<?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>IRCT20211203053261N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-28</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>Overactive bladder treatment by Intravaginal injection of botulinum toxin A</public_title>
      <acronym></acronym>
      <scientific_title>Overactive bladder(OAB) treatment by Intravaginal injection of botulinum toxin A (Dysport): An effective outpatient procedure</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-12-22</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>50</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/60379</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Not randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.</study_design>
      <phase>3</phase>
      <hc_freetext>overactive bladder.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intravaginal Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: In this group, local anesthesia is applied on an outpatient basis; diluted lidocaine is injected in to the anterior wall of the vagina at the lithotomy position. The standard dose of Dysport (10 units per kilogram of patient's body weight ) is then diluted by injectable normal saline (1 cc per 100 units)  and injected into 10 points of the anterior vaginal wall, adjacent to the bladder, by an insulin syringe (very fine 31 gauge needle). Foley catheter is not necessary at the end of procedure. Intervention 2: Control group: Intravesical Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: After regional or general anesthesia, cystoscopy and bladder washing are performed at the lithotomy position  . The appropriate dose of Dysport, equivalent to 10 units per kilogram of patient weight (maximum 1000 units), is diluted with injectable normal saline (1 cc per 100 units). The final solution is injected into 20 different points of detrusor muscle by a special 22 gauge bladder injection needle (BoNee ;Coloplast, Humlebaek, Denmark) through cystoscope, and Foley catheter is fixed at the end of the procedure.</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 The information will be entered as code in SPSS software and the analysis results will be published as a final report and article</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Maede Mohseni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urology and Nephrology Research Center, Shahid Beheshti Hospital, Eram Boulevard, Hamadan,Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517953371</zip>
        <telephone>+98 81 3838 0704</telephone>
        <email>mao.mohseni@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Maede Mohseni</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Urology and Nephrology Research Center, Shahid Beheshti Hospital, Eram Boulevard, Hamadan,Iran</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>6517953371</zip>
        <telephone>+98 81 3838 0704</telephone>
        <email>mao.mohseni@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Adult women with overactive bladder who have not responded to initial medical treatment</inclusion_criteria>
      <agemin>18 years</agemin>
      <agemax>no limit</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Age under 18 years
patients with neurogenic bladder  (known cases of neurological defects)
Active UTI
Women with intact Hymen</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>Treatment - Surgery</i_code>
      <i_code>Treatment - Surgery</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intravaginal Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: In this group, local anesthesia is applied on an outpatient basis; diluted lidocaine is injected in to the anterior wall of the vagina at the lithotomy position. The standard dose of Dysport (10 units per kilogram of patient's body weight ) is then diluted by injectable normal saline (1 cc per 100 units)  and injected into 10 points of the anterior vaginal wall, adjacent to the bladder, by an insulin syringe (very fine 31 gauge needle). Foley catheter is not necessary at the end of procedure.</i_keyword>
      <i_keyword>Control group: Intravesical Dysport (Abobotulinum toxin A, Ipsen Biop- harmaceuticals, Pharma, Germany) injection: After regional or general anesthesia, cystoscopy and bladder washing are performed at the lithotomy position  . The appropriate dose of Dysport, equivalent to 10 units per kilogram of patient weight (maximum 1000 units), is diluted with injectable normal saline (1 cc per 100 units). The final solution is injected into 20 different points of detrusor muscle by a special 22 gauge bladder injection needle (BoNee ;Coloplast, Humlebaek, Denmark) through cystoscope, and Foley catheter is fixed at the end of the procedure.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>ICIQ-OAB symptom score. Timepoint: Before and 4 weeks after intervention. Method of measurement: Validated questionnaire.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Pain severity. Timepoint: Before and 4 weeks after intervention. Method of measurement: VAS score.</sec_outcome>
      <sec_outcome>Incidence of gross hematuria. Timepoint: Within a week after the intervention. Method of measurement: View Foley catheter / Ask the patient.</sec_outcome>
      <sec_outcome>Incidence of dysuria. Timepoint: Within a week after the intervention. Method of measurement: Ask the patient.</sec_outcome>
      <sec_outcome>Incidence of UTI. Timepoint: Within a week after the intervention. Method of measurement: Urine culture.</sec_outcome>
      <sec_outcome>Incidence of urinary retention and need for CIC. Timepoint: Within a week after the intervention. Method of measurement: Ultrasonography and ask the patient.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-10-02</approval_date>
        <contact_name>Ethics committee of urology and nephrology research center, Shahid Beheshti university of medical sc</contact_name>
        <contact_address>No 103, Boostan 9, Pasdaran AV, Tehran Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
