenvelop.com ( سایت جهت تهیه توالی بلاک رندومیزیشین) بلوک های چهارتایی بصورت تصادفی بیماران در دو گروه A : بیمار تنها یک الکترود میگیرد و B : بیمار هر دو الکترود را دریافت می کنند(درمان استاندارد).
ترتیب قرار گیری بیماران جهت دریافت الکترود، در اختیار تکنسین قرار میگیرد.
مطالعه دو سویه کور می باشد. (بیمار و جراح)
32 بیمار مراجعه کننده به بیمارستان سینا مورد مطالعه قرار میگیرند.
مطالعه بصورت مداخله ای، فاز ۳، موازی و درمانی می باشد.
با استفاده از سایت آنلاین sealedenvelop.com ( سایت جهت تهیه توالی بلاک رندومیزیشین) بلوک های چهارتایی بصورت تصادفی بیماران در دو گروه A : بیمار تنها یک الکترود میگیرد و B : بیمار هر دو الکترود را دریافت می کنند(درمان استاندارد). ترتیب قرار گیری بیماران جهت دریافت الکترود، در اختیار تکنسین قرار میگیرد. مطالعه دو سویه کور می باشد. (بیمار و جراح) ۷۲32 بیمار مراجعه کننده به بیمارستان سینا مورد مطالعه قرار میگیرند. مطالعه بصورت مداخله ای، فاز ۳، موازی و درمانی می باشد.
This clinical trial will be performed on 72 patients at Sina Hospital.
Double blind(Patient and surgeon)
Technician (importer of patients in each group based on random blocks)
Random blocks, four blocks randomly from patients
A: an electrode
B: two electrodes
18 quadruple blocks are made which are placed in separate envelopes.
Randomized blocks are given to a technician.
After the patient enters, the technician performs the intervention by opening each envelope regarding the intervention method (A or B) for the patient.
This clinical trial will be performed on 32 patients at Sina Hospital.
Double blind(Patient and surgeon)
Technician (importer of patients in each group based on random blocks)
Random blocks, four blocks randomly from patients
A: an electrode
B: two electrodes
8 quadruple blocks are made which are placed in separate envelopes.
Randomized blocks are given to a technician.
After the patient enters, the technician performs the intervention by opening each envelope regarding the intervention method (A or B) for the patient.
This clinical trial will be performed on 7232 patients at Sina Hospital. Double blind(Patient and surgeon) Technician (importer of patients in each group based on random blocks) Random blocks, four blocks randomly from patients A: an electrode B: two electrodes 188 quadruple blocks are made which are placed in separate envelopes. Randomized blocks are given to a technician. After the patient enters, the technician performs the intervention by opening each envelope regarding the intervention method (A or B) for the patient.
این کارآزمایی بالینی در بیمارستان سینا بر روی 72 بیمار انجام خواهد شد.
دو سویه کور (بیمار و جراح)، تکنسین (وارد کننده بیمارن در هر گروه بر اساس بلوک های تصادفی)
بلوک تصادفی، بلوک های چهارتایی بصورت تصادفی بیماران
بیماران گروه A : یک الکترود
بیماران گروه B : دو الکترود
18 بلوک چهارتایی ساخته می شود که در پاکت های جداگانه قرار داده می شود. بلوک های تصادفی سازی شده در اختیار یک تکنسین قرار میگیرند. تکنسین پس از ورود بیمار، با باز کردن هر پاکت در خصوص روش مداخله (A یا B) برای بیمار مداخله را اجرا می کند.
این کارآزمایی بالینی در بیمارستان سینا بر روی 32 بیمار انجام خواهد شد.
دو سویه کور (بیمار و جراح)، تکنسین (وارد کننده بیمارن در هر گروه بر اساس بلوک های تصادفی)
بلوک تصادفی، بلوک های چهارتایی بصورت تصادفی بیماران
بیماران گروه A : یک الکترود
بیماران گروه B : دو الکترود
8 بلوک چهارتایی ساخته می شود که در پاکت های جداگانه قرار داده می شود. بلوک های تصادفی سازی شده در اختیار یک تکنسین قرار میگیرند. تکنسین پس از ورود بیمار، با باز کردن هر پاکت در خصوص روش مداخله (A یا B) برای بیمار مداخله را اجرا می کند.
این کارآزمایی بالینی در بیمارستان سینا بر روی 7232 بیمار انجام خواهد شد. دو سویه کور (بیمار و جراح)، تکنسین (وارد کننده بیمارن در هر گروه بر اساس بلوک های تصادفی) بلوک تصادفی، بلوک های چهارتایی بصورت تصادفی بیماران بیماران گروه A : یک الکترود بیماران گروه B : دو الکترود 188 بلوک چهارتایی ساخته می شود که در پاکت های جداگانه قرار داده می شود. بلوک های تصادفی سازی شده در اختیار یک تکنسین قرار میگیرند. تکنسین پس از ورود بیمار، با باز کردن هر پاکت در خصوص روش مداخله (A یا B) برای بیمار مداخله را اجرا می کند.
General information
72
32
7232
empty
Due to the low number of resistant PTNS patient samples, the number of samples was reduced to 32, 16 in each group.
Due to the low number of resistant PTNS patient samples, the number of samples was reduced to 32, 16 in each group.
empty
با توجه به اینکه تعداد نمونه های بیمار PTNS مقاوم به درمان کم می باشد تعداد نمونه ها به 32 نفر، 16 نفر در هر گروه کاهش یافت.
با توجه به اینکه تعداد نمونه های بیمار PTNS مقاوم به درمان کم می باشد تعداد نمونه ها به 32 نفر، 16 نفر در هر گروه کاهش یافت.
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraian
Full name of responsible person - Persian: دکتر محمد علی صحرائیان
Street address - English: Tehran. Keshavarz Boulevard, Quds Ave., Central University, Sixth Floor
Street address - Persian: تهران.بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3685
Fax: +98 21 8163 3686
Email: vcr@tums.ac.ir
Web page address: http://vcr.tums.ac.ir
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Dr. Mohammad Ali Sahraian
Full name of responsible person - Persian: دکتر محمد علی صحرائیان
Street address - English: Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
Street address - Persian: تهران.بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1417653761
Phone: +98 21 8163 3685
Fax: +98 21 8163 3686
Email: vcr@tums.ac.ir
Web page address: http://vcr.tums.ac.ir
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Dr. Mohammad Ali Sahraian Full name of responsible person - Persian: دکتر محمد علی صحرائیان Street address - English: Tehran. Keshavarz Boulevard, Quds Ave.Sixth Floor, Central UniversityStaff Building, Sixth FloorTehran University of Medical Sciences, Tehran, Iran Street address - Persian: تهران.بلوار کشاورز، نبش خیابان قدس، سازمان مرکزی دانشگاه، طبقه ششم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1417653761 Phone: +98 21 8163 3685 Fax: +98 21 8163 3686 Email: vcr@tums.ac.ir Web page address: http://vcr.tums.ac.ir
Protocol summary
Study aim
Efficacy of the percutaneous tibial nerve stimulation in the treatment of OABS (Over Active Bladder Syndrome ) in both technique :unilateral and bilateral nerve stimulating
Design
Using the online site sealedenvelop.com (the site for sequencing block randomization) The four blocks are randomly assigned to patients in two groups: A: The patient receives only one electrode, and B: The patient receives both electrodes (standard treatment).
The order in which the patients are placed to receive the electrode is provided to the technician.
The study is Double blind. (Patient and surgeon)
32 patients referred to Sinai Hospital (with ethical consent) are studied.
The study is an intervention, phase 3, parallel and therapeutic.
Settings and conduct
This clinical trial will be performed on 32 patients at Sina Hospital.
Double blind(Patient and surgeon)
Technician (importer of patients in each group based on random blocks)
Random blocks, four blocks randomly from patients
A: an electrode
B: two electrodes
8 quadruple blocks are made which are placed in separate envelopes.
Randomized blocks are given to a technician.
After the patient enters, the technician performs the intervention by opening each envelope regarding the intervention method (A or B) for the patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 18 to 50 years
Patients with OAB
Exclusion criteria:People with neurological disease
People with any cancer
History of chemotherapy or radiotherapy
History of pelvic surgery includes history of urological surgery
Intervention groups
First Intervention Group: One-way PTNS
Second Intervention Group:Two-way PTNS (Standard treatment)
Main outcome variables
Urgent urinary incontinence
General information
Reason for update
Due to the low number of resistant PTNS patient samples, the number of samples was reduced to 32, 16 in each group.
Acronym
OABS (Over Active Bladder Syndrome )
IRCT registration information
IRCT registration number:IRCT20190624043991N7
Registration date:2020-07-31, 1399/05/10
Registration timing:registered_while_recruiting
Last update:2020-08-24, 1399/06/03
Update count:1
Registration date
2020-07-31, 1399/05/10
Registrant information
Name
Seyed Mohammad Kazem Aghamir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6634 8560
Email address
mkaghamir@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-11-11, 1398/08/20
Expected recruitment end date
2020-09-20, 1399/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of the percutaneous tibial nerve stimulation in the treatment of OABS (Over Active Bladder Syndrome ) in both technique :unilateral and bilateral nerve stimulating
Public title
percutaneous tibial nerve stimulation in the treatment of Over Active Bladder Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged 18 to 50 years
Patients with OAB
Exclusion criteria:
People with neurological disease
People with any cancer
History of chemotherapy or radiotherapy
History of pelvic surgery includes history of urological surgery
Age
From 18 years old to 50 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
32
Randomization (investigator's opinion)
Randomized
Randomization description
The present study is a double-blind randomized clinical trial.
For randomization, the blanced block randomization method is used to generate four blocks. Intervention group A and control group B have been determined.According to the randomization method, we expect the two groups to differ by a maximum of 2 people in terms of the number of people assigned.
After the methodologist prepares the randomization sequence using the sealdenvelop online site, the generated sequence will be made available to a technician outside the research team.Quadruple blocks (A or B) are placed in envelopes. After the arrival of the first patient with the inclusion criteria, the envelopes are randomly selected and the type of patient group is informed to the research team through a trained technician.The patient is placed in unilateral or bilateral nerve stimulating treatment group based on the randomly selected envelope.
Blinding (investigator's opinion)
Double blinded
Blinding description
Patients who have given their consent to participate in the study and Therapist
To perform the blinding process, envelopes related to the type of intervention are provided only to the technician.
The physician is not informed of the type of intervention (bilateral or unilateral) (to avoid bias).
In both methods of intervention, two electrodes are connected to the patient, but randomly, the electrode current is one-way or two-way. Therefore, the patient will not know 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 for Research in Tehran University of Medical Sciences
Street address
Room 604, Sixth Floor, medical University Tehran, Central Staff Building, Keshavarz Blvd., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2020-03-11, 1398/12/21
Ethics committee reference number
IR.TUMS.VCR.REC.1398.1041
Health conditions studied
1
Description of health condition studied
Over Active Bladder Syndrome
ICD-10 code
N32.81
ICD-10 code description
Overactive bladder
Primary outcomes
1
Description
urgent incontinence
Timepoint
At the end of the first day after treatment, at the end of the first week, and at the end of the first month after treatment
Method of measurement
Daily bladder function report
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: One-way PTNS. Using the delicate needle of the electrode attached to the upper thigh stimulator of patients with OAB, we access the tibial nerve. In a one-way PTNS, an electrode is installed on both lower limbs of the patient, but current flows through one of the electrodes.
Category
Treatment - Other
2
Description
Intervention group: Two-way PTNS. Using the delicate needle of the electrode attached to the upper thigh stimulator of patients with OAB, we access the tibial nerve. In a two-way PTNS, the electrode is mounted on both lower limbs of the patient and passes through both current electrodes.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sina Hospital
Full name of responsible person
Dr Mohammad Kazem Aghamir
Street address
Hassan Abad
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8500
Fax
+98 21 6634 8553
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Mohammad Ali Sahraian
Street address
Sixth Floor, Central Staff Building, Tehran University of Medical Sciences, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3685
Fax
+98 21 8163 3686
Email
vcr@tums.ac.ir
Web page address
http://vcr.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammad Kazem Aghamir
Position
Head of Urology Research Center
Latest degree
Specialist
Other areas of specialty/work
Urology
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mkaghamir@tums.ac.ir
Web page address
http://urc.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akram Mirzaei
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
Urology Research Center- Sina Hospital - Imam Khomeini St
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6634 8560
Fax
+98 21 6634 8561
Email
mirzaee.scholar@gmail.com
Web page address
https://URC@tums.ac.ir
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
No - There is not 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
demographic information anonymously
When the data will become available and for how long
one year after publication
To whom data/document is available
Researchers working in academia, physicians, surgeons and hospitals
Under which criteria data/document could be used
Re-information for the purpose of clarification Using data by referring to the article's original Get permission from the author of the article and the presenter
From where data/document is obtainable
Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
What processes are involved for a request to access data/document
After reviewing the information by the administrator and epidemiologist, the patient information will be available for the applicant by the provision of a patient's privacy.