<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/NCT03238716</url>
  </required_header>
  <id_info>
    <org_study_id>AAMT0015</org_study_id>
    <nct_id>NCT03238716</nct_id>
  </id_info>
  <brief_title>Neuromuscular Re-eduaction, Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Exercise for Stress Urinary Incontinence</brief_title>
  <official_title>Neuromuscular Re-education, Impairment-based Exercise and Electric Dry Needling vs. Neuromuscular Re-education and Impairment-based Exercise for Stress Urinary Incontinence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Alabama Physical Therapy &amp; Acupuncture</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidad Rey Juan Carlos</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Alabama Physical Therapy &amp; Acupuncture</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to compare two different approaches for treating patients&#xD;
      with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and&#xD;
      electric dry needling versus neuromuscular re-education and impairment-based exercise.&#xD;
      Physical therapists commonly use all of these techniques to treat stress urinary&#xD;
      incontinence. This study is attempting to find out if one treatment strategy is more&#xD;
      effective than the other.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with stress urinary incontinence will be randomized to receive 2 treatment sessions&#xD;
      per week for up to 6 weeks (8-12 sessions total) of either: (1) neuromuscular re-education,&#xD;
      impairment-based exercise and electric dry needling (2) neuromuscular re-education and&#xD;
      impairment-based exercise&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inability to recruit an adequate number of patients with stress urinary incontinence (based on&#xD;
    inclusion / exclusion criteria) to participate in the study&#xD;
  </why_stopped>
  <start_date type="Actual">July 1, 2017</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">March 1, 2019</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incontinence Impact Questionnaire - Short Form IIQ-7</measure>
    <time_frame>baseline, 6 weeks, 3 months</time_frame>
    <description>7 questions, each worth 0-3 points. The average score of items responded to is calculated, then multiplied by 33 1/3 to put the scores on a scale of 0 to 100. High scores indicate greater impact of incontinence.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global Rating of Change Scale</measure>
    <time_frame>6 weeks, 3 months</time_frame>
    <description>15 point self-report scale (-7 to 7). High rating indicates a greater impact of change</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urinary pad per day usage</measure>
    <time_frame>baseline, 6 weeks, 3 months</time_frame>
    <description>Number of urinary pads that the patient requires per day secondary to stress urinary incontinence</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Urogenital Distress Inventory</measure>
    <time_frame>baseline, 6 weeks, 3 months</time_frame>
    <description>6 questions, each worth 0-3 points. The raw score is divided by 6 then multiplied by 25 for the total score. High scores indicate more distress due to bladder symptoms.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Stress Urinary Incontinence</condition>
  <arm_group>
    <arm_group_label>Electric DN, NM Re-ed, Exercise</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NM Re-ed and Exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Electric DN</intervention_name>
    <description>Dry needling with electric stimulation to the erector spine and paraspinal muscles in the lumbar / sacral region and tibialis anterior / posterior. Dry needling with electric stimulation of peri-neural tissue associated with lumbar / sacral nerve roots, pudendal nerve and posterior tibial nerve. 8-12 treatment sessions over 6 weeks.</description>
    <arm_group_label>Electric DN, NM Re-ed, Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>NM Re-ed</intervention_name>
    <description>sEMG targeting type I slow-twitch fibers and type II fast-twitch fibers. Type I fibers maintain continuous muscle activity over prolonged periods of time; therefore, training of type I fibers will be achieved through endurance and repetition training of the pelvic floor muscles. Type II fibers are recruited during sudden increases in intra-abdominal pressure, and these fibers will be recruited with &quot;The Knack&quot; training. The Knack is a term created to use rhythm or timing to the pelvic floor. Neuromuscular re-education will be performed during the first treatment, but it will be performed &quot;as needed&quot; on subsequent treatments.</description>
    <arm_group_label>Electric DN, NM Re-ed, Exercise</arm_group_label>
    <arm_group_label>NM Re-ed and Exercise</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Exercise</intervention_name>
    <description>Impairment-specific strength training, which may include transversus abdominis (TrA), gluteus maximus/medius/minimus and/or hip abductor/adductor muscle training. Treadmill, riding the recumbent bike at &gt; 2 METs and/or stair climbing. Exercise training will be performed 7-11 treatment sessions over 6 weeks (following treatment 1).</description>
    <arm_group_label>Electric DN, NM Re-ed, Exercise</arm_group_label>
    <arm_group_label>NM Re-ed and Exercise</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Aged 35 - 75 years&#xD;
&#xD;
          2. Female&#xD;
&#xD;
          3. Meet the diagnosis of stress urinary incontinence - urine leakage with increased&#xD;
             abdominal pressure from laughing, sneezing, coughing, or other physical stressors on&#xD;
             abdominal cavity and bladder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Urge urinary incontinence or mixed urinary incontinence&#xD;
&#xD;
          2. Greater than second degree prolapse&#xD;
&#xD;
          3. Previous surgical intervention related to female anatomy&#xD;
&#xD;
          4. Urinary tract infection&#xD;
&#xD;
          5. Unable to participate in movement such as walking, stair climbing, or resistance&#xD;
             training&#xD;
&#xD;
          6. Taking medication that impacts bladder function&#xD;
&#xD;
          7. Serious cardiovascular, cerebral disease, psychiatric disorder, cognitively impaired,&#xD;
             injury of cauda equine, and/or myelopathy&#xD;
&#xD;
          8. Pregnancy&#xD;
&#xD;
          9. Sacral nerve stimulator implanted&#xD;
&#xD;
         10. Cardiac pacemaker, metal allergy, or severe needle phobia&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>35 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>James Dunning, DPT</last_name>
    <role>Principal Investigator</role>
    <affiliation>American Academy of Manipulative Therapy</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Physical Therapy Specialists</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2019</verification_date>
  <study_first_submitted>August 1, 2017</study_first_submitted>
  <study_first_submitted_qc>August 1, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>August 19, 2019</last_update_submitted>
  <last_update_submitted_qc>August 19, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Alabama Physical Therapy &amp; Acupuncture</investigator_affiliation>
    <investigator_full_name>James Dunning, DPT, MSc, FAAOMPT</investigator_full_name>
    <investigator_title>Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Incontinence</mesh_term>
    <mesh_term>Enuresis</mesh_term>
    <mesh_term>Urinary Incontinence, Stress</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03238716
org study id: AAMT0015
nct id: NCT03238716
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this research is to compare two different approaches for treating patients
      with stress urinary incontinence: neuromuscular re-education, impairment-based exercise and
      electric dry needling versus neuromuscular re-education and impairment-based exercise.
      Physical therapists commonly use all of these techniques to treat stress urinary
      incontinence. This study is attempting to find out if one treatment strategy is more
      effective than the other.
Patients with stress urinary incontinence will be randomized to receive 2 treatment sessions
      per week for up to 6 weeks (8-12 sessions total) of either: (1) neuromuscular re-education,
      impairment-based exercise and electric dry needling (2) neuromuscular re-education and
      impairment-based exercise
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Incontinence Impact Questionnaire - Short Form IIQ-7
time frame: baseline, 6 weeks, 3 months
description: 7 questions, each worth 0-3 points. The average score of items responded to is calculated, then multiplied by 33 1/3 to put the scores on a scale of 0 to 100. High scores indicate greater impact of incontinence.
measure: Global Rating of Change Scale
time frame: 6 weeks, 3 months
description: 15 point self-report scale (-7 to 7). High rating indicates a greater impact of change
measure: Urinary pad per day usage
time frame: baseline, 6 weeks, 3 months
description: Number of urinary pads that the patient requires per day secondary to stress urinary incontinence
measure: Urogenital Distress Inventory
time frame: baseline, 6 weeks, 3 months
description: 6 questions, each worth 0-3 points. The raw score is divided by 6 then multiplied by 25 for the total score. High scores indicate more distress due to bladder symptoms.
arm group label: Electric DN, NM Re-ed, Exercise
arm group type: Experimental
arm group label: NM Re-ed and Exercise
arm group type: Active Comparator
intervention type: Other
intervention name: Electric DN
description: Dry needling with electric stimulation to the erector spine and paraspinal muscles in the lumbar / sacral region and tibialis anterior / posterior. Dry needling with electric stimulation of peri-neural tissue associated with lumbar / sacral nerve roots, pudendal nerve and posterior tibial nerve. 8-12 treatment sessions over 6 weeks.
arm group label: Electric DN, NM Re-ed, Exercise
intervention type: Other
intervention name: NM Re-ed
description: sEMG targeting type I slow-twitch fibers and type II fast-twitch fibers. Type I fibers maintain continuous muscle activity over prolonged periods of time; therefore, training of type I fibers will be achieved through endurance and repetition training of the pelvic floor muscles. Type II fibers are recruited during sudden increases in intra-abdominal pressure, and these fibers will be recruited with "The Knack" training. The Knack is a term created to use rhythm or timing to the pelvic floor. Neuromuscular re-education will be performed during the first treatment, but it will be performed "as needed" on subsequent treatments.
arm group label: Electric DN, NM Re-ed, Exercise
arm group label: NM Re-ed and Exercise
intervention type: Other
intervention name: Exercise
description: Impairment-specific strength training, which may include transversus abdominis (TrA), gluteus maximus/medius/minimus and/or hip abductor/adductor muscle training. Treadmill, riding the recumbent bike at > 2 METs and/or stair climbing. Exercise training will be performed 7-11 treatment sessions over 6 weeks (following treatment 1).
arm group label: Electric DN, NM Re-ed, Exercise
arm group label: NM Re-ed and Exercise
criteria: 
gender: Female
minimum age: 35 Years
maximum age: N/A
healthy volunteers: No
last name: James Dunning, DPT
role: Principal Investigator
affiliation: American Academy of Manipulative Therapy
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Alabama Physical Therapy & Acupuncture
investigator full name: James Dunning, DPT, MSc, FAAOMPT
investigator title: Primary Investigator and President of Spinal Manipulation Institute and Dry Needling Institute of the American Academy of Manipulative Therapy
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Urinary Incontinence, Stress
sharing ipd: Undecided