<?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>IRCT2016061828486N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2017-03-12</date_registration>
      <primary_sponsor>Vice Chancellor for research of Tehran  University of Medical Sciences</primary_sponsor>
      <public_title>Effect of physiotherapy and botulinum toxin injection in treatment of vaginismus</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of therapeutic efficacy of physiotherapy and botulinum toxin injection in treatment of vaginismus and comparison of sexual function of  them</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2017-02-08</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>74</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/23111</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: Table of random numbers.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Psychogenic vaginismus.</hc_freetext>
      <i_freetext>Intervention 1: intervention group 1:injection of botulinum toxin (dysport ):500 unit is diluted in 1.5 cc N/S.150-400 U disport was equally injected in the puborectalis muscles ,3 points on each side with 23 needle.in severe desease before injection 1_5 mg midazolam and 50-150 mg phentanyle are used for sedation.during treatment oxygen and pulse oximetry is done.the initial dose is 150-200 u and may gradually increase till 400 unit to prevent side effect.after injection the paitent is discharged. Intervention 2: Control group:Physiotherapy:  relaxation exercises, biofeedback, desensitization and focus sensory (sensation focus) is used during weekly meetings.Patients initially trained in pelvic floor anatomy . At each visit, pelvic floor muscle massage is done  in lithotomy position under infrared light to increase blood flow by therapist and exercises to relax the pelvic floor muscles and breathing exercises will be taught to do at home.Then, when the patient is admitted vaginal examination,The therapist began to gradually vaginal penetration with a finger and When patients  tolerate a fingerو vaginal tampon used for 5 hours to cause further relaxation.This practice will be repeated up to three times per dey at home.At this time, in addition to tampons , vaginal electrodes tense and frequency waves used for analgesic.Sensation focus technique done by the partner at home,Where massage the entire body except breast and genital areas without penetration causes the patient feel peace. Therapy sessions along with home exercise therapy in patients continue to recover. Average of meeting are 10 sessions.</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></results_IPD_plan>
      <results_IPD_description></results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Tahereh Eftekhar dr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini hospital,Valiasr hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6643 8633</telephone>
        <email>eftekhart@sina.tums.ac.ir</email>
        <affiliation>Tehran University Of Medical sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Tahereh Eftekhar dr</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Emam Khomeini Hospital, Valiasr Hospital</address>
        <city>Tehran</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip></zip>
        <telephone>+98 21 6643 8633</telephone>
        <email>eftekhart@sina.tums.ac.ir</email>
        <affiliation>Tehran University Of Medical sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>inclusion criteria:20-40 years old nonpregnant women of sexual health and women clinics of emem khomeini hospital  which have grade 3 or 4 vaginismus on lamont grading; they dont have any botulinum toxin containdication( albumin and botulinum or injectable component alergy; infection of injection site;  pregnancy; nerve and muscle desease such as Myasthenia Gravis and Lambert Eaton syndrome; coagulation disorders;  anticoagulant drugs &#13;
exclusion criteria:pregnant women; pregnancy planing; botulinum contraindication; poor cooperation; secondary vaginismus; Vvlvdynya; skin disorders of vulve or Perineum; anal fissure; urinary or deficatory disorders; infection of injection site; previous botulinum treatment; previous physiotherapy</inclusion_criteria>
      <agemin>20 years</agemin>
      <agemax>40 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria></exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>F52.5</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Spasm of the pelvic floor muscles that surround the vagina, causing occlusion of the vaginal opening. Penile entry is either impossible or painful</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Drugs</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>intervention group 1:injection of botulinum toxin (dysport ):500 unit is diluted in 1.5 cc N/S.150-400 U disport was equally injected in the puborectalis muscles ,3 points on each side with 23 needle.in severe desease before injection 1_5 mg midazolam and 50-150 mg phentanyle are used for sedation.during treatment oxygen and pulse oximetry is done.the initial dose is 150-200 u and may gradually increase till 400 unit to prevent side effect.after injection the paitent is discharged.</i_keyword>
      <i_keyword>Control group:Physiotherapy:  relaxation exercises, biofeedback, desensitization and focus sensory (sensation focus) is used during weekly meetings.Patients initially trained in pelvic floor anatomy . At each visit, pelvic floor muscle massage is done  in lithotomy position under infrared light to increase blood flow by therapist and exercises to relax the pelvic floor muscles and breathing exercises will be taught to do at home.Then, when the patient is admitted vaginal examination,The therapist began to gradually vaginal penetration with a finger and When patients  tolerate a fingerو vaginal tampon used for 5 hours to cause further relaxation.This practice will be repeated up to three times per dey at home.At this time, in addition to tampons , vaginal electrodes tense and frequency waves used for analgesic.Sensation focus technique done by the partner at home,Where massage the entire body except breast and genital areas without penetration causes the patient feel peace. Therapy sessions along with home exercise therapy in patients continue to recover. Average of meeting are 10 sessions.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Libido. Timepoint: before and 1week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).</prim_outcome>
      <prim_outcome>Arousal. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).</prim_outcome>
      <prim_outcome>Lubrication. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).</prim_outcome>
      <prim_outcome>Orgasm. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).</prim_outcome>
      <prim_outcome>Sexual Satisfaction. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).</prim_outcome>
      <prim_outcome>Pain. Timepoint: before and 1 week after Treatment. Method of measurement: Demographic questionaries and women sexual function questionaries(FSFI).</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>Vice Chancellor for research of Tehran  University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2017-02-07</approval_date>
        <contact_name>Ethics committee of Tehran University of Medical Sciences</contact_name>
        <contact_address>Tehran medical University Tehran  Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
