<?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>IRCT20191117045462N14</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2024-07-18</date_registration>
      <primary_sponsor>Riphah International University</primary_sponsor>
      <public_title>Combined effects of pelvic floor Hold relax and Buteyko technique on urinary incontinence, pulmonary functions and exercise tolerance in COPD patients</public_title>
      <acronym></acronym>
      <scientific_title>Combined effects of pelvic floor Hold relax and Buteyko technique on urinary incontinence, pulmonary functions and exercise tolerance in COPD patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2023-09-29</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>40</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/74000</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Taking into account the aforementioned inclusion and exclusion criteria patients will be divided into two groups by convenient sampling and allocated to 2 groups by simple randomization process by sealed opaque envelope method and labeled as 0 for group A and 1 for group B, Blinding description: Investigator will be blind. Assessment will done by 2nd therapist who will not be involved in treatment and data analysis.</study_design>
      <phase>N/A</phase>
      <hc_freetext>COPD Patients.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Behavioral Therapy along with Pelvic floor hold relax and Buteyko technique.Patients asked to do Pelvic floor hold relax like 3 sets of 8–12 maximum VPFMC and to hold the contraction for more than three seconds followed by relaxation. Begin by bladder emptying, patients squeeze the muscles around the urethra as if trying to stop the flow of urine.Buteyko technique given to patients like 8-10 repetitions of 3 sets Patient will be asked to maintain upright posture. In the 1st phase they will do normal breathing for few minutes. Use index finger and thumb to plug nose. After exhalation hold breath as they can, then again inhale and start breathing normally for 10 seconds. In 2nd phase patients will hold breath twice the timing of 1st phase.  Patients were also instructed to do exercises for twice a week for 16 weeks.Educational session given to patients about Behavioral Therapy. It includes proper fluid intake schedule that is drink more fluids in the morning and afternoon, not at night. Stop drinking a few hours before bedtime, reducing alcohol, caffeine, spicy foods, voiding interval of 2-3 hours starting from 5 minutes, stop smoking, avoid lifting. Intervention 2: Control group: Behavioral Therapy.Educational session given to patients about Behavioral Therapy. It includes proper fluid intake schedule that is drink more fluids in the morning and afternoon, not at night. Stop drinking a few hours before bedtime, reducing alcohol, caffeine, spicy foods, voiding interval of 2-3 hours starting from 5 minutes, stop smoking, avoid lifting.</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>No - There is not a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for not sharing IPD is There is no further information</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fazelat Nasir</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-civic center, township near hamdard chowk, lahore.</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Wajeeha</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>13-14-C-civic center, township near Hamdard chowk, Lahore</address>
        <city>Lahore</city>
        <country1>Pakistan</country1>
        <zip>54000</zip>
        <telephone>+92 42 35126110</telephone>
        <email>wajeeha_z@yahoo.com</email>
        <affiliation>Riphah International University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Pakistan</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Patients complaining incontinence link with cough and exercise
Age criteria 25-45 years
Patients having ability to perform voluntary pelvic floor muscle contraction and cooperative
Self-reported urinary incontinence
Stable COPD</inclusion_criteria>
      <agemin>25 years</agemin>
      <agemax>45 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Subjects having unstable COPD
Subjects with &gt;4 hospital admissions due to COPD during last 1 year
Patient ‘s having Neurological conditions and non-cooperative
Subjects having spinal cord injuries
Patients having history of Hysterectomy and other gynecological surgeries
Patients having Malignancy</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>J44.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Chronic obstructive pulmonary disease, unspecified</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: Behavioral Therapy along with Pelvic floor hold relax and Buteyko technique.Patients asked to do Pelvic floor hold relax like 3 sets of 8–12 maximum VPFMC and to hold the contraction for more than three seconds followed by relaxation. Begin by bladder emptying, patients squeeze the muscles around the urethra as if trying to stop the flow of urine.Buteyko technique given to patients like 8-10 repetitions of 3 sets Patient will be asked to maintain upright posture. In the 1st phase they will do normal breathing for few minutes. Use index finger and thumb to plug nose. After exhalation hold breath as they can, then again inhale and start breathing normally for 10 seconds. In 2nd phase patients will hold breath twice the timing of 1st phase.  Patients were also instructed to do exercises for twice a week for 16 weeks.Educational session given to patients about Behavioral Therapy. It includes proper fluid intake schedule that is drink more fluids in the morning and afternoon, not at night. Stop drinking a few hours before bedtime, reducing alcohol, caffeine, spicy foods, voiding interval of 2-3 hours starting from 5 minutes, stop smoking, avoid lifting.</i_keyword>
      <i_keyword>Control group: Behavioral Therapy.Educational session given to patients about Behavioral Therapy. It includes proper fluid intake schedule that is drink more fluids in the morning and afternoon, not at night. Stop drinking a few hours before bedtime, reducing alcohol, caffeine, spicy foods, voiding interval of 2-3 hours starting from 5 minutes, stop smoking, avoid lifting.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary incontinence and Pulmonary functions. Timepoint: Pre-Post Treatment. Method of measurement: International consultation on Incontinence Questionnaire (ICIQ-UI-SF) and for pulmonary functions Master Screen PFT system.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Exercise tolerance. Timepoint: Pre-Post Treatment. Method of measurement: 6 Minute walk test.</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>Riphah International University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2023-11-23</approval_date>
        <contact_name>Riphah college of rehabilitation and Allied Health Sciences</contact_name>
        <contact_address>13-14-C-civic center, township near Hamdard Chowk Lahore. Lahore Punjab Pakistan</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
