Protocol summary
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Study aim
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Efficacy of the percutaneous tibial nerve stimulation in the treatment of OABS (Over Active Bladder Syndrome ) in both technique :unilateral and bilateral nerve stimulating
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Design
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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.
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Settings and conduct
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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.
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Participants/Inclusion and exclusion criteria
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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
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Intervention groups
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First Intervention Group: One-way PTNS
Second Intervention Group:Two-way PTNS (Standard treatment)
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Main outcome variables
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Urgent urinary incontinence
General information
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Reason for update
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Due to the low number of resistant PTNS patient samples, the number of samples was reduced to 32, 16 in each group.
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Acronym
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OABS (Over Active Bladder Syndrome )
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IRCT registration information
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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
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Registration date
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2020-07-31, 1399/05/10
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-11-11, 1398/08/20
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Expected recruitment end date
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2020-09-20, 1399/06/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Efficacy of the percutaneous tibial nerve stimulation in the treatment of OABS (Over Active Bladder Syndrome ) in both technique :unilateral and bilateral nerve stimulating
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Public title
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percutaneous tibial nerve stimulation in the treatment of Over Active Bladder Syndrome
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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3
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Groups that have been masked
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- Participant
- Care provider
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Sample size
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Target sample size:
32
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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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.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-03-11, 1398/12/21
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Ethics committee reference number
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IR.TUMS.VCR.REC.1398.1041
Health conditions studied
1
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Description of health condition studied
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Over Active Bladder Syndrome
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ICD-10 code
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N32.81
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ICD-10 code description
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Overactive bladder
Primary outcomes
1
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Description
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urgent incontinence
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Timepoint
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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
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Method of measurement
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Daily bladder function report
Intervention groups
1
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Tehran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available
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Title and more details about the data/document
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demographic information anonymously
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When the data will become available and for how long
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one year after publication
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To whom data/document is available
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Researchers working in academia, physicians, surgeons and hospitals
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Under which criteria data/document could be used
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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
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From where data/document is obtainable
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Sina Hospital, Urology Research Center, Head of Urology Research Center: Dr. Seyed Mohammad Kazem Aghamir 00982166348560
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What processes are involved for a request to access data/document
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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.
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Comments
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