<?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>IRCT20180503039517N16</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2026-10-30</date_registration>
      <primary_sponsor>Islamic Azad University</primary_sponsor>
      <public_title>The effect of Kegel exercises combined with abdominal exercises on middle-aged women with urinary incontinence.</public_title>
      <acronym></acronym>
      <scientific_title>The effect of Kegel exercises combined with abdominal exercises on symptom severity, quality of life, sexual satisfaction, and sleep quality in middle-aged women with urinary incontinence.</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2026-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>60</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/91363</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 60 middle-aged women with urinary incontinence will be selected by convenience sampling method. A simple randomization method will be employed, with the individual as the unit of randomization. To generate the random sequence, participants will be numbered sequentially upon entry, and each will be assigned with an equal probability to one of the three groups (two intervention groups and one control group) using a random number table (or random number generator software). To ensure allocation concealment, the group assignment for each participant will be placed in separate, numbered, and sequentially sealed envelopes. These envelopes will be opened by an independent person (other than the researcher) only after the final registration and obtaining written informed consent from each participant, thereby minimizing allocation bias, Blinding description: In this research, the persons responsible for evaluating and collecting information, as well as the data analyst, are unaware of the type of intervention and the participants in the research groups.</study_design>
      <phase>N/A</phase>
      <hc_freetext>Urinary incontinence.</hc_freetext>
      <i_freetext>Intervention 1: Intervention group: 1: Kegel exercises: The exercises in this group include a series of pelvic floor muscle contractions for 6 to 8 seconds and a 5-second rest, which will be performed in different positions: lying down, sitting, and standing. These exercises will be performed every day of the week (15 minutes each time) for 12 consecutive weeks. Intervention 2: Intervention group: 2: Kegel exercises with abdominal exercises: This group will perform Kegel exercises according to the program of Group 1. In addition, for the abdominal exercises, participants will be instructed to contract their abdominal muscles by pulling their navel towards their spine in a lying position and contracting them strongly and statically, then try to touch the farthest point of their feet with their fingertips.</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>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is Data will be made available upon formal request.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Fahimeh Adibsaber</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan Blv</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 4073</telephone>
        <email>adibsaberfahimeh@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Fahimeh Adibsaber</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Lakan Blv</address>
        <city>Rasht</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>4147654919</zip>
        <telephone>+98 13 3342 4070</telephone>
        <email>adibsaberfahimeh@iau.ac.ir</email>
        <affiliation>Islamic Azad University</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age range 40 to 55 years
Urgent urinary incontinence diagnosis by an obstetrician-gynecologist or urologist
Consent to participate in research
6 months or more have passed since the previous birth</inclusion_criteria>
      <agemin>40 years</agemin>
      <agemax>55 years</agemax>
      <gender>Female</gender>
      <exclusion_criteria>Having a urinary tract infection
Use of common drug treatments and physiotherapy treatment
Pregnancy
Having surgery related to urinary incontinence
Having co-morbid physical and mental illnesses such as cancer, heart disease, schizophrenia, and physical disabilities</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>R32</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>stress incontinence and other specified urinary incontinence</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Other</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Intervention group: 1: Kegel exercises: The exercises in this group include a series of pelvic floor muscle contractions for 6 to 8 seconds and a 5-second rest, which will be performed in different positions: lying down, sitting, and standing. These exercises will be performed every day of the week (15 minutes each time) for 12 consecutive weeks.</i_keyword>
      <i_keyword>Intervention group: 2: Kegel exercises with abdominal exercises: This group will perform Kegel exercises according to the program of Group 1. In addition, for the abdominal exercises, participants will be instructed to contract their abdominal muscles by pulling their navel towards their spine in a lying position and contracting them strongly and statically, then try to touch the farthest point of their feet with their fingertips.</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>Severe urinary incontinence symptoms. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: It will be measured through the Urinary Incontinence Questionnaire - Short Form of Avery et al. (2004).</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>Waist to hip ratio. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: To measure waist circumference, the narrowest area between the last rib and the upper part of the pelvis and the hip circumference will be measured with a tape measure and as the largest circumference around the hips.</sec_outcome>
      <sec_outcome>Psychological well-being. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: The Riff Psychological Well-Being Questionnaire (2002) will be used.</sec_outcome>
      <sec_outcome>Sexual function. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: The Rosen (2000) Female Sexual Function Questionnaire will be used.</sec_outcome>
      <sec_outcome>Quality of life. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: Quality of life will be measured through the questionnaire for people with urinary incontinence by Wegener, Patrick, Bavendam, Marty, and Bushing (1996).</sec_outcome>
      <sec_outcome>Sleep quality. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: It will be measured through the Pittsburgh Sleep Quality Questionnaire by Boyce et al. (1989).</sec_outcome>
      <sec_outcome>Body composition. Timepoint: 48 hours before the intervention and 48 hours after 12 weeks of intervention. Method of measurement: For each individual, the body mass index (BMI) will be calculated from the ratio of weight in kilograms to the square of height in meters.</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>Islamic Azad University</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2026-01-19</approval_date>
        <contact_name>Research Ethics Committee of Islamic Azad University- Babol Branch</contact_name>
        <contact_address>Babol Azad University, Rahimi Highway, Babol Babol Mazandaran Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
