<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/NCT04483817</url>
  </required_header>
  <id_info>
    <org_study_id>EC 06/2019</org_study_id>
    <nct_id>NCT04483817</nct_id>
  </id_info>
  <brief_title>Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Overactive Bladder.</brief_title>
  <official_title>Efficacy of Transcutaneous Versus Percutaneous Posterior Tibial Nerve Stimulation in the Treatment of Overactive Bladder. Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fisiocore LC,SL</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fisiocore LC,SL</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 main aim of this study, is compare the effectiveness of transcutaneous posterior tibial&#xD;
      nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive&#xD;
      bladder.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Overactive bladder syndrome (OAB) is a set of symptoms characterized by urge, with or without&#xD;
      urge incontinence, usually with frequency and nocturia in the absence of urinary infection or&#xD;
      other pathologies. OAB affect considerably the quality of life of the subject who suffer.&#xD;
&#xD;
      The first line of treatment is a conservative management as behavioral interventions,&#xD;
      followed by pharmacological management as antimuscarinic or antimuscarinic drugs.&#xD;
&#xD;
      Percutaneous tibial nerve stimulation (PTNS) is present as another alternative of treatment.&#xD;
      Previous studies have shown the positive effects of PTNS in a reduction on OAB symptoms.&#xD;
&#xD;
      The PTNS was described by Stoller in 1999. It's a electrical stimulation of the tibial nerve,&#xD;
      inserting a 34 gauge needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior&#xD;
      of the tibia, to stimulation of the sacral segments S2 and S3, where the spinal centre of&#xD;
      bladder is located. The parameters used are 20Hz and 200 µs, 12 sessions, two weekly, 30 min&#xD;
      treatment.&#xD;
&#xD;
      The PTNS is a minimal invasive technique, but can be utilized surface electrodes instead of&#xD;
      needle to minimize the discomfort of prick.&#xD;
&#xD;
      The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial&#xD;
      nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive&#xD;
      bladder.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 17, 2019</start_date>
  <completion_date type="Anticipated">September 1, 2023</completion_date>
  <primary_completion_date type="Anticipated">February 1, 2023</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>prospective interventional study</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary frequency</measure>
    <time_frame>two years</time_frame>
    <description>Urinary episodes per day.&#xD;
According to international consensus, it is considered pathological when:&#xD;
There are more than 8 episodes of urination per day</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Nightime voids</measure>
    <time_frame>two years</time_frame>
    <description>Urinary episodes per night.&#xD;
According to international consensus, it is considered pathological when:&#xD;
There is more than 1 episode per night.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Urge episodes</measure>
    <time_frame>two years</time_frame>
    <description>Urinary urge episodes per day. The degree of urgency is measured through the PPIUS scale (outcome no. 4). A grade 3-4 on the PPIUS scale is considered pathological.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Degree of urge to void</measure>
    <time_frame>two years</time_frame>
    <description>Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale).&#xD;
Scale from 0 to 4, where:&#xD;
0 = No urgency;&#xD;
= Slight urgency;&#xD;
= Moderate urgency;&#xD;
= severe urgency;&#xD;
= urge incontinence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Voided volume</measure>
    <time_frame>two years</time_frame>
    <description>Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Overactive Bladder questionnaire Short- Form (OABq-SF)</measure>
    <time_frame>Two years</time_frame>
    <description>This is a questionnaire that evaluates both the symptoms and the quality of life of the patient:&#xD;
Symptom involvement (6 questions): Score of 6-36&#xD;
Quality of life (13 questions): Score of 13-78&#xD;
0-100 metric scale. The higher the score, the more severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>International Consultation on Incontinence Questionnaire (ICIQ-SF)</measure>
    <time_frame>Two years</time_frame>
    <description>This is a self-administered questionnaire that identifies people with urine incontinence (UI) and also assess the impact on quality of life. ICIQ-SF Score: Adding the scores to questions 1+2+3, a score above zero is considered a diagnosis of UI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Benefits, satisfaction and willingness to continue to treatment (BSW)</measure>
    <time_frame>Two years</time_frame>
    <description>The BSD12 questionnaire is a 3 item likert-type questionnaire (benefit, satisfaction and willingness) with an overall score of 0 to 10. Higher scores indicates a better perception of benefit and satisfaction with the treatment, and a greater willingness to continue with it.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">104</enrollment>
  <condition>Overactive Bladder Syndrome</condition>
  <arm_group>
    <arm_group_label>A: Transcutaneous tibial nerve stimulation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The transcutaneous electrostimulation of the posterior tibial nerve (ETNTP) will be applied to group A: place two surface electrodes, one 32 mm in diameter, 5 cm cephalad of the internal malleolus and 1 cm medial posterior of the tibia; and another 50x50 mm electrode in the calcaneous. The flexion of the first toe will indicate the correct placement of the electrodes. Stimulation is performed according to the Stoller method with a stimulator programmed at 20Hz and 200 µs, with a continuous current, 12 sessions, 2 weekly are completed. The intensity of the current will be tolerance by the subject.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>B: Percutaneous tibial nerve stimulation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The percutaneous electrostimulation of the posterior tibial nerve (EPNTP) will be applied to group B: inserting a 0.25x30mm surgical steel needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia , and a surface electrode of 50x50 mm in the calcaneous. The flexion of the first finger will indicate its correct placement. The stimulation parameters will also follow the Stoller method.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Transcutaneous tibial nerve stimulation</intervention_name>
    <description>Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.</description>
    <arm_group_label>A: Transcutaneous tibial nerve stimulation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous tibial nerve stimulation</intervention_name>
    <description>Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.</description>
    <arm_group_label>B: Percutaneous tibial nerve stimulation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects diagnosis of overactive bladder&#xD;
&#xD;
          -  Subjects refractory to treatments antimuscarinic or beta 3-agonist&#xD;
&#xD;
          -  Subjects who do not take restricted medication&#xD;
&#xD;
          -  Subjects who can cognitively complete the voiding diary and questionnaires&#xD;
&#xD;
          -  Subject with symptoms 3 months ago&#xD;
&#xD;
          -  Men must be discarded obstruction by benign prostatic hyperplasia&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with stress incontinence&#xD;
&#xD;
          -  Subjects with urinary tract infection&#xD;
&#xD;
          -  Subjects with neurological disease&#xD;
&#xD;
          -  Subjects with pacemakers fitted&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Subjects who have disorder sensitive&#xD;
&#xD;
          -  A history of pelvic tumors&#xD;
&#xD;
          -  Subject who is not able to understand the physiotherapist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Calzado Sanz, Physiotherap</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fisiocore LC,SL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Calzado Sanz, Physiotherap</last_name>
    <phone>+34 626495479</phone>
    <email>lauracalzado@lcfisioterapia.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>María Torres Lacomba, Physiotherap</last_name>
    <phone>+34 678900061</phone>
    <email>maria.torres@uah.es</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Laura Calzado Sanz</name>
      <address>
        <city>Alcalá de Henares</city>
        <state>Madrid</state>
        <zip>28806</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>http://uroweb.org/guidelines/</url>
    <description>Guidelines of urology´s treatments</description>
  </link>
  <link>
    <url>http://www.teknon.es/idcsalud-client/cm/images?idMmedia=444713</url>
    <description>Guidelines of AEU (Asociación Española de Urología)</description>
  </link>
  <reference>
    <citation>Wibisono E, Rahardjo HE. Effectiveness of Short Term Percutaneous Tibial Nerve Stimulation for Non-neurogenic Overactive Bladder Syndrome in Adults: A Meta-analysis. Acta Med Indones. 2015 Jul;47(3):188-200.</citation>
    <PMID>26586384</PMID>
  </reference>
  <results_reference>
    <citation>Yoong W, Ridout AE, Damodaram M, Dadswell R. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int. 2010 Dec;106(11):1673-6. doi: 10.1111/j.1464-410X.2010.09461.x.</citation>
    <PMID>20590544</PMID>
  </results_reference>
  <results_reference>
    <citation>Civic D, Black E. Re: Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial: K. M. Peters, D. J. Carrico, R. A. Perez-Marrero, A. U. Khan, L. S. Wooldridge, G. L. Davis and S. A. MacDiarmid J Urol 2010; 183: 1438-1443. J Urol. 2011 Jan;185(1):362; author reply 362-4. doi: 10.1016/j.juro.2010.09.030. Epub 2010 Nov 18. No abstract available.</citation>
    <PMID>21092997</PMID>
  </results_reference>
  <results_reference>
    <citation>Sajadi KP, Goldman HB. Percutaneous tibial nerve stimulation and overactive bladder. Curr Urol Rep. 2010 Sep;11(5):293-5. doi: 10.1007/s11934-010-0126-4. No abstract available.</citation>
    <PMID>20567947</PMID>
  </results_reference>
  <results_reference>
    <citation>Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The effectiveness of transcutaneous tibial nerve stimulation (TTNS) for adults with overactive bladder syndrome: A systematic review. Neurourol Urodyn. 2018 Feb;37(2):528-541. doi: 10.1002/nau.23351. Epub 2017 Jul 21.</citation>
    <PMID>28731583</PMID>
  </results_reference>
  <results_reference>
    <citation>Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012 Nov;31(8):1206-16. doi: 10.1002/nau.22251. Epub 2012 May 11.</citation>
    <PMID>22581511</PMID>
  </results_reference>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>March 27, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 23, 2020</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>urgency</keyword>
  <keyword>incontinence</keyword>
  <keyword>nocturia</keyword>
  <keyword>frequency</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Urinary Bladder, Overactive</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/NCT04483817
org study id: EC 06/2019
nct id: NCT04483817
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial
      nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive
      bladder.
Overactive bladder syndrome (OAB) is a set of symptoms characterized by urge, with or without
      urge incontinence, usually with frequency and nocturia in the absence of urinary infection or
      other pathologies. OAB affect considerably the quality of life of the subject who suffer.

      The first line of treatment is a conservative management as behavioral interventions,
      followed by pharmacological management as antimuscarinic or antimuscarinic drugs.

      Percutaneous tibial nerve stimulation (PTNS) is present as another alternative of treatment.
      Previous studies have shown the positive effects of PTNS in a reduction on OAB symptoms.

      The PTNS was described by Stoller in 1999. It's a electrical stimulation of the tibial nerve,
      inserting a 34 gauge needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior
      of the tibia, to stimulation of the sacral segments S2 and S3, where the spinal centre of
      bladder is located. The parameters used are 20Hz and 200 µs, 12 sessions, two weekly, 30 min
      treatment.

      The PTNS is a minimal invasive technique, but can be utilized surface electrodes instead of
      needle to minimize the discomfort of prick.

      The main aim of this study, is compare the effectiveness of transcutaneous posterior tibial
      nerve stimulation versus percutaneous posterior nerve stimulation in patients with overactive
      bladder.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: prospective interventional study
primary purpose: Treatment
masking: Single (Investigator)
measure: Urinary frequency
time frame: two years
description: Urinary episodes per day.
According to international consensus, it is considered pathological when:
There are more than 8 episodes of urination per day
measure: Nightime voids
time frame: two years
description: Urinary episodes per night.
According to international consensus, it is considered pathological when:
There is more than 1 episode per night.
measure: Urge episodes
time frame: two years
description: Urinary urge episodes per day. The degree of urgency is measured through the PPIUS scale (outcome no. 4). A grade 3-4 on the PPIUS scale is considered pathological.
measure: Degree of urge to void
time frame: two years
description: Measured through the PPIUS (Patient Perception of Intensity of Urgency Scale).
Scale from 0 to 4, where:
0 = No urgency;
= Slight urgency;
= Moderate urgency;
= severe urgency;
= urge incontinence.
measure: Voided volume
time frame: two years
description: Urine 24 hours volume. Voiding volume over 3000cc in 24 hours, is considered pathological.
measure: Overactive Bladder questionnaire Short- Form (OABq-SF)
time frame: Two years
description: This is a questionnaire that evaluates both the symptoms and the quality of life of the patient:
Symptom involvement (6 questions): Score of 6-36
Quality of life (13 questions): Score of 13-78
0-100 metric scale. The higher the score, the more severity.
measure: International Consultation on Incontinence Questionnaire (ICIQ-SF)
time frame: Two years
description: This is a self-administered questionnaire that identifies people with urine incontinence (UI) and also assess the impact on quality of life. ICIQ-SF Score: Adding the scores to questions 1+2+3, a score above zero is considered a diagnosis of UI.
measure: Benefits, satisfaction and willingness to continue to treatment (BSW)
time frame: Two years
description: The BSD12 questionnaire is a 3 item likert-type questionnaire (benefit, satisfaction and willingness) with an overall score of 0 to 10. Higher scores indicates a better perception of benefit and satisfaction with the treatment, and a greater willingness to continue with it.
arm group label: A: Transcutaneous tibial nerve stimulation
arm group type: Experimental
description: The transcutaneous electrostimulation of the posterior tibial nerve (ETNTP) will be applied to group A: place two surface electrodes, one 32 mm in diameter, 5 cm cephalad of the internal malleolus and 1 cm medial posterior of the tibia; and another 50x50 mm electrode in the calcaneous. The flexion of the first toe will indicate the correct placement of the electrodes. Stimulation is performed according to the Stoller method with a stimulator programmed at 20Hz and 200 µs, with a continuous current, 12 sessions, 2 weekly are completed. The intensity of the current will be tolerance by the subject.
arm group label: B: Percutaneous tibial nerve stimulation
arm group type: Active Comparator
description: The percutaneous electrostimulation of the posterior tibial nerve (EPNTP) will be applied to group B: inserting a 0.25x30mm surgical steel needle at a 60º angle, 5 cm cephalad to the malleolus and 1 cm posterior of the tibia , and a surface electrode of 50x50 mm in the calcaneous. The flexion of the first finger will indicate its correct placement. The stimulation parameters will also follow the Stoller method.
intervention type: Device
intervention name: Transcutaneous tibial nerve stimulation
description: Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
arm group label: A: Transcutaneous tibial nerve stimulation
intervention type: Device
intervention name: Percutaneous tibial nerve stimulation
description: Apply tibial nerve stimulation with surface electrodes in the treatment of overactive bladder.
arm group label: B: Percutaneous tibial nerve stimulation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Laura Calzado Sanz, Physiotherap
role: Principal Investigator
affiliation: Fisiocore LC,SL
last name: Laura Calzado Sanz, Physiotherap
phone: +34 626495479
email: lauracalzado@lcfisioterapia.com
last name: María Torres Lacomba, Physiotherap
phone: +34 678900061
email: maria.torres@uah.es
facility: 
status: Recruiting
country: Spain
url: http://uroweb.org/guidelines/
description: Guidelines of urology´s treatments
url: http://www.teknon.es/idcsalud-client/cm/images?idMmedia=444713
description: Guidelines of AEU (Asociación Española de Urología)
citation: Wibisono E, Rahardjo HE. Effectiveness of Short Term Percutaneous Tibial Nerve Stimulation for Non-neurogenic Overactive Bladder Syndrome in Adults: A Meta-analysis. Acta Med Indones. 2015 Jul;47(3):188-200.
PMID: 26586384
citation: Yoong W, Ridout AE, Damodaram M, Dadswell R. Neuromodulative treatment with percutaneous tibial nerve stimulation for intractable detrusor instability: outcomes following a shortened 6-week protocol. BJU Int. 2010 Dec;106(11):1673-6. doi: 10.1111/j.1464-410X.2010.09461.x.
PMID: 20590544
citation: Civic D, Black E. Re: Randomized trial of percutaneous tibial nerve stimulation versus sham efficacy in the treatment of overactive bladder syndrome: results from the SUmiT trial: K. M. Peters, D. J. Carrico, R. A. Perez-Marrero, A. U. Khan, L. S. Wooldridge, G. L. Davis and S. A. MacDiarmid J Urol 2010; 183: 1438-1443. J Urol. 2011 Jan;185(1):362; author reply 362-4. doi: 10.1016/j.juro.2010.09.030. Epub 2010 Nov 18. No abstract available.
PMID: 21092997
citation: Sajadi KP, Goldman HB. Percutaneous tibial nerve stimulation and overactive bladder. Curr Urol Rep. 2010 Sep;11(5):293-5. doi: 10.1007/s11934-010-0126-4. No abstract available.
PMID: 20567947
citation: Booth J, Connelly L, Dickson S, Duncan F, Lawrence M. The effectiveness of transcutaneous tibial nerve stimulation (TTNS) for adults with overactive bladder syndrome: A systematic review. Neurourol Urodyn. 2018 Feb;37(2):528-541. doi: 10.1002/nau.23351. Epub 2017 Jul 21.
PMID: 28731583
citation: Burton C, Sajja A, Latthe PM. Effectiveness of percutaneous posterior tibial nerve stimulation for overactive bladder: a systematic review and meta-analysis. Neurourol Urodyn. 2012 Nov;31(8):1206-16. doi: 10.1002/nau.22251. Epub 2012 May 11.
PMID: 22581511
responsible party type: Sponsor
mesh term: Urinary Bladder, Overactive
sharing ipd: No