<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/NCT04446598</url>
  </required_header>
  <id_info>
    <org_study_id>CPPS/CP-01</org_study_id>
    <nct_id>NCT04446598</nct_id>
  </id_info>
  <brief_title>Management of Prostatodynia in Younger Patients With Non-ablative Erbium:YAG Intraurethral Laser</brief_title>
  <official_title>Non Ablative Erbium:YAG Laser Transurethral Treatment for Chronic Prostatitis/Chronic Pelvic Pain Syndrome in Younger Patients: a Prospective Comparative Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Adrian Gaspar</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Espacio Gaspar Clinic</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>
      This prospective study aimed to compare the clinical outcomes between the use of the erbium:&#xD;
      YAG (Er:YAG) laser, intraurethrally administered in long non-ablative SMOOTH™ train of pulses&#xD;
      applied at the level of the male prostatic urethra, to the use of the pharmacological&#xD;
      treatment of oral tadalafil for the treatment of chronic prostatitis/chronic pelvic pain&#xD;
      syndrome (CP/CPPS). The results show that both treatments are effective in alleviating&#xD;
      symptoms of CP/CPPS. The non-ablative Er:YAG SMOOTHTM laser seems to be a promising treatment&#xD;
      for this widely spread condition. More studies are needed to confirm its safety and efficacy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prostatitis is the most common diagnosis (&gt;50%) in men visiting outpatient urological clinics&#xD;
      .&#xD;
&#xD;
      The NIH classification classifies prostatitis into 4 types: category I - acute bacterial&#xD;
      prostatitis, which is very rare, affecting only up to 5% of patients; category II- chronic&#xD;
      bacterial prostatitis, also affecting up to 5% of patients; category III- chronic&#xD;
      nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS), which is the most common, as&#xD;
      it affects 90%-95% of cases; and Category IV- asymptomatic inﬂammatory prostatitis, which has&#xD;
      unknown prevalence and also unknown clinical significance.&#xD;
&#xD;
      Although category III or CP/CPPS is the most prevalent form of prostatitis, its causes are&#xD;
      largely unknown and treatments often fail to alleviate symptoms in the long term. In&#xD;
      contrast, patients suffering from type I and II prostatitis are successfully treated with&#xD;
      antibiotics, as a uropathogen or an infectious agent is usually identified as the cause .&#xD;
&#xD;
      CP/CPPS is characterized by pain in the perineum and tenderness in the prostate and various&#xD;
      urological symptoms (urgency, frequency, low urethral pressure) and sometimes also&#xD;
      ejaculatory symptoms, such as painful ejaculation.&#xD;
&#xD;
      Currently used treatments for CP/CPPS are mainly pharmacological, including alpha blockers,&#xD;
      5-alpha reductase inhibitors, anti-inflammatories, antibiotics, phytotherapy, allopurinol,&#xD;
      botulinum toxin and traditional Chinese medicine . Non-pharmacological therapies include&#xD;
      acupuncture, prostatic massage, extracorporeal shockwave therapy, pulsed magnetic field&#xD;
      therapy, transrectal and transurethral thermotherapy and others . Some of the abovementioned&#xD;
      therapies alleviate symptoms by improving vascularisation and blood flow of the prostate and&#xD;
      peri-prostatic area. This is also the mechanism of action of the erbium:YAG (Er:YAG) laser&#xD;
      with non-ablative SMOOTH™ mode - it works by thermal pulsing of the treated surface, with&#xD;
      microsecond-range long pulses combined into long (several hundred millisecond range)&#xD;
      sequences. Each laser micropulse sharply increases tissue temperature and acts as a&#xD;
      stimulative trigger. Long pulse trains cause slower diffusion of heat to deeper layers of the&#xD;
      skin or mucosa, causing initially vasodilation and then collagen remodelling and stimulation&#xD;
      of fibroblasts with collagen remodelling. It has shown to improve vascularisation and&#xD;
      alleviate symptoms of genitourinary syndrome of menopause (GSM) in women, including&#xD;
      irritation, dryness and pain. It has also been used intraurethrally in women to alleviate&#xD;
      urinary symptoms of GSM. Intraurethral thermal therapy has been previously shown promising in&#xD;
      the treatment of CP/CPPS in men. In this study the investigators aimed to assess the safety&#xD;
      and effectiveness of transurethral non-ablative Er:YAG laser therapy applied at the level of&#xD;
      the male prostatic urethra and to compare it with pharmacological treatment of 5 mg oral&#xD;
      tadalafil for the treatment of CP/CPPS.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Actual">December 31, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Maximum urethral flow value (Q-max)</measure>
    <time_frame>Change from Baseline Q-max at 3 and 6 months following the intervention</time_frame>
    <description>measurement of maximum urethral flow using uroflowmetry</description>
  </primary_outcome>
  <primary_outcome>
    <measure>IPSS questionnaire</measure>
    <time_frame>Change from Baseline IPSS score at 1, 3, 6 and 12 months following the intervention</time_frame>
    <description>Assessment of urinary symptoms using the International Prostate Symptom Score (IPSS)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain assesment: VAS (visual analog scale) scale</measure>
    <time_frame>Change from Baseline pain VAS score at 1, 3, 6 and 12 months following the intervention</time_frame>
    <description>subjective assesment of pain using 0 (minimum) to 10 (maximum) VAS scale. 0 means no pain, 10 means worst possible pain;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>dysuria assesment: VAS (visual analog scale) scale</measure>
    <time_frame>Change from Baseline dysuria VAS score at 1,3, 6 and 12 months following the intervention</time_frame>
    <description>subjective assesment of dysuria using 0 (minimum) to 10 (maximum) VAS scale. 0 means no dysuria, 10 means worst possible dysuria;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: 7-point Likert Scale</measure>
    <time_frame>6 months following the intervention</time_frame>
    <description>subjective assessment of patients' satisfaction with the treatment using 0 to 6 Likert Scale; Question - How satisfied are you with the treatment? Likert scale: 0 - extremely satisfied; 1- very satisfied; 2 - mostly satisfied; 3 - neither satisfied nor unsatisfied; 4 - mostly unsatisfied; 5 - very unsatisfied; 6- extremely unsatisfied</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: 7-point Likert Scale</measure>
    <time_frame>12 months following the intervention</time_frame>
    <description>subjective assessment of patients' satisfaction with the treatment using 0 to 6 Likert Scale; Question - How satisfied are you with the treatment? Likert scale: 0 - extremely satisfied; 1- very satisfied; 2 - mostly satisfied; 3 - neither satisfied nor unsatisfied; 4 - mostly unsatisfied; 5 - very unsatisfied; 6- extremely unsatisfied</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">36</enrollment>
  <condition>Chronic Prostatitis With Chronic Pelvic Pain Syndrome</condition>
  <condition>Prostatodynia</condition>
  <arm_group>
    <arm_group_label>Laser group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the laser group, the patients received two sessions of Er:YAG intraurethral laser in non-ablative SMOOTH™ mode, with 1 month interval between sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tadalafil group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The tadalafil group was treated with daily oral administration of tadalafil, at a dose of 5 mg/day, which lasted consecutively for two months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>non-ablative SMOOTH mode Erbium YAG laser</intervention_name>
    <description>Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode</description>
    <arm_group_label>Laser group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tadalafil 5mg</intervention_name>
    <description>oral tadalafil 5 mg was administered daily over a period of two months</description>
    <arm_group_label>Tadalafil group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  clinical diagnosis of chronic prostatitis/chronic pelvic pain syndrome with&#xD;
             characteristic symptoms of perineal pain and urinary symptoms of dysuria and urinary&#xD;
             frequency;&#xD;
&#xD;
          -  negative urine culture after prostatic massage; prostatic volume less than 50 cc in&#xD;
             prostatic ultrasound;&#xD;
&#xD;
          -  obstructive uroflowmetric pattern with a Q-max value between 10 and 15 ml/sec&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age over 50 years&#xD;
&#xD;
          -  current or recent (last 6 months) pharmacological or other therapies of CP/CPPS&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Uroclinica</name>
      <address>
        <city>Mendoza</city>
        <country>Argentina</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Argentina</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 3, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 25, 2020</study_first_posted>
  <last_update_submitted>June 23, 2020</last_update_submitted>
  <last_update_submitted_qc>June 23, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 25, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Espacio Gaspar Clinic</investigator_affiliation>
    <investigator_full_name>Adrian Gaspar</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatitis</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Pelvic Pain</mesh_term>
    <mesh_term>Chronic Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tadalafil</mesh_term>
  </intervention_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/NCT04446598
org study id: CPPS/CP-01
nct id: NCT04446598
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This prospective study aimed to compare the clinical outcomes between the use of the erbium:
      YAG (Er:YAG) laser, intraurethrally administered in long non-ablative SMOOTH™ train of pulses
      applied at the level of the male prostatic urethra, to the use of the pharmacological
      treatment of oral tadalafil for the treatment of chronic prostatitis/chronic pelvic pain
      syndrome (CP/CPPS). The results show that both treatments are effective in alleviating
      symptoms of CP/CPPS. The non-ablative Er:YAG SMOOTHTM laser seems to be a promising treatment
      for this widely spread condition. More studies are needed to confirm its safety and efficacy.
Prostatitis is the most common diagnosis (>50%) in men visiting outpatient urological clinics
      .

      The NIH classification classifies prostatitis into 4 types: category I - acute bacterial
      prostatitis, which is very rare, affecting only up to 5% of patients; category II- chronic
      bacterial prostatitis, also affecting up to 5% of patients; category III- chronic
      nonbacterial prostatitis/chronic pelvic pain syndrome (CP/CPPS), which is the most common, as
      it affects 90%-95% of cases; and Category IV- asymptomatic inﬂammatory prostatitis, which has
      unknown prevalence and also unknown clinical significance.

      Although category III or CP/CPPS is the most prevalent form of prostatitis, its causes are
      largely unknown and treatments often fail to alleviate symptoms in the long term. In
      contrast, patients suffering from type I and II prostatitis are successfully treated with
      antibiotics, as a uropathogen or an infectious agent is usually identified as the cause .

      CP/CPPS is characterized by pain in the perineum and tenderness in the prostate and various
      urological symptoms (urgency, frequency, low urethral pressure) and sometimes also
      ejaculatory symptoms, such as painful ejaculation.

      Currently used treatments for CP/CPPS are mainly pharmacological, including alpha blockers,
      5-alpha reductase inhibitors, anti-inflammatories, antibiotics, phytotherapy, allopurinol,
      botulinum toxin and traditional Chinese medicine . Non-pharmacological therapies include
      acupuncture, prostatic massage, extracorporeal shockwave therapy, pulsed magnetic field
      therapy, transrectal and transurethral thermotherapy and others . Some of the abovementioned
      therapies alleviate symptoms by improving vascularisation and blood flow of the prostate and
      peri-prostatic area. This is also the mechanism of action of the erbium:YAG (Er:YAG) laser
      with non-ablative SMOOTH™ mode - it works by thermal pulsing of the treated surface, with
      microsecond-range long pulses combined into long (several hundred millisecond range)
      sequences. Each laser micropulse sharply increases tissue temperature and acts as a
      stimulative trigger. Long pulse trains cause slower diffusion of heat to deeper layers of the
      skin or mucosa, causing initially vasodilation and then collagen remodelling and stimulation
      of fibroblasts with collagen remodelling. It has shown to improve vascularisation and
      alleviate symptoms of genitourinary syndrome of menopause (GSM) in women, including
      irritation, dryness and pain. It has also been used intraurethrally in women to alleviate
      urinary symptoms of GSM. Intraurethral thermal therapy has been previously shown promising in
      the treatment of CP/CPPS in men. In this study the investigators aimed to assess the safety
      and effectiveness of transurethral non-ablative Er:YAG laser therapy applied at the level of
      the male prostatic urethra and to compare it with pharmacological treatment of 5 mg oral
      tadalafil for the treatment of CP/CPPS.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Maximum urethral flow value (Q-max)
time frame: Change from Baseline Q-max at 3 and 6 months following the intervention
description: measurement of maximum urethral flow using uroflowmetry
measure: IPSS questionnaire
time frame: Change from Baseline IPSS score at 1, 3, 6 and 12 months following the intervention
description: Assessment of urinary symptoms using the International Prostate Symptom Score (IPSS)
measure: pain assesment: VAS (visual analog scale) scale
time frame: Change from Baseline pain VAS score at 1, 3, 6 and 12 months following the intervention
description: subjective assesment of pain using 0 (minimum) to 10 (maximum) VAS scale. 0 means no pain, 10 means worst possible pain;
measure: dysuria assesment: VAS (visual analog scale) scale
time frame: Change from Baseline dysuria VAS score at 1,3, 6 and 12 months following the intervention
description: subjective assesment of dysuria using 0 (minimum) to 10 (maximum) VAS scale. 0 means no dysuria, 10 means worst possible dysuria;
measure: Patient satisfaction: 7-point Likert Scale
time frame: 6 months following the intervention
description: subjective assessment of patients' satisfaction with the treatment using 0 to 6 Likert Scale; Question - How satisfied are you with the treatment? Likert scale: 0 - extremely satisfied; 1- very satisfied; 2 - mostly satisfied; 3 - neither satisfied nor unsatisfied; 4 - mostly unsatisfied; 5 - very unsatisfied; 6- extremely unsatisfied
measure: Patient satisfaction: 7-point Likert Scale
time frame: 12 months following the intervention
description: subjective assessment of patients' satisfaction with the treatment using 0 to 6 Likert Scale; Question - How satisfied are you with the treatment? Likert scale: 0 - extremely satisfied; 1- very satisfied; 2 - mostly satisfied; 3 - neither satisfied nor unsatisfied; 4 - mostly unsatisfied; 5 - very unsatisfied; 6- extremely unsatisfied
arm group label: Laser group
arm group type: Experimental
description: In the laser group, the patients received two sessions of Er:YAG intraurethral laser in non-ablative SMOOTH™ mode, with 1 month interval between sessions.
arm group label: Tadalafil group
arm group type: Active Comparator
description: The tadalafil group was treated with daily oral administration of tadalafil, at a dose of 5 mg/day, which lasted consecutively for two months.
intervention type: Device
intervention name: non-ablative SMOOTH mode Erbium YAG laser
description: Erbium:YAG (Er:YAG) laser with non-ablative SMOOTH™ mode
arm group label: Laser group
intervention type: Drug
intervention name: Tadalafil 5mg
description: oral tadalafil 5 mg was administered daily over a period of two months
arm group label: Tadalafil group
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Argentina
responsible party type: Sponsor-Investigator
investigator affiliation: Espacio Gaspar Clinic
investigator full name: Adrian Gaspar
investigator title: Principal Investigator
mesh term: Prostatitis
mesh term: Syndrome
mesh term: Pelvic Pain
mesh term: Chronic Disease
mesh term: Tadalafil
sharing ipd: No