<?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>IRCT20161221031506N9</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-07-10</date_registration>
      <primary_sponsor>Mashhad University of Medical Sciences</primary_sponsor>
      <public_title>Comparing the Combined Effect of Stability Exercises with Emphasis on Pelvic Floor Muscles and Interference Current on Improving the symptoms of Women with Stress Urinary Incontinence</public_title>
      <acronym></acronym>
      <scientific_title>Comparing the Combined Effect of Stability Exercises and Interference Current in Improving Maximal Intravaginal Pressure, Frequency of Urinary Incontinence, and Quality of Life in Women with Stress Urinary Incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-08-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/64366</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The random numbers is prepared using the website www.sealedenvelope.com in terms of 1 and 2. The 22 cards (taking into account 20% dropout) is placed into sealed envelopes. After the evaluation, the patients selected the card according to the order placed in the envelope. If the number of 1 is observed, the patient will be included in the intervention group, and if the number of 2 is observed, the patients will be included in the control group.Another physiotherapist who is not aware about the allocation process will evaluate the patients, Blinding description: The outcome assessor and the statistical analyzer will be blinded to the group allocation. The patient will receive a placebo interferential current. The outcome assessor will evaluate the patients in a separate room. She has not any information regarding the patient group. In addition, statistical analysis will be blinded to group allocation. In the spss file, codes a, and b will be defined for intervention and control groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Stress urinary inconvenience.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: They will receive 12 sessions of interferential currents 4 weeks, 3 times per week. The intensity of the interferential currents causes the torelated contractions. Electrodes placement will be done bipolarly and by the Dumoulin method. Then, the patients will be performed the stability exercises. The patients in this group should perform the stability exercises for 4 weeks, 5 times per week. It should be noted that three out of five times will be performed under the physiotherapist' supervision. Generally, the duration of the exercises is 30 minutes per session. The patients should repeat each exercise 10-20 times in the requested positions. In the first session, people will be given exercise booklets, which contain pictures of the prescribed exercises. The patienrts should record their performed exercises during the week. The participants in the intervention group are trained to perform stability exercises while exhaling. Individuals are also asked to do diaphragmatic breathing for 3-4 minutes before starting stability exercises. This improves the blood circulation of the intestines and improves the function and rhythm of the pelvic floormuscle. Also, patients should have diaphragmatic breathing during rest periods betwwen exercises. Intervention 2: Control group:Similarly, the intervention group performs stabilization exercises 5 times a week for 4 weeks, 3 of which are performed under the supervision of a physiotherapist after receiving the placebo interference current, and the other 2 times are performed at home. Everyone is given an educational pamphlet.</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 اطلاعات بیشتری وجود ندارد</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Reyhane Sekandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3869 8719</telephone>
        <email>r.sekandari1@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Reyhane Sekandari</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Faculty of Paramedical Sciences, University campus, East entrance of Ferdowsi University of Mashhad, Azadi Square, Mashhad.</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9177948964</zip>
        <telephone>+98 51 3869 8719</telephone>
        <email>r.sekandari1@gmail.com</email>
        <affiliation>Mashhad University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Have experienced stress urinary incontinence at least twice a week for two weeks. Stress urinary incontinence was confirmed by urodynamic tests and clinical examination.
Mild and moderate stress urinary incontinence
No history of taking anticholinergic drugs and other drugs during physiotherapy period.</inclusion_criteria>
      <agemin>no limit</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>smoking
Known types of neuropathy
Virginity
Pregnancy and lactation
History of pelvic surgery in the past year
History of reconstructive surgery in the genitourinary system
Having a urinary tract infection
Chronic asthma and cough (more than three months)
Having perceptual problems and mental illness based on a doctor's examination
History of genitourinary neoplasia
History of abnormalities in the genitourinary system
Having any type of urinary incontinence other than pure stress urinary incontinence
Severe stress urinary incontinence
Severe prolapse
Urethral hyper mobility
Intrinsic sphincter dysfunction
Severe neuromuscular disorders that compromise exercise performance</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.3</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Stress incontinence (female) (male)</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: They will receive 12 sessions of interferential currents 4 weeks, 3 times per week. The intensity of the interferential currents causes the torelated contractions. Electrodes placement will be done bipolarly and by the Dumoulin method. Then, the patients will be performed the stability exercises. The patients in this group should perform the stability exercises for 4 weeks, 5 times per week. It should be noted that three out of five times will be performed under the physiotherapist' supervision. Generally, the duration of the exercises is 30 minutes per session. The patients should repeat each exercise 10-20 times in the requested positions. In the first session, people will be given exercise booklets, which contain pictures of the prescribed exercises. The patienrts should record their performed exercises during the week. The participants in the intervention group are trained to perform stability exercises while exhaling. Individuals are also asked to do diaphragmatic breathing for 3-4 minutes before starting stability exercises. This improves the blood circulation of the intestines and improves the function and rhythm of the pelvic floormuscle. Also, patients should have diaphragmatic breathing during rest periods betwwen exercises.</i_keyword>
      <i_keyword>Control group:Similarly, the intervention group performs stabilization exercises 5 times a week for 4 weeks, 3 of which are performed under the supervision of a physiotherapist after receiving the placebo interference current, and the other 2 times are performed at home. Everyone is given an educational pamphlet</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Mean maximum intravaginal pressure. Timepoint: Immediately after allocation into , 4 and 8 weeks after starting treatment. Method of measurement: Pressure biofeedback.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Immediately after allocation into , 4 and 8 weeks after starting treatment. Method of measurement: توسط پرسشنامه I_QOL.</prim_outcome>
      <prim_outcome>ICIQ_UI SF  questionnaire score. Timepoint: Immediately after allocation into , 4 and 8 weeks after starting treatment. Method of measurement: ICIQ_UI SF  questionnaire.</prim_outcome>
      <prim_outcome>Duration of maintenance of maximum intravaginal pressure. Timepoint: Immediately after allocation into , 4 and 8 weeks after starting treatment. Method of measurement: Pressure biofeedback.</prim_outcome>
      <prim_outcome>Frequent urinary incontinence for a week. Timepoint: Immediately after allocation into , 4 and 8 weeks after starting treatment. Method of measurement: With bladder diary.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome></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>Mashhad University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-06-28</approval_date>
        <contact_name>The Ethics Committee of Mashhad University of Medical Sciences</contact_name>
        <contact_address>Mashhad University of Medical Science's Research and Development Deputy Office, Across 18th University Street, University Street. Mashhad Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
