<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/NCT04450511</url>
  </required_header>
  <id_info>
    <org_study_id>60116787-020/37878</org_study_id>
    <nct_id>NCT04450511</nct_id>
  </id_info>
  <brief_title>Pelvic Floor Magnetic Stimulation in Women With Idiopathic Overactive Bladder</brief_title>
  <official_title>Combined Effect of Pelvic Floor Magnetic Stimulation and Bladder Training in Women With Idiopathic Overactive Bladder: A Prospective Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Pamukkale University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Pamukkale University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In clinical practice, Bladder Training (BT) and Magnetic stimulation (MS) are frequently used&#xD;
      together in the treatment of women with idiopathic overactive bladder (OAB). Up to our&#xD;
      knowledge, there is no study evaluating the combined effect of magnetic stimulation and&#xD;
      bladder training in women with idiopathic OAB in the literature. Moreover, there is no&#xD;
      recommendation on conservative treatment combinations in the guidelines due to insufficient&#xD;
      data. At this stage, studies are needed to determine whether it will be effective to use MS&#xD;
      in combination with other conservative treatment options. In addition, in the light of our&#xD;
      clinical experience, we think that this issue is still open for research. In our study,&#xD;
      adding MS to BT in women with idiopathic OAB is thought to contribute additionally to the&#xD;
      efficacy of treatment with BT.&#xD;
&#xD;
      Our study is the first prospective randomized controlled trial that compares the efficacy of&#xD;
      BT and BT plus MS in women with idiopathic OAB. In this study, we aimed to evaluate the&#xD;
      efficacy of MS added to BT on incontinence-related QoL and clinical parameters in women with&#xD;
      idiopathic OAB.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a prospectively randomized, controlled trial. The trial is held at&#xD;
      Urogynecological Rehabilitation Unit of University Hospital, Physical Medicine and&#xD;
      Rehabilitation Department between September 2020 and November 2021. The local ethics&#xD;
      committee approve the study (approval no: 60116787-020/37878). Patients are informed about&#xD;
      the purpose and contents of the study and all women give written consent to participate.&#xD;
&#xD;
      By using a random number generator, all patients which included the study were randomized&#xD;
      into two groups as follows: The Group 1 received BT program alone, the Group 2 received BT&#xD;
      plus MS.&#xD;
&#xD;
      Group 1: Bladder Training (BT) - Control group All women were informed about BT for 30&#xD;
      minutes. Then it was given as a written brochure to be implemented as a home program.&#xD;
&#xD;
      BT, consisting of four stages, did not contain any pelvic floor muscle (PFM) training&#xD;
      programs in two groups.&#xD;
&#xD;
      Group 2: BT plus MS Patients are told to sit on the chair with a magnetic coil below the&#xD;
      chair. When a volume conductor is inserted by this magnetic ﬁeld, an eddy current ﬂow is&#xD;
      generated. This eddy current stimulates nerve or muscle of the pelvic ﬂoor. To apply MS, the&#xD;
      device was set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and&#xD;
      a stimulation repetition cycle of 10 Hz in accordance with the literature (10,13-15). When&#xD;
      setting the device at each treatment session, patients were interviewed so that they received&#xD;
      stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) (10).&#xD;
      MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MS&#xD;
      sessions were performed by other physician.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2020</start_date>
  <completion_date type="Actual">November 29, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incontinence episodes</measure>
    <time_frame>6 weeks</time_frame>
    <description>Patients with a 50% or greater reduction in incontinence episodes were consider positive responders</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severity of incontinence</measure>
    <time_frame>6 weeks</time_frame>
    <description>The 24-hour pad test was carried out to evaluate urinary loss.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Nocturia</measure>
    <time_frame>6 weeks</time_frame>
    <description>It was used &quot;nocturia&quot; from data collected with a 3-day bladder diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency</measure>
    <time_frame>6 weeks</time_frame>
    <description>It was used &quot;frequency&quot; from data collected with a 3-day bladder diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of pads</measure>
    <time_frame>6 weeks</time_frame>
    <description>It was used &quot;number of pads&quot; from data collected with a 3-day bladder diary.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptom severity</measure>
    <time_frame>6 weeks</time_frame>
    <description>Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>QoL</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Incontinence Impact Questionnaire (IIQ-7) scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Functions</measure>
    <time_frame>6 weeks</time_frame>
    <description>The Female Sexual Function Index (FSFI) is a valid, reliable, and anonymously designed ques¬tionnaire with six areas (desire, subjective arousal, lubrica¬tion, orgasm, satisfaction, pain), and includes 19 questions that measure female sexual function.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cure and improvement rate</measure>
    <time_frame>6 weeks</time_frame>
    <description>In 24-hour pad test, 1.3 gr under of it was considered as a cure. The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">76</enrollment>
  <condition>Urge Incontinence Episodes After the Magnetic Stimulation Added to Bladder Training in Women With Idiopathic Overactive Bladder</condition>
  <arm_group>
    <arm_group_label>Group 1: Bladder Training (BT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>BT, consisting of four stages, did not contain any PFM training programs in all groups. In these stages, including urgency suppression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women were encouraged to pause/stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2: Bladder Training+Magnetic Stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted by this magnetic ﬁeld, an eddy current ﬂow is generated. This eddy current stimulates nerve or muscle of the pelvic ﬂoor. To apply MS, the device was set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Magnetic stimulation -Armchair type (MS)</intervention_name>
    <description>MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.</description>
    <arm_group_label>Group 2: Bladder Training+Magnetic Stimulation</arm_group_label>
    <other_name>Extracorporeal magnetic stimulation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bladder Training (BT)</intervention_name>
    <description>Bladder Training (BT)</description>
    <arm_group_label>Group 1: Bladder Training (BT)</arm_group_label>
    <arm_group_label>Group 2: Bladder Training+Magnetic Stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Women over the age of 18 with clinical diagnosis of idiopathic OAB&#xD;
&#xD;
          2. Urodynamically confirmed detrusor overactivity (the presence of detrusor contractions&#xD;
             in the ﬁlling phase of saline cystometry)&#xD;
&#xD;
          3. Not tolerated or unresponsive to antimuscarinics and discontinued at least 4 weeks&#xD;
&#xD;
          4. Able to give written, informed consent&#xD;
&#xD;
          5. Able to understand the procedures, advantages and possible side effects&#xD;
&#xD;
          6. Willing and able to complete the voiding diary and QoL questionnaire&#xD;
&#xD;
          7. The strength of PFM 3/5 and more&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of BT, MS therapy&#xD;
&#xD;
          2. Pregnancy or intention to become pregnant during the study&#xD;
&#xD;
          3. Current vulvovaginitis or urinary tract infections or malignancy&#xD;
&#xD;
          4. More than stage 2 according to the pelvic organ prolapse quantification&#xD;
&#xD;
          5. Cardiac pacemaker, implanted defibrillator, coronary artery stent&#xD;
&#xD;
          6. Ongoing treatment for arrhythmia&#xD;
&#xD;
          7. Lower abdominal pain or dysmenorrhea yet to be diagnosed&#xD;
&#xD;
          8. Electronic device or metallic implant applied to areas between the lumbar region and&#xD;
             lower extremities&#xD;
&#xD;
          9. Previous urogynecological surgery within 3 months&#xD;
&#xD;
         10. Ongoing surgical treatment or treatment with implantable devices for urinary&#xD;
             incontinence or use of intrauterine copper devices&#xD;
&#xD;
         11. Neurogenic bladder, signs of neurologic abnormalities at objective examination;&#xD;
             history of the peripheral or central neurologic pathology&#xD;
&#xD;
         12. Ultrasonographic evidence of post voiding residual volume more than 100 ml&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Women over the age of 18 with clinical diagnosis of idiopathic OAB and urodynamically conﬁrmed detrusor overactivity (the presence of detrusor contractions in the ﬁlling phase of saline cystometry)</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Pamukkale University</name>
      <address>
        <city>Denizli</city>
        <state>Kınıklı</state>
        <zip>20100</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>June 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 29, 2020</study_first_posted>
  <last_update_submitted>October 31, 2022</last_update_submitted>
  <last_update_submitted_qc>October 31, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 1, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Pamukkale University</investigator_affiliation>
    <investigator_full_name>Necmettin Yildiz</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>idiopathic overactive bladder</keyword>
  <keyword>bladder training</keyword>
  <keyword>magnetic stimulation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04450511
org study id: 60116787-020/37878
nct id: NCT04450511
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
In clinical practice, Bladder Training (BT) and Magnetic stimulation (MS) are frequently used
      together in the treatment of women with idiopathic overactive bladder (OAB). Up to our
      knowledge, there is no study evaluating the combined effect of magnetic stimulation and
      bladder training in women with idiopathic OAB in the literature. Moreover, there is no
      recommendation on conservative treatment combinations in the guidelines due to insufficient
      data. At this stage, studies are needed to determine whether it will be effective to use MS
      in combination with other conservative treatment options. In addition, in the light of our
      clinical experience, we think that this issue is still open for research. In our study,
      adding MS to BT in women with idiopathic OAB is thought to contribute additionally to the
      efficacy of treatment with BT.

      Our study is the first prospective randomized controlled trial that compares the efficacy of
      BT and BT plus MS in women with idiopathic OAB. In this study, we aimed to evaluate the
      efficacy of MS added to BT on incontinence-related QoL and clinical parameters in women with
      idiopathic OAB.
This study is a prospectively randomized, controlled trial. The trial is held at
      Urogynecological Rehabilitation Unit of University Hospital, Physical Medicine and
      Rehabilitation Department between September 2020 and November 2021. The local ethics
      committee approve the study (approval no: 60116787-020/37878). Patients are informed about
      the purpose and contents of the study and all women give written consent to participate.

      By using a random number generator, all patients which included the study were randomized
      into two groups as follows: The Group 1 received BT program alone, the Group 2 received BT
      plus MS.

      Group 1: Bladder Training (BT) - Control group All women were informed about BT for 30
      minutes. Then it was given as a written brochure to be implemented as a home program.

      BT, consisting of four stages, did not contain any pelvic floor muscle (PFM) training
      programs in two groups.

      Group 2: BT plus MS Patients are told to sit on the chair with a magnetic coil below the
      chair. When a volume conductor is inserted by this magnetic ﬁeld, an eddy current ﬂow is
      generated. This eddy current stimulates nerve or muscle of the pelvic ﬂoor. To apply MS, the
      device was set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and
      a stimulation repetition cycle of 10 Hz in accordance with the literature (10,13-15). When
      setting the device at each treatment session, patients were interviewed so that they received
      stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) (10).
      MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks. MS
      sessions were performed by other physician.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Incontinence episodes
time frame: 6 weeks
description: Patients with a 50% or greater reduction in incontinence episodes were consider positive responders
measure: Severity of incontinence
time frame: 6 weeks
description: The 24-hour pad test was carried out to evaluate urinary loss.
measure: Nocturia
time frame: 6 weeks
description: It was used "nocturia" from data collected with a 3-day bladder diary.
measure: Frequency
time frame: 6 weeks
description: It was used "frequency" from data collected with a 3-day bladder diary.
measure: Number of pads
time frame: 6 weeks
description: It was used "number of pads" from data collected with a 3-day bladder diary.
measure: Symptom severity
time frame: 6 weeks
description: Overactive Bladder Questionnaire (OAB-V8) was used to evaluate symptom severity in patients with in the study.
measure: QoL
time frame: 6 weeks
description: The Incontinence Impact Questionnaire (IIQ-7) scale which has great validity in studies was used to assess the patient's QoL associated with incontinence problem
measure: Sexual Functions
time frame: 6 weeks
description: The Female Sexual Function Index (FSFI) is a valid, reliable, and anonymously designed ques¬tionnaire with six areas (desire, subjective arousal, lubrica¬tion, orgasm, satisfaction, pain), and includes 19 questions that measure female sexual function.
measure: Cure and improvement rate
time frame: 6 weeks
description: In 24-hour pad test, 1.3 gr under of it was considered as a cure. The improvement was assessed in terms of 50% and more reduction in wet weight compared to baseline measurements in the 24-hour pad test
arm group label: Group 1: Bladder Training (BT)
arm group type: Active Comparator
description: BT, consisting of four stages, did not contain any PFM training programs in all groups. In these stages, including urgency suppression strategies, it was aimed to delay urination, to inhibit detrusor contraction and to prevent urgency; by squeezing the PFM several times in a row (women were encouraged to pause/stop their work, sit down if possible, relax the entire body and squeeze PFM repeatedly), breathing deeply, giving their attention to another job for a while and self-motivating (I can do it, I can check the urination, etc.).
arm group label: Group 2: Bladder Training+Magnetic Stimulation
arm group type: Experimental
description: Patients are told to sit on the chair with a magnetic coil below the chair. When a volume conductor is inserted by this magnetic ﬁeld, an eddy current ﬂow is generated. This eddy current stimulates nerve or muscle of the pelvic ﬂoor. To apply MS, the device was set to generate its maximum stimuli, with a stimulation pulse width of 200 μs and a stimulation repetition cycle of 10 Hz in accordance with the literature. When setting the device at each treatment session, patients were interviewed so that they received stimuli at the maximum stimulation intensity (maximum tolerable stimulation intensity) .
intervention type: Device
intervention name: Magnetic stimulation -Armchair type (MS)
description: MS was applied two days a week, 20 minutes a day, a total of 12 sessions for 6 weeks.
arm group label: Group 2: Bladder Training+Magnetic Stimulation
other name: Extracorporeal magnetic stimulation
intervention type: Other
intervention name: Bladder Training (BT)
description: Bladder Training (BT)
arm group label: Group 1: Bladder Training (BT)
arm group label: Group 2: Bladder Training+Magnetic Stimulation
criteria: 
gender: Female
gender based: Yes
gender description: Women over the age of 18 with clinical diagnosis of idiopathic OAB and urodynamically conﬁrmed detrusor overactivity (the presence of detrusor contractions in the ﬁlling phase of saline cystometry)
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Pamukkale University
investigator full name: Necmettin Yildiz
investigator title: Professor
mesh term: Urinary Bladder, Overactive
mesh term: Urinary Incontinence, Urge
sharing ipd: No