<?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>IRCT20220804055615N2</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-12-08</date_registration>
      <primary_sponsor>Memon Medical Intitute Hospital</primary_sponsor>
      <public_title>Effectiveness of pelvic floor muscle training with or without biofeedback therapy for urinary incontinence</public_title>
      <acronym></acronym>
      <scientific_title>Effectiveness of pelvic floor muscle training with or without biofeedback therapy for urinary incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-10-01</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>24</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/65847</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: 4, Randomization description: Patients refereed from  Gynecology out patient department. We will maintain a excel sheet on computer every odd number will consider in controlled group and even number in conventional group. 
We will use biofeedback therapy machine for controlled group, Blinding description: Patients with the complain of urinary incontinence filled the concern form for study but not inform regarding two different groups, distributed the patients with odd and even numbers in two groups.</study_design>
      <phase>2-3</phase>
      <hc_freetext>pelvic floor muscles weakness.</hc_freetext>
      <i_freetext>Intervention 1: In intervention group participants will be treated with bio feed back therapy followed by pelvic floor exercises. bio feed back therapy(exercises) 30 minutes session done with a machine of enraf nonius  with brand name of myomed. In inventional group there will be no intervention of any chemical. Total sessions  of exercises will be 12 and 3 session in a week. duration of study is 3 month. Intervention 2: Controlled group will treated with conventional pelvic floor exercises only.</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>Yes - There is a plan to make this available</results_IPD_plan>
      <results_IPD_description>What will be shared:
Effectiveness of Pelvic floor muscles training with or without biofeedback therapy for urinary incontinence

When:
With in 3 three month

To whom:
Data will be available only who are working in the out patient department

Conditions:
Data not allowed to others

Where to obtain:
Out patients department

How to obtain:
Not allowed to any other researchers

Comments:
This is gynecology and physiotherapy department research</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Dr. Mohabbat Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safoora Goth</address>
        <city>karachi</city>
        <country1>Pakistan</country1>
        <zip>75270</zip>
        <telephone>+92 21 99261810</telephone>
        <email>ramal_209@yahoo.com</email>
        <affiliation>Memon Medical Instute Hospital</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Dr. Mohabbat Ali</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Safoora goth</address>
        <city>Karachi</city>
        <country1>Pakistan</country1>
        <zip>75270</zip>
        <telephone>+92 21 99261810</telephone>
        <email>ramal_209@yahoo.com</email>
        <affiliation>Memon Medical Institute Hospital</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patient who are willing to participate in the study.
Menopausal women
Pre and post-menopause
Urinary incontinence with the effort
Age limit is 19-50 years</inclusion_criteria>
      <agemin>19 years</agemin>
      <agemax>50 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Experiencing psychotic symptoms at baseline
Females with neurological conditions that affect sphincteric function or colorectal, pelvic, gynecological or genitourinary
Surgery or malignancy where the exciting pathology interferes with the prescribed pelvic floor muscle training program will exclude
Biofeedback-assisted pelvic floor muscle training were not suitable will also exclude</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N39.46</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Mixed incontinence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>In intervention group participants will be treated with bio feed back therapy followed by pelvic floor exercises. bio feed back therapy(exercises) 30 minutes session done with a machine of enraf nonius  with brand name of myomed. In inventional group there will be no intervention of any chemical. Total sessions  of exercises will be 12 and 3 session in a week. duration of study is 3 month</i_keyword>
      <i_keyword>Controlled group will treated with conventional pelvic floor exercises only</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Pelvic floor muscles weakness. Timepoint: 3 month. Method of measurement: Muscle will measure by biofeedback therapy.</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>Memon Medical Intitute Hospital</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-10-10</approval_date>
        <contact_name>Intitutional Review Board Memon Medical Institute Hospital</contact_name>
        <contact_address>Safoora Goth Scheme 33 Karachi Sindh Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
