<?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>IRCT20221205056713N4</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-08-02</date_registration>
      <primary_sponsor>Rashid Latif Medical college</primary_sponsor>
      <public_title>Pelvic floor strengthening exercises in stress urinary incontinence patients</public_title>
      <acronym></acronym>
      <scientific_title>Effect of knack  maneuver with or without diaphragmatic breathing on urinary tract symptoms and quality of life among patients of stress urinary incontinence</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2024-07-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>30</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/77986</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly divided in two groups (group A group B) by using lottery method. Both groups will given conventional physical therapy treatment. Group A patients will be treated with the knack maneuver along diaphragmatic breathing and Group B patients will treated with the Knack maneuver. Both group will be assessed before and after the treatment, Blinding description: Subjects in two groups will blinded from other treatment options. However they will be
instructed to report any adverse effects during trial. Data will assessed by a third person which will not known about the study so trial will be single blinded study. (as outcome assessor will be blinded).</study_design>
      <phase>N/A</phase>
      <hc_freetext>stress urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: will given knack maneuver along diaphragmatic breathing.  In group A, We will take diagnosed patients of stress urinary incontinence and we will perform knack maneuver along diaphragmatic breathing. Firstly patient will perform diaphragmatic breathing, we will command patient to slowly and deeply take breaths through the nose using the diaphragmatic with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly. During breathing, we should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm. Generally, inhale and exhale for approximately six seconds. Now the patient will perform knack maneuver. During Knack training, patients is warned not to hold their breath, pull their stomach inward, strain, or contract their legs or hip muscles. The relationship between IAP increase and PFM contraction and the situations causing IAP increase (coughing, sneezing, laughing, lifting a heavy object, pushing, and bending down, etc.).The women will asked to perform the Knack maneuver before and during situations that increase intraabdominal pressure. The training program will include 2 days per week for 4 weeks. Intervention 2: Intervention group 2 will given knack maneuver. In group B, We will also take diagnosed patients of stress urinary incontinence and we will perform knack maneuver. During Knack training, patients is warned not to hold their breath, pull their stomach inward, strain, or contract their legs or hip muscles. The relationship between IAP increase and PFM contraction and the situations causing IAP increase (coughing, sneezing, laughing, lifting a heavy object, pushing, and bending down, etc.).The women will ask to perform the Knack maneuver before and during situations that increase intra-abdominal pressure.  The training program will include 2 days  per week for 4 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 It is not yet known if there will be a plan to make this available</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Saheeqa Qamar</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-KM, Ferozepur Road. Lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 313 9465214</telephone>
        <email>saheeqaqamar.77@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Hafiza Nida Rasheed</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>35-KM, Ferozepur Road. Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54900</zip>
        <telephone>+92 336 4535979</telephone>
        <email>naddia.rasheed20@gmail.com</email>
        <affiliation>Rashid Latif Medical College</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age 18 to 50 years
Patients diagnosed with stress urinary incontinence</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>50 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Women who are having previous pelvic floor training.
Pregnant women are excluded
Patients taking blood pressure medications, sedatives, muscle relaxants, and diuretics are excluded.
Patients with diagnosed mental illness are excluded</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>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: will given knack maneuver along diaphragmatic breathing.  In group A, We will take diagnosed patients of stress urinary incontinence and we will perform knack maneuver along diaphragmatic breathing. Firstly patient will perform diaphragmatic breathing, we will command patient to slowly and deeply take breaths through the nose using the diaphragmatic with a minimum movement of the chest in a supine position with one hand placed on the chest and the other on the belly. During breathing, we should be careful that chest remains as still as possible and stomach moves against the hand focusing on contracting the diaphragm. Generally, inhale and exhale for approximately six seconds. Now the patient will perform knack maneuver. During Knack training, patients is warned not to hold their breath, pull their stomach inward, strain, or contract their legs or hip muscles. The relationship between IAP increase and PFM contraction and the situations causing IAP increase (coughing, sneezing, laughing, lifting a heavy object, pushing, and bending down, etc.).The women will asked to perform the Knack maneuver before and during situations that increase intraabdominal pressure. The training program will include 2 days per week for 4 weeks</i_keyword>
      <i_keyword>Intervention group 2 will given knack maneuver. In group B, We will also take diagnosed patients of stress urinary incontinence and we will perform knack maneuver. During Knack training, patients is warned not to hold their breath, pull their stomach inward, strain, or contract their legs or hip muscles. The relationship between IAP increase and PFM contraction and the situations causing IAP increase (coughing, sneezing, laughing, lifting a heavy object, pushing, and bending down, etc.).The women will ask to perform the Knack maneuver before and during situations that increase intra-abdominal pressure.  The training program will include 2 days  per week for 4 weeks.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary tract symptoms. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Urinary distress incontinence-6.</prim_outcome>
      <prim_outcome>Quality of life. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Incontinence Impact Questionnaire (IIQ-7).</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>Rashid Latif Medical college</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-09-11</approval_date>
        <contact_name>Institutional Review Board  of Rashid Latif Medical College, Lahore</contact_name>
        <contact_address>Rashid Latif Medical Complex 35-KM, Ferozepur Road. Lahore. Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
