<?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>IRCT20140202016455N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2018-11-03</date_registration>
      <primary_sponsor>Iran University of Medical Sciences</primary_sponsor>
      <public_title>The effect of pelvic floor physiotherapy on the treatment of urinary incontinence</public_title>
      <acronym></acronym>
      <scientific_title>The effect of pelvic floor physiotherapy (exercise therapy and biofeedback) with weight loss protocol in the treatment of some clinical signs of obese women with urinary incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2015-09-23</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/32123</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Blinding description: In this study, evaluator, Clinical care and data analyzer were blinded to treatment type in groups. The evaluator evaluated only the patients whom the researcher introduced to her in terms of the criteria of the study and there was no Information about type of treatment who receive. In order to ensure that the evaluator was not informed, the clinical attendant was present at the site and monitored how the evaluator contacted (in order not to be aware of the type of treatment received).
Clinical care was only familiar with the patient's name and was completely blind for the type of treatment she received.
Due to the patient's coding, The data analyzer also did not have any information about assigning codes to the patients and the type of treatment received by each person.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Urinary Incontinece.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: In addition to biofeedback therapy (Enraf, build the Netherlands) and pelvic floor exercises, which included modified Kegel and knack exercises, the intervention group received weight loss treatment. The weight loss program was performed by the patient himself on the advice of the therapist. The proposed diet was scheduled to be based on the advice of physicians for weight loss of about 700 grams per week. Pelvic floor exercises perfomed regularly and daily at home. Exercises should be performed three times a day at home so that each time it contains 2 repetitions and each repetition has 10 contractions. Between each contraction requires a few seconds of rest (according to the progress of the therapeutic sessions), and also between the repetitions we need for two minutes of rest.The exercises are in a variety of situations, lying, sitting, and standing up to progress during performance. Exercise for fast fibers was performed three times a day at home. From the third week of training, knack training also began. The exercise with biofeedback started from the second week and was performed once a week at the clinic. Biofeedback training started in short time (3 sec contraction and 8 second rest) and total duration of 10 minutes, and gradually began to contraction and rest for 10 seconds for a total of 20 minutes. The practice with the ball and tilt board was also started from the 9th session. The total treatment time is about 30 to 45 minutes and the entire treatment period is three months. Intervention 2: Control group: The control group received only pelvic floor exercises and biofeedback  therapy (Enraf, build the Netherlands). the following protocol was selected for exercises at home: Exercises should be performed three times a day at home so that each time it contains 2 repetitions and each repetition has 10 contractions. Between each contraction requires a few seconds of rest (according to the progress of the therapeutic sessions), and also between the repetitions we need for two minutes of rest. The exercises are in a variety of situations, lying, sitting, and standing up to progress during performance. Exercise for fast fibers was performed three times a day at home. From the third week of training, knack training also began. The exercise with biofeedback started from the second week and was performed once a week at the clinic. Biofeedback training started in short time (3 sec contraction and 8 second rest) and total duration of 10 minutes, and gradually began to contraction and rest for 10 seconds for a total of 20 minutes. The practice with the ball and tilt board was also started from the 9th session. The total treatment time is about 30 to 45 minutes and the entire treatment period is three months.</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 currently no plan to publish it.
No more information.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Behnoosh Vasaghi Gharamaleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran St, Shahnazari St, Mirdamad St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>Bvasaghi@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Behnoosh Vasaghi Gharamaleki</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Madadkaran St, Shahnazari St, Mirdamad St</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۳۴۸۷ - ۱۵۴۵۹</zip>
        <telephone>+98 21 2222 8051</telephone>
        <email>Bvasaghi@gmail.com</email>
        <affiliation>Iran University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Married women
Aged 25 to 65
Body mass index of 30-55 kg/m 2
The presence of real urinary incontinence at least once a week</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>65 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Genitourinary infection
Pregnancy or delivery history in the last 6 months
History of surgery for urinary incontinence or any type of surgery in the pelvic region and the urogenital area
Neurological urinary incontinence
Functional urinary incontinence
Coronary artery disease
Uncontrolled hypertension</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.4</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Other specified urinary incontinence</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 addition to biofeedback therapy (Enraf, build the Netherlands) and pelvic floor exercises, which included modified Kegel and knack exercises, the intervention group received weight loss treatment. The weight loss program was performed by the patient himself on the advice of the therapist. The proposed diet was scheduled to be based on the advice of physicians for weight loss of about 700 grams per week. Pelvic floor exercises perfomed regularly and daily at home. Exercises should be performed three times a day at home so that each time it contains 2 repetitions and each repetition has 10 contractions. Between each contraction requires a few seconds of rest (according to the progress of the therapeutic sessions), and also between the repetitions we need for two minutes of rest.The exercises are in a variety of situations, lying, sitting, and standing up to progress during performance. Exercise for fast fibers was performed three times a day at home. From the third week of training, knack training also began. The exercise with biofeedback started from the second week and was performed once a week at the clinic. Biofeedback training started in short time (3 sec contraction and 8 second rest) and total duration of 10 minutes, and gradually began to contraction and rest for 10 seconds for a total of 20 minutes. The practice with the ball and tilt board was also started from the 9th session. The total treatment time is about 30 to 45 minutes and the entire treatment period is three months.</i_keyword>
      <i_keyword>Control group: The control group received only pelvic floor exercises and biofeedback  therapy (Enraf, build the Netherlands). the following protocol was selected for exercises at home: Exercises should be performed three times a day at home so that each time it contains 2 repetitions and each repetition has 10 contractions. Between each contraction requires a few seconds of rest (according to the progress of the therapeutic sessions), and also between the repetitions we need for two minutes of rest. The exercises are in a variety of situations, lying, sitting, and standing up to progress during performance. Exercise for fast fibers was performed three times a day at home. From the third week of training, knack training also began. The exercise with biofeedback started from the second week and was performed once a week at the clinic. Biofeedback training started in short time (3 sec contraction and 8 second rest) and total duration of 10 minutes, and gradually began to contraction and rest for 10 seconds for a total of 20 minutes. The practice with the ball and tilt board was also started from the 9th session. The total treatment time is about 30 to 45 minutes and the entire treatment period is three months.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The severity of urinary incontinence. Timepoint: At the beginning and Immediately after treatment at the end of the 12th session. Method of measurement: International consultation on incontinence questionnaire -short form.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: At the beginning and Immediately after treatment at the end of the 12th session. Method of measurement: Incontinence quality of life questionnaire.</prim_outcome>
      <prim_outcome>Strength of pelvic floor muscles. Timepoint: At the beginning and Immediately after treatment at the end of the 12th  session. Method of measurement: Standard prineometer, Oxford modified scale.</prim_outcome>
      <prim_outcome>Weight. Timepoint: At the beginning and Immediately after treatment at the end of the 12th session. Method of measurement: Standard scale.</prim_outcome>
      <prim_outcome>Body Mass Index. Timepoint: At the beginning and Immediately after treatment at the end of the12th  session. Method of measurement: Standard Scale, Standard Strip meter.</prim_outcome>
      <prim_outcome>Pelvic floor muscles endurance. Timepoint: At the beginning and Immediately after treatment at the end of the 12th  session. Method of measurement: Standard prineometer, Oxford modified scale.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Waist circumference. Timepoint: Before and after treatment. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Hip circumference. Timepoint: Before and after treatment. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Neck circumference. Timepoint: Before and after treatment. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: Before and after treatment. Method of measurement: Strip meter.</sec_outcome>
      <sec_outcome>Waist to height ratio. Timepoint: Before and after treatment. Method of measurement: Strip meter.</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>Iran University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2015-12-27</approval_date>
        <contact_name>Ethics committee of Iran University Medical Science</contact_name>
        <contact_address>Iran University of Medical Sciences, Hemmat Highway, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
