Protocol summary
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Study aim
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Comparison of the therapeutic effect of electroacupuncture with kinesiotape in comparison with biofeedback in controlling the symptoms of patients with stress, urgency and mixed urinary incontinence in patients aged 20-80 years referred to Mahdieh Hospital.
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Design
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Clinical trial, with two intervention groups, with parallel groups, one-way blind, randomized, on 60 patients, block randomization method based on statistical equations was used for randomization.
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Settings and conduct
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Randomized clinical trial is a single-blind study performed on patients with stress, urgency and mixed incontinence referred to Mahdieh Hospital. Patients were randomly divided into two groups, neither of which knew about the intervention process of the other group.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:Women with stress, urgency and mixed urinary incontinence in the age range of 20-80 years, who have had symptoms for at least three months, and are referred by gynecologists, general surgeons and urologists.
Exclusion criteria:Patients with , upper motor neuron disease, such as cerebral palsy, multiple sclerosis, spinal cord injury, stroke, recent perineal Truman(less than 3 month ago), history of genital surgery and diabetes mellitus.
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Intervention groups
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The first group is treated with electroacupuncture and kinesiotype for 5 sessions of 20 minutes (including 10 minutes of continuous stimulation and 10 minutes of pulse).
The second group is treated with biofeedback for 5 sessions of 20 minutes with a protocol of 10 minutes of electrical stimulation each session and then 10 minutes of active strengthening of the pelvic floor muscles through a rectal probe with due regard to health issues.
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Main outcome variables
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Improvement percentage of urinary incontinence, nocturia, urgent urinary incontinence, stress urinary incontinence
General information
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Reason for update
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To whom it may be a concern,
Due to the Covid-19 pandemic, we could not recruit eligible participants for the study based on the recorded dates in the primary protocol. In this study, the actual recruitment dates were modified and reported in the updated version of the protocol.
Thank you very much for your kind attention.
Regards,
Dr. Mousavi
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20210415050979N1
Registration date:
2022-06-06, 1401/03/16
Registration timing:
prospective
Last update:
2022-11-19, 1401/08/28
Update count:
2
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Registration date
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2022-06-06, 1401/03/16
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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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2022-05-22, 1401/03/01
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Expected recruitment end date
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2022-07-23, 1401/05/01
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Actual recruitment start date
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2022-06-10, 1401/03/20
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Actual recruitment end date
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2022-07-10, 1401/04/19
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Trial completion date
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2022-09-10, 1401/06/19
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Scientific title
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The Efficacy of Electro-acupuncture with Kinesiotape Compared to Biofeedback for Controlling Urinary Symptoms in Patients with Urinary Incontinence
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Public title
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The Efficacy of Electro-acupuncture with Kinesiotape in Patients with Urinary Incontinence
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Patients with urinary stress or urgent incontinence
Patients with a history of at least three months of urinary incontinence complications
Women aged between 20 to 80 years
Exclusion criteria:
Patients with , upper motor neuron disease, such as cerebral palsy, multiple sclerosis, Stroke, spinal cord injury
Recent perineal trauma(Less than three months ago)
History of genital surgery
diabetes mellitus
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Age
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From 20 years old to 80 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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Sample size
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Target sample size:
60
Actual sample size reached:
43
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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In this clinical trial study, 60 patients with complications related to urinary incontinence will be included in the study. For random allocation of individuals in the study groups (intervention group and comparison group), the method of random allocation with block method (Block Randomization) will be used. In this method, blocks with a size of six (including three people in the intervention group and three people in the comparison group) with a ratio of 1:1 will be used. Random Allocation software will be used to generate random sequences. The random allocation concealment method is used in such a way that random sequences are created. In this method, they are identified on the cards and these cards are placed inside the sealed envelopes in order. In order to maintain the created sequence, the numbering will be recorded on the outer surface of the envelopes. Finally, the numbered envelopes will be placed in a folder. Then, according to the order of entry of the eligible participants, the envelopes will be opened and the assigned group of the participant will be determined.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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Participants would not be aware of the intervention and control groups in this study.
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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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2021-01-31, 1399/11/12
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Ethics committee reference number
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IR.SBMU.RETECH.REC.1399.1011
Health conditions studied
1
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Description of health condition studied
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Stress incontinence
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ICD-10 code
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N39.3
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ICD-10 code description
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Stress incontinence (female) (male)
2
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Description of health condition studied
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Urge incontinence
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ICD-10 code
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N39.41
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ICD-10 code description
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Urge incontinence
Primary outcomes
1
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Description
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Improvement percentage in urinary incontinence
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Timepoint
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Before, After treatment, 2 months after treatment
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Method of measurement
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International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
Intervention groups
1
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Description
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People in the first group are treated with electroacupuncture for 5 sessions for 20 minutes. During this period, patients are subjected to continuous stimulation for 10 minutes and pulsed stimulation for 10 minutes via an acupuncture needle. 4 needles are placed at the same distance from the ASIS area to the tubercle pubic area. The needles are spaced from the pulse of the artery. At the end of each treatment session, all members of this group are treated with pelvic floor kinesiotype. Pelvic floor typing is from pubic tubercle to ASIS, which is without tension on both sides and 50% in the middle with tension. All patients were instructed in how to care for the kinesiotype, and did not separate the kinesiotype until the next treatment session.
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Category
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Treatment - Other
2
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Description
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The second group is treated with biofeedback for 5 sessions of 20 minutes, which includes 10 minutes of electrical stimulation and 10 minutes of active muscle contraction with auditory and visual feedback. These stimulations are applied through a rectal probe in accordance with health standards.
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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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Shahid Beheshti 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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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Not applicable
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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