<?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>IRCT20260915071067N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-09-16</date_registration>
      <primary_sponsor>Hamedan University of Medical Sciences</primary_sponsor>
      <public_title>Effect of Bladder Training and Kegel Exercises on Urinary Incontinence and Quality of Life After Transurethral Resection of the Prostate</public_title>
      <acronym></acronym>
      <scientific_title>Comparison of the Effectiveness of Bladder Training and Pelvic Floor Muscle Exercises (Kegel Exercises) with Usual Care on Urinary Incontinence and Quality of Life in Men Candidates for Transurethral Resection of the Prostate (TURP)</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-10-07</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>90</target_size>
      <recruitment_status>Recruiting</recruitment_status>
      <url>https://irct.ir/trial/93363</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Other design features: This study is a randomized clinical trial with a parallel three-group design. After confirming eligibility criteria and obtaining informed consent, participants will be randomly allocated into three groups: bladder training group, Kegel exercise group, and control group. The interventions will start one week before Transurethral Resection of the Prostate (TURP) surgery and will continue for eight weeks after surgery. The primary outcomes, including urinary incontinence and quality of life related to urinary problems, will be assessed before the intervention and after completion of the intervention period, Randomization description: Randomization in this study will be performed using simple randomization at the individual level. After selecting eligible participants and obtaining written informed consent, each participant will be assigned a number from 1 to 90. The assigned numbers will be placed in a bag, and participants will be randomly allocated without replacement into three groups of 30 participants: the bladder training group, the Kegel exercise group, and the control group. Stratified or cluster randomization will not be used in this study. The random sequence will be generated by a random drawing method. For allocation concealment, the assigned numbers will be kept in the bag until the final allocation, and each participant's group assignment will be determined only after confirmed enrollment in the study.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Benign Prostatic Hyperplasia.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group 1: Participants in this group will receive bladder training in addition to usual care. Bladder training includes scheduled voiding, urgency control techniques, limitation of bladder irritant fluid intake, and recording urinary patterns. This intervention will start one week before transurethral resection of the prostate and will continue for eight weeks after surgery. Intervention 2: Intervention group 2: Participants in this group will receive pelvic floor muscle exercises (Kegel exercises) in addition to usual care. The intervention includes contraction and relaxation of pelvic floor muscles performed 40 times daily. Patients will receive instructions on correct performance of the exercises. The intervention will start one week before transurethral resection of the prostate and will continue for eight weeks after surgery. Intervention 3: Control group: Participants in this group will receive routine care and education before and after transurethral resection of the prostate. This group will not receive any specific training in bladder training or pelvic floor muscle exercises.</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 Due to maintaining participants' confidentiality and adhering to research ethics principles, individual participant data will not be publicly shared.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Seyed Ali Rasooli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3323 9840</telephone>
        <email>alirasoolix6@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Seyed Ali Rasooli</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan</address>
        <city>Hamadan</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>۶۵۱۷۸۳۸۷۳۶</zip>
        <telephone>+98 81 3323 9840</telephone>
        <email>alirasoolix6@gmail.com</email>
        <affiliation>Hamedan University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Men who are candidates for Transurethral Resection of the Prostate (TURP).
Patients undergoing TURP surgery according to the urologist's decision.
Age between 40 and 80 years.
Having primary school education or higher.
Willingness to participate in the study and signing the informed consent form.
No history of previous pelvic surgery.
No diagnosis of prostate cancer based on postoperative pathology results.
No previous training in bladder training or Kegel exercises before entering the study.
No cognitive impairment.
No urinary incontinence caused by underlying diseases such as diabetes or urinary tract infections.</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>80 years</agemax>
      <gender>Male</gender>
      <exclusion_criteria>Diagnosis of prostate cancer based on pathology results
History of previous pelvic surgery
Previous training in bladder training or Kegel exercises
Presence of cognitive impairment
Presence of urinary incontinence caused by conditions such as diabetes or urinary tract infection</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>N40</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>Benign prostatic hyperplasia</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Rehabilitation</i_code>
      <i_code>Rehabilitation</i_code>
      <i_code>N/A</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group 1: Participants in this group will receive bladder training in addition to usual care. Bladder training includes scheduled voiding, urgency control techniques, limitation of bladder irritant fluid intake, and recording urinary patterns. This intervention will start one week before transurethral resection of the prostate and will continue for eight weeks after surgery.</i_keyword>
      <i_keyword>Intervention group 2: Participants in this group will receive pelvic floor muscle exercises (Kegel exercises) in addition to usual care. The intervention includes contraction and relaxation of pelvic floor muscles performed 40 times daily. Patients will receive instructions on correct performance of the exercises. The intervention will start one week before transurethral resection of the prostate and will continue for eight weeks after surgery.</i_keyword>
      <i_keyword>Control group: Participants in this group will receive routine care and education before and after transurethral resection of the prostate. This group will not receive any specific training in bladder training or pelvic floor muscle exercises.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Urinary incontinence severity. Timepoint: Measurement of urinary incontinence severity before the intervention and two months after transurethral resection of the prostate. Method of measurement: International Consultation on Incontinence Questionnaire short form.</prim_outcome>
      <prim_outcome>Quality of life related to urinary symptoms. Timepoint: Measurement of quality of life related to urinary symptoms before the intervention and two months after transurethral resection of the prostate. Method of measurement: Lower urinary tract symptoms quality of life questionnaire.</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>Hamedan University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-09-12</approval_date>
        <contact_name>Ethics Committee of Hamadan University of Medical Sciences</contact_name>
        <contact_address>Central Office of Hamadan University of Medical Sciences, Shahid Fahmideh Boulevard, Pajouhesh Square, Hamadan Hamadan Hamadan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
