<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20200912048692N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2020-09-18</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>Evaluation of the Therapeutic Effect of Pelvic Floor Muscles Training with Biofeedback in Stress Urinary Incontinence</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Therapeutic Effect of Pelvic Floor Muscles Training alone with Pelvic Floor Muscles Training and Biofeedback in patients with Stress Urinary Incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2019-04-21</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/50882</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress Urinary Incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In the first session, the patient is given the necessary training about this method, the questionnaires are completed. The proposed program for these patients is 3 weeks of Kegel exercises 4 times a day for 15 minutes. Simultaneous biofeedback of ten sessions, each session is taught and each session It lasts for 15 minutes and is performed under the supervision of a researcher every other day for 3 weeks in a physiotherapy center. To reduce the patient's stress and create more relaxation, a large sheet is used as a patient cover. (EMG. Biofeedback MYTII, EB Neuro)The computer monitor, which is connected to the biofeedback device, is placed in front of the patient and then the probe of the device is impregnated with lubricant gel and placed in the patient's vagina so that the probe electrodes are placed on the pelvic floor muscles and the electrode is inactive. It is tied to the patient's hand or foot. Intervention 2: Control group: In Kegel group, exercises include a series of contractions of the pelvic floor muscles for 6 to 8 seconds and a 5 second rest that is performed in different positions, including lying down, sitting, standing, and patients are advised to do four times in Do these exercises for 15 minutes each day for 3 consecutive weeks.</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is There is no more information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Vahid Sadr Blourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al Anbya Hospital, Daneshgah Blvd</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616677856</zip>
        <telephone>+98 25 3293 0207</telephone>
        <email>azin.rahimii94@gmail.com</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Vahid Sadr Blourian</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Khatam al Anbya Hospital, Dneshgah Blvd</address>
        <city>Shahroud</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>3616677856</zip>
        <telephone>+98 25 3293 0207</telephone>
        <email>azin.rahimii94@gmail.com</email>
        <affiliation>Shahroud University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>No pregnancy and lactation
Do not use exercise to treat Stress Urinary Incontinence
Balanced mental state
No urinary tract and genital infections
No contraindications to exercise therapy
No using surgical treatments to treat incontinence in the past
No Pelvic Cancers
Do not take drugs that affect the urine
Women aged 40 to 70 years</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>70 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>6 months or less after delivery
Have any surgery on the pelvic and genital areas
Stool incontinence
Having physical illnesses (Cancer and physical disability) that prevent clients from cooperating</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence (female)</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: In the first session, the patient is given the necessary training about this method, the questionnaires are completed. The proposed program for these patients is 3 weeks of Kegel exercises 4 times a day for 15 minutes. Simultaneous biofeedback of ten sessions, each session is taught and each session It lasts for 15 minutes and is performed under the supervision of a researcher every other day for 3 weeks in a physiotherapy center. To reduce the patient's stress and create more relaxation, a large sheet is used as a patient cover. (EMG. Biofeedback MYTII, EB Neuro)The computer monitor, which is connected to the biofeedback device, is placed in front of the patient and then the probe of the device is impregnated with lubricant gel and placed in the patient's vagina so that the probe electrodes are placed on the pelvic floor muscles and the electrode is inactive. It is tied to the patient's hand or foot</i_keyword>
      <i_keyword>Control group: In Kegel group, exercises include a series of contractions of the pelvic floor muscles for 6 to 8 seconds and a 5 second rest that is performed in different positions, including lying down, sitting, standing, and patients are advised to do four times in Do these exercises for 15 minutes each day for 3 consecutive weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Comparison of the therapeutic effect of pelvic floor muscle training alone with pelvic floor muscle training and biofeedback in patients with stress urinary incontinence by age. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor muscle exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the therapeutic effect of pelvic floor muscle training alone with pelvic floor muscle training and biofeedback in patients with stress urinary incontinence by weight. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor muscle exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the therapeutic effect of pelvic floor muscle training alone with pelvic floor muscle training and biofeedback in patients with stress urinary incontinence by type of delivery. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor muscle exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the therapeutic effect of pelvic floor muscle training alone with pelvic floor muscle training and biofeedback in patients with stress urinary incontinence according to body mass index. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor muscle exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the therapeutic effect of pelvic floor muscle training alone with pelvic floor muscle training and biofeedback in patients with stress urinary incontinence according to the duration of incontinence. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor muscle exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</prim_outcome>
      <prim_outcome>Comparison of the therapeutic effect of pelvic floor muscle training alone with pelvic floor muscle training and biofeedback in patients with stress urinary incontinence by number of pregnancies. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor muscle exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Quality of life score. Timepoint: At the beginning of the study (before the intervention) and 21 days after pelvic floor exercises and biofeedback. Method of measurement: Incontinence Quality of Life questionnaire.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2019-07-04</approval_date>
        <contact_name>Ethics committee of Shahroud University of Medical Sciences</contact_name>
        <contact_address>University Blvd., Faculty of Medical Sciences, Shahroud Azad University Shahroud Semnan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
