<?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>IRCT20211011052729N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-12-16</date_registration>
      <primary_sponsor>University of social welfare and rehabilitation sciences</primary_sponsor>
      <public_title>The impact of  urinary incontinence rehabilitation intervention on self esteem and quality of life in women with neurogenic bladder</public_title>
      <acronym></acronym>
      <scientific_title>The impact of  urinary incontinence rehabilitation intervention on self esteem and quality of life in women with neurogenic bladder in Rofeideh Rehabilitation Hospital</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-02-03</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>35</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/59269</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Urinary incontinence and neurogenic bladder.</hc_freetext>
      <i_freetext>Method of intervention: Urinary incontinence rehabilitation interventions in patients with neurogenic bladder were developed using literature review and then validated. In this way, after compiling the dimensions of urinary incontinence rehabilitation interventions in this study, using a review of the existing texts in this field, the program was compiled by 10 rehabilitation specialists, including physicians specializing in physical medicine and rehabilitation, and urologists, nutritionists. , Physiotherapist, occupational therapist and head nurses and faculty members of the nursing department with experience in rehabilitation nursing, correction, approval and accreditation. Rehabilitation intervention based on the mentioned texts and validation, including 2 dimensions of clean intermittent catheterization, behavioral therapy (determining the time of urination, delaying urination and diet and medication) in 12 sessions of 30 minutes in six weeks Which is 7 sessions in the first week and then in the second, third, fourth, fifth and sixth weeks of a week. The time of this study is from the second half of February 2021 to the end of March 2021 and the evaluation of the program in The time periods of the first week of the first session, as a pre-test (filling in the questionnaires for the first time by the clients before the intervention) and the sixth week of the twelfth session, as a post-test (filling the questionnaires for the second time by the clients after the intervention) Took. After approving the proposal and obtaining the code of ethics, sampling was done by the method available in the departments of neurology, spinal cord injury, stroke of Rofeideh Rehabilitation Hospital and was performed within a period of one month and patients with inclusion criteria were included in the study. The objectives of the study were explained to the samples and the informed consent form was completed by the patients. Neurology, spinal cord injury, stroke were completed and quality of life in urinary incontinence and self-esteem were measured before the intervention. Urinary incontinence rehabilitation interventions in a two-dimensional intervention, in 7 30-minute sessions over 1 week Individual in-person and out-of-group training due to the prevalence of Covid-19 disease was taught and at the same time an educational booklet was provided to patients. Urinary incontinence To evaluate the correct implementation of urinary incontinence rehabilitation interventions, one session was held every week. Consultation, training and follow-up of the intervention was done by telephone with the researcher. If necessary, referrals were made to medical centers. At the end of the intervention and follow-up, 6 weeks after the last training session, post-test was performed and patients again completed the research questionnaires. Educational pamphlets and urinary incontinence rehabilitation interventions were provided to hospital wards for ethics. Session 1 (Week 1): Explain the intervention and its purpose, obtaining consent from clients, pre-test, filling out questionnaires for the first time by clients / Session 2 (Week 1): Anatomy and physiology training, urinary system and how it works Session 3 (Week 1): Familiarity with neurogenic bladder and its symptoms / Session 4 (Week 1): Training of urinary incontinence rehabilitation interventions (clean intermittent catheterization) by the researcher for clients, providing all training files through the group Virtual / Session 5 (first week): Behavior therapy (setting a specific time for urination according to the urination schedule, delaying the urination time as much as possible according to the urination schedule), providing all the training files through Virtual group / Session 6 (first week): Behavior therapy (diet), providing all the training files through the virtual group / Session 7 (first week): Tracking exercises, reviewing how clients do exercises and troubleshooting By sending video and video call online, answering clients' questions / Eighth session (second week): Examining how clients do exercises And troubleshooting by sending video and video call online, answering clients 'questions / Session 9 (third week): following up on exercises, reviewing how clients perform exercises and fixing problems by sending video and video calling online, answering clients' questions / Session 10 (Week 4): Follow up the exercises, check how the exercises are done by the clients and fix the problems by sending a video and online video call, answer the questions of the clients / Session 11 (Week 5): Follow the exercises, check how to do the exercises By clients and troubleshooting by sending video and video call online, answering clients 'questions / Twelfth session (sixth week): the last session answering clients' questions, post-test, refilling questionnaires for the second time by clients, their satisfaction with the performance This intervention, feedback.</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:
Only part of the data such as information about the main outcome or the like can be shared.

When:
6 months after the results are published

To whom:
Academic people and scientific institutions

Conditions:
Ethical, legal and scientific licenses

Where to obtain:
Referred to the University of Social Welfare and Rehabilitation Sciences, Department of Nursing, Associate Professor of Nursing Dr. Narges Arsalani (Corresponding Author)
Or send an email to the address
nargesarsalani@gmail.com

How to obtain:
Ethical, legal and scientific licenses of university 
Going to university of social welfare and rehabilitation sciences

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Narges Arsalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran- Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>1985713871</zip>
        <telephone>+98 21 2218 0083</telephone>
        <email>nargesarsalani@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Narges Arsalani</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran- Iran</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۱۹۸۵۷۱۳۸۷۱</zip>
        <telephone>009822180083</telephone>
        <email>nargesarsalani@gmail.com</email>
        <affiliation>University of social welfare and rehabilitation sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Clean Intermittent catheterization according to the doctor's instructions
Literacy
Having a body mass index of less than 30 kg  per m2</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>60 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Cervical spinal cord injuries ( C1 to C7)
Alcohol and drugs
Acute depression
Taking medications that affect urinary incontinence or changing its prescription during the month before the study
Taking diuretics to lower blood pressure
َActive urinary tract infection according to the patient's test results
History of gynecological surgeries
Being pregnant
No history of cesarean section or normal delivery in the last 6 months
Pelvic floor muscle prolapse</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code></hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword></hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Method of intervention: Urinary incontinence rehabilitation interventions in patients with neurogenic bladder were developed using literature review and then validated. In this way, after compiling the dimensions of urinary incontinence rehabilitation interventions in this study, using a review of the existing texts in this field, the program was compiled by 10 rehabilitation specialists, including physicians specializing in physical medicine and rehabilitation, and urologists, nutritionists. , Physiotherapist, occupational therapist and head nurses and faculty members of the nursing department with experience in rehabilitation nursing, correction, approval and accreditation. Rehabilitation intervention based on the mentioned texts and validation, including 2 dimensions of clean intermittent catheterization, behavioral therapy (determining the time of urination, delaying urination and diet and medication) in 12 sessions of 30 minutes in six weeks Which is 7 sessions in the first week and then in the second, third, fourth, fifth and sixth weeks of a week. The time of this study is from the second half of February 2021 to the end of March 2021 and the evaluation of the program in The time periods of the first week of the first session, as a pre-test (filling in the questionnaires for the first time by the clients before the intervention) and the sixth week of the twelfth session, as a post-test (filling the questionnaires for the second time by the clients after the intervention) Took. After approving the proposal and obtaining the code of ethics, sampling was done by the method available in the departments of neurology, spinal cord injury, stroke of Rofeideh Rehabilitation Hospital and was performed within a period of one month and patients with inclusion criteria were included in the study. The objectives of the study were explained to the samples and the informed consent form was completed by the patients. Neurology, spinal cord injury, stroke were completed and quality of life in urinary incontinence and self-esteem were measured before the intervention. Urinary incontinence rehabilitation interventions in a two-dimensional intervention, in 7 30-minute sessions over 1 week Individual in-person and out-of-group training due to the prevalence of Covid-19 disease was taught and at the same time an educational booklet was provided to patients. Urinary incontinence To evaluate the correct implementation of urinary incontinence rehabilitation interventions, one session was held every week. Consultation, training and follow-up of the intervention was done by telephone with the researcher. If necessary, referrals were made to medical centers. At the end of the intervention and follow-up, 6 weeks after the last training session, post-test was performed and patients again completed the research questionnaires. Educational pamphlets and urinary incontinence rehabilitation interventions were provided to hospital wards for ethics. Session 1 (Week 1): Explain the intervention and its purpose, obtaining consent from clients, pre-test, filling out questionnaires for the first time by clients / Session 2 (Week 1): Anatomy and physiology training, urinary system and how it works Session 3 (Week 1): Familiarity with neurogenic bladder and its symptoms / Session 4 (Week 1): Training of urinary incontinence rehabilitation interventions (clean intermittent catheterization) by the researcher for clients, providing all training files through the group Virtual / Session 5 (first week): Behavior therapy (setting a specific time for urination according to the urination schedule, delaying the urination time as much as possible according to the urination schedule), providing all the training files through Virtual group / Session 6 (first week): Behavior therapy (diet), providing all the training files through the virtual group / Session 7 (first week): Tracking exercises, reviewing how clients do exercises and troubleshooting By sending video and video call online, answering clients' questions / Eighth session (second week): Examining how clients do exercises And troubleshooting by sending video and video call online, answering clients 'questions / Session 9 (third week): following up on exercises, reviewing how clients perform exercises and fixing problems by sending video and video calling online, answering clients' questions / Session 10 (Week 4): Follow up the exercises, check how the exercises are done by the clients and fix the problems by sending a video and online video call, answer the questions of the clients / Session 11 (Week 5): Follow the exercises, check how to do the exercises By clients and troubleshooting by sending video and video call online, answering clients 'questions / Twelfth session (sixth week): the last session answering clients' questions, post-test, refilling questionnaires for the second time by clients, their satisfaction with the performance This intervention, feedback</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Self esteem. Timepoint: Before the intervention and 6 weeks after starting the urinary incontinence rehabilitation program. Method of measurement: Rosenberg self esteem questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Urinary Incontinence Quality of Life Questionnaire. Timepoint: Before the intervention and 6 weeks after starting the urinary incontinence rehabilitation program. Method of measurement: Urinary Incontinence Quality of Life Questionnaire.</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>nothing</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2020-12-22</approval_date>
        <contact_name>University of Social Welfare and Rehabilitation Sciences</contact_name>
        <contact_address>Evin Blvd, Daneshjoo Ave.,Koodakyar Street, University of Social Welfare and Rehabilitation Sciences, Tehran,Iran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
