<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488068</url>
  </required_header>
  <id_info>
    <org_study_id>F3455-P</org_study_id>
    <nct_id>NCT04488068</nct_id>
  </id_info>
  <brief_title>Transpelvic Magnetic Stimulation to Improve Urogenital Function</brief_title>
  <official_title>Feasibility Testing of Transpelvic Magnetic Stimulation as a Novel Intervention toImprove Urogenital Function in Prostate Cancer Survivors</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      After recruitment, 20 male patients will be assigned 1:1 to either age-matched control (G1:&#xD;
      sham) or age-matched intervention (G2: pelvic magnetic stimulation; TPMS) groups using&#xD;
      computer-generated process, and baseline parameters will be established. All patients will be&#xD;
      instructed by the investigators to perform standard of care pelvic floor exercise for the&#xD;
      duration of the study. In addition, G2 patients will receive TPMS, while G1 patients will&#xD;
      undergo sham treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The investigators will use a custom TPMS device that targets pelvic muscles. The&#xD;
      investigators will apply low amplitude (5%) TPMS to improve blood flow, then high amplitude&#xD;
      (30-50%) to strengthen pelvic muscles. The treatment regimen will involve two 20-minute&#xD;
      sessions/visit and 2 -visits per week for 12-weeks (final monitoring at 24 weeks). TPMS will&#xD;
      be administered by a trained clinical coordinator under the supervision of a urologist.&#xD;
      Symptom scores and hemodynamic changes will be evaluated monthly. MRI for assessing muscle&#xD;
      thickness will be performed in the beginning (before TPMS) and at the end (after TPMS) of the&#xD;
      study. The investigators will assess functional improvements using symptom scores.&#xD;
      Morphological changes will be determined by MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2020</start_date>
  <completion_date type="Actual">September 30, 2022</completion_date>
  <primary_completion_date type="Actual">August 11, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Intervention to prevent prostate cancer surgery related urological issues</intervention_model_description>
    <primary_purpose>Prevention</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Improvements in sexual function change</measure>
    <time_frame>At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy</time_frame>
    <description>Primary outcome measure will be to determine improvements in male sexual (erectile) function after magnetic stimulation therapy.&#xD;
The objective measure for erectile function will be the International Index of Erectile Function (IIEF), a validated, 5-item symptom-subjective score. These five items focus on male erectile function. Response options are based on rating scales from 1 to 5 and the responses are added to form a total IIEF-5 score from 5 to 25. Lower scores indicate poor sexual function and higher scores after therapy will indicate improvement.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in number of pads used as a measure of Improvements in continence function</measure>
    <time_frame>At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy</time_frame>
    <description>The first objective measure for urinary incontinence (UI) change will be the number of pads used in 24-hours as an index of urine leakage. Higher number of pad use will indicate severe UI and lower number pad use after therapy will indicate improvement.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Improvements in penile blood flow change</measure>
    <time_frame>Penile blood flow (mm/sec) will be measured at baseline and at 4, 8, 12, 13 and 24 weeks post- treatment.</time_frame>
    <description>Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvements in pelvic muscle thickness change</measure>
    <time_frame>Muscle thickness (mm) will be measured at baseline and at 13 weeks post- treatment.</time_frame>
    <description>Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Pad weight as a measure of Improvements in continence function</measure>
    <time_frame>At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy</time_frame>
    <description>The second objective measure for urinary incontinence (UI) change will be the total weight of the pads used in 24-hours as an index of urine leakage. Higher number of pad weight will indicate severe UI and lower number pad use after therapy will indicate improvement.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in urinary symptom score as a measure of Improvements in continence function</measure>
    <time_frame>At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy</time_frame>
    <description>The third objective measure for urinary incontinence (UI) change will be the change in urinary symptom scores. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score (scores range: 0-21), a score which assesses the symptoms and effect of UI on quality of life. Higher scores will indicate severe UI and lower scores after therapy will indicate improvement.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Prostate Cancer</condition>
  <condition>Erectile Dysfunction</condition>
  <arm_group>
    <arm_group_label>Magnetic Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will be subjected to TPMS.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sham TPMS</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will be subjected to sham TPMS</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Sham Magnetic stimulation</intervention_name>
    <description>Sham Magnetic stimulation for comparison.</description>
    <arm_group_label>Magnetic Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  men over 50 years old who are enrolled for prostate surgery,&#xD;
&#xD;
          -  have serum testosterone within normal limits, and&#xD;
&#xD;
          -  are without prior bilateral orchiectomy, chemotherapy, external radiotherapy,&#xD;
             brachytherapy, surgical, or other ablative therapy for prostate cancer.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with ED caused by psychological, neurogenic (after non-nerve sparing prostate&#xD;
             surgery), or hormonal disorders,&#xD;
&#xD;
          -  patients with genital abnormalities precluding intercourse, prior penile implantation,&#xD;
             ongoing erectile aid use, or use of nitrate medications.&#xD;
&#xD;
          -  Androgen suppression within the past 6 months or as part of protocol-specified&#xD;
             radiotherapy or brachytherapy will be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mahadevan R. Rajasekaran, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 27, 2020</study_first_posted>
  <last_update_submitted>November 4, 2022</last_update_submitted>
  <last_update_submitted_qc>November 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urinary incontinence</keyword>
  <keyword>hemodynamics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Erectile Dysfunction</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>July 23, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT04488068/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488068
org study id: F3455-P
nct id: NCT04488068
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
After recruitment, 20 male patients will be assigned 1:1 to either age-matched control (G1:
      sham) or age-matched intervention (G2: pelvic magnetic stimulation; TPMS) groups using
      computer-generated process, and baseline parameters will be established. All patients will be
      instructed by the investigators to perform standard of care pelvic floor exercise for the
      duration of the study. In addition, G2 patients will receive TPMS, while G1 patients will
      undergo sham treatment.
The investigators will use a custom TPMS device that targets pelvic muscles. The
      investigators will apply low amplitude (5%) TPMS to improve blood flow, then high amplitude
      (30-50%) to strengthen pelvic muscles. The treatment regimen will involve two 20-minute
      sessions/visit and 2 -visits per week for 12-weeks (final monitoring at 24 weeks). TPMS will
      be administered by a trained clinical coordinator under the supervision of a urologist.
      Symptom scores and hemodynamic changes will be evaluated monthly. MRI for assessing muscle
      thickness will be performed in the beginning (before TPMS) and at the end (after TPMS) of the
      study. The investigators will assess functional improvements using symptom scores.
      Morphological changes will be determined by MRI.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Intervention to prevent prostate cancer surgery related urological issues
primary purpose: Prevention
masking: None (Open Label)
measure: Improvements in sexual function change
time frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
description: Primary outcome measure will be to determine improvements in male sexual (erectile) function after magnetic stimulation therapy.
The objective measure for erectile function will be the International Index of Erectile Function (IIEF), a validated, 5-item symptom-subjective score. These five items focus on male erectile function. Response options are based on rating scales from 1 to 5 and the responses are added to form a total IIEF-5 score from 5 to 25. Lower scores indicate poor sexual function and higher scores after therapy will indicate improvement.
measure: Change in number of pads used as a measure of Improvements in continence function
time frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
description: The first objective measure for urinary incontinence (UI) change will be the number of pads used in 24-hours as an index of urine leakage. Higher number of pad use will indicate severe UI and lower number pad use after therapy will indicate improvement.
measure: Improvements in penile blood flow change
time frame: Penile blood flow (mm/sec) will be measured at baseline and at 4, 8, 12, 13 and 24 weeks post- treatment.
description: Penile blood flow will be measured as peak systolic velocity (mm/sec) using laser Doppler method.
measure: Improvements in pelvic muscle thickness change
time frame: Muscle thickness (mm) will be measured at baseline and at 13 weeks post- treatment.
description: Muscle thickness (mm) will be measured by anatomical MRI and quantified using imaging software such as Amira.
measure: Change in Pad weight as a measure of Improvements in continence function
time frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
description: The second objective measure for urinary incontinence (UI) change will be the total weight of the pads used in 24-hours as an index of urine leakage. Higher number of pad weight will indicate severe UI and lower number pad use after therapy will indicate improvement.
measure: Change in urinary symptom score as a measure of Improvements in continence function
time frame: At baseline and at 4, 8, 12, 13 and 24 weeks 24-weeks post therapy
description: The third objective measure for urinary incontinence (UI) change will be the change in urinary symptom scores. The investigators will use International Consultation of Incontinence Questionnaire (ICIQ)-symptom score (scores range: 0-21), a score which assesses the symptoms and effect of UI on quality of life. Higher scores will indicate severe UI and lower scores after therapy will indicate improvement.
arm group label: Magnetic Stimulation
arm group type: Experimental
description: Patients will be subjected to TPMS.
arm group label: Sham TPMS
arm group type: No Intervention
description: Patients will be subjected to sham TPMS
intervention type: Procedure
intervention name: Sham Magnetic stimulation
description: Sham Magnetic stimulation for comparison.
arm group label: Magnetic Stimulation
criteria: 
gender: Male
gender based: Yes
gender description: Our proposal is aimed at preventing sexual dysfunction and urinary incontinence in prostate cancer survivors, a gender specific cancer.
minimum age: 50 Years
maximum age: 80 Years
healthy volunteers: No
last name: Mahadevan R. Rajasekaran, PhD
role: Principal Investigator
affiliation: VA San Diego Healthcare System, San Diego, CA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Prostatic Neoplasms
mesh term: Erectile Dysfunction
sharing ipd: No
provided document: 