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General information
3
N/A
3na
2020-11-16, 1399/08/26
2022-05-22, 1401/03/01
20202022-1105-1622 00:00:00
2021-02-19, 1399/12/01
2022-07-23, 1401/05/01
20212022-0207-1923 00:00:00
2021-04-21, 1400/02/01
2022-06-01, 1401/03/11
20212022-0406-2101 00:00:00
2021-08-06, 1400/05/15
2022-09-01, 1401/06/10
20212022-0809-0601 00:00:00
2021-10-12, 1400/07/20
2022-09-01, 1401/06/10
20212022-1009-1201 00:00:00
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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
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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با سلام
احتراما به استحضار می رساند با توجه به شرایط پاندمی کووید-19 و عدم دسترسی به بیماران واجد شرایط ورود به مطالعه و همچنین تاخیری که در دریافت تائیدیه نهایی IRCT f بوجود آمد، تاریخ های درج شده در پروتکل اولیه این مطالعه که همگی به زمان قبل از تاریخ رجیستری IRCT برمیگشتند اصلاح گردید. با این توضیح که تاریخ دقیق بیمارگیری و انجام این مطالعه در بازه زمانی یازدهم خردادماه 1401 تا دهم شهریور ماه 1401 می باشد.
با سلام احتراما به استحضار می رساند با توجه به شرایط پاندمی کووید-19 و عدم دسترسی به بیماران واجد شرایط ورود به مطالعه و همچنین تاخیری که در دریافت تائیدیه نهایی IRCT f بوجود آمد، تاریخ های درج شده در پروتکل اولیه این مطالعه که همگی به زمان قبل از تاریخ رجیستری IRCT برمیگشتند اصلاح گردید. با این توضیح که تاریخ دقیق بیمارگیری و انجام این مطالعه در بازه زمانی یازدهم خردادماه 1401 تا دهم شهریور ماه 1401 می باشد.
Protocol summary
Study aim
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.
Design
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.
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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.
Intervention groups
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.
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
Acronym
IRCT registration information
IRCT registration number:IRCT20210415050979N1
Registration date:2022-06-06, 1401/03/16
Registration timing:registered_while_recruiting
Last update:2022-11-04, 1401/08/13
Update count:2
Registration date
2022-06-06, 1401/03/16
Registrant information
Name
Sajede Mousavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 5229 2936
Email address
sajede.mousavi72@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-22, 1401/03/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
2022-06-01, 1401/03/11
Actual recruitment end date
2022-09-01, 1401/06/10
Trial completion date
2022-09-01, 1401/06/10
Scientific title
The Efficacy of Electro-acupuncture with Kinesiotape Compared to Biofeedback for Controlling Urinary Symptoms in Patients with Urinary Incontinence
Public title
The Efficacy of Electro-acupuncture with Kinesiotape in Patients with Urinary Incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
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
Age
From 20 years old to 80 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
60
Actual sample size reached:
51
Randomization (investigator's opinion)
Randomized
Randomization description
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.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants would not be aware of the intervention and control groups in this study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
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Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
International Consultation on Incontinence Questionnaire Female Lower Urinary Tract Symptoms Modules (ICIQ-FLUTS)
Secondary outcomes
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Intervention groups
1
Description
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.
Category
Treatment - Other
2
Description
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.