<?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>IRCT20210809052123N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2022-05-08</date_registration>
      <primary_sponsor>Shahid Beheshti University of Medical Sciences</primary_sponsor>
      <public_title>The effect of manual therapy on erectile dysfunction</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the effect of pelvic floor myofascial release and  Pelvic floor training on treatment of  male erectile dysfunction in post adenectomy and radical prostatectomy</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2022-05-06</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>80</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/61833</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients were divided into four random groups using a random number constructor. The randomization method is simple and done individually. In order to randomize the statistics, the names of the people are entered in Excel software, then random numbers are assigned to each person using the Rand function. These numbers are then sorted from small to large using software sorting, which disrupts the order of the initial list and randomizes how people are positioned. Then, the first 20 people are considered for the treatment group of adenectomy patients, the second 20 people are considered for the control group of adenectomy surgery, the third 20 people are considered for the treatment group of radical patients and the fourth 20 people are considered for the control group of radical patients. Randomization of patients was done by a statistical consultant and the groups will be determined based on number 1 for the treatment group of adenectomy patients, number 2 for the control group of adenectomy surgery, number 3 for the treatment group of radical patients and number 4 for the control group of radical patients, Blinding description: 1- Participants: In the case group, the application of the manual technique is performed in a real way, while in the control group, only a superficial touch is performed and the therapeutic exercise component is performed in the same way in both.
2- Data Analyzer: The data analyzer will use code to analyze the data in such a way that it is unaware of its content.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Erectile dysfunction.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: Intervention group 1: Adenectomy surgery patients who will undergo manual therapy and exercise therapy. In these patients, the muscles of the ischiocaverenus and bulbospangius are released by massage. The therapist performs this technique with his index finger. The massage is performed for ten minutes. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes. Intervention 2: Intervention group: Intervention group 2: Radical surgery patients who will undergo manual therapy and exercise therapy. In these patients, the muscles of the ischiocaverenus and bulbospangius are released by massage. The therapist performs this technique with his index finger. The massage is performed for ten minutes. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes. Intervention 3: Control group: Control group1 : Adenectomy surgery patients who will undergo exercise therapy.  Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes. Intervention 4: Control group: Control group1 : Radical surgery patients who will undergo exercise therapy.  Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.</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:
All data is shared after people are not identified and the article is published.

When:
The access period will start 2 months after the results are published

To whom:
It will be available to researchers working in academic and scientific institutions

Conditions:
There is no specific condition

Where to obtain:
Dr. Mehdi Afshar Safavi
Phone number +989105001656
No. 11/1 , Pejman 1 , Ebadi 47, Mashhad,

How to obtain:
The applicant can submit his application via email. 
mahdi3068@gmail.com

Comments:
</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Mahdi Afshar Safavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 11/1 . pejman 1 , ebadi 47 , mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9193798711</zip>
        <telephone>+98 51 3225 7030</telephone>
        <email>mahdi3068@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Mahdi Afshar Safavi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>no 11/1 , pejman 1 , ebadi 47 . mashhad</address>
        <city>Mashhad</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9193798711</zip>
        <telephone>+98 51 3225 7030</telephone>
        <email>mahdi3068@gmail.com</email>
        <affiliation>Shahid Beheshti University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Confirmation of the absence of a secondary erection to prostate surgery by a physician
Patients operated by retropubic technique with both adenectomy and radical methods
Being married
Age range between 45 to 60 years</inclusion_criteria>
      <agemin>45 years</agemin>
      <agemax>60 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Taking erectile drugs such as taladafil and sildenafil
Mental problems such as depression</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N52.9</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Male erectile dysfunction, unspecified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: Intervention group 1: Adenectomy surgery patients who will undergo manual therapy and exercise therapy. In these patients, the muscles of the ischiocaverenus and bulbospangius are released by massage. The therapist performs this technique with his index finger. The massage is performed for ten minutes. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.</i_keyword>
      <i_keyword>Intervention group: Intervention group 2: Radical surgery patients who will undergo manual therapy and exercise therapy. In these patients, the muscles of the ischiocaverenus and bulbospangius are released by massage. The therapist performs this technique with his index finger. The massage is performed for ten minutes. Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.</i_keyword>
      <i_keyword>Control group: Control group1 : Adenectomy surgery patients who will undergo exercise therapy.  Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.</i_keyword>
      <i_keyword>Control group: Control group1 : Radical surgery patients who will undergo exercise therapy.  Patients will be treated for ten sessions, three sessions per week. Exercise therapy in these patients is such that the individual is instructed to selectively contract his  ischiocaverenus muscle and hold this contraction for 7 seconds. Then rest for 7 seconds. The person is also taught how to lift the testicles in front of a mirror. he dose this exercise for ten minutes.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Erection hardness. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: Erection hardness score.</prim_outcome>
      <prim_outcome>Erection index. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: International index of erectile function Questionnaire.</prim_outcome>
      <prim_outcome>Maximum thickness of Ischiocavernus. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by two-dimensional ultrasound.</prim_outcome>
      <prim_outcome>Maximum thickness of bulbouspongesios. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by two-dimensional ultrasound.</prim_outcome>
      <prim_outcome>Area of Ischiocavernus. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by two-dimensional ultrasound.</prim_outcome>
      <prim_outcome>Area of bulbouspongesios. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by two-dimensional ultrasound.</prim_outcome>
      <prim_outcome>Maximum cavernosal systolic velocity. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by color ultrasound.</prim_outcome>
      <prim_outcome>Minimum diastolic velocity of cavernosal artery. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by color ultrasound.</prim_outcome>
      <prim_outcome>Cavernosal artery diameter. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by color ultrasound.</prim_outcome>
      <prim_outcome>Maximum blood velocity in the posterior vein. Timepoint: Outcome will be measured at both the beginning and end of treatment. Method of measurement: measured by color ultrasound.</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>Shahid Beheshti University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2022-01-09</approval_date>
        <contact_name>Ethics Committee of Shahid Beheshti University of Medical Sciences</contact_name>
        <contact_address>No. 11/1 , Pejman 1,  Ebadi 47 , Ayatollah Ebadi St , Mashhad Tehran Tehran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
