<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/NCT03043222</url>
  </required_header>
  <id_info>
    <org_study_id>27936</org_study_id>
    <nct_id>NCT03043222</nct_id>
  </id_info>
  <brief_title>Innovative Minimally Invasive Options in Treatment of Urinary Problems Related to Prostate Enlargement (BPH) in Men</brief_title>
  <official_title>Effect of Prostatic Urethral Lift (PUL) Versus Prostate Arterial Embolization (PAE),Novel Minimally Invasive Treatment Options on Health-related Quality of Life (HRQoL) in Men With Lower Urinary Tract Symptoms Secondary to BPH.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>St. Louis University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>St. Louis University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues:&#xD;
      the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing&#xD;
      ability to maintain normal sexual activity and function; both issues are important to men,&#xD;
      yet often the treatment of the former has adverse effects on the latter. Current medical and&#xD;
      surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery&#xD;
      times, degradation of sexual function and incontinence may negatively affect a patient's QoL.&#xD;
&#xD;
      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving&#xD;
      techniques with contrasting mechanisms of action (mechanical decompression vs angiographic&#xD;
      embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar&#xD;
      safety profiles. More importantly neither causes degradation of sexual function or urinary&#xD;
      continence. Although multiple studies are being reported on PUL and PAE alike, currently&#xD;
      there are no prospective clinical trials comparing these two technologies. We aim to&#xD;
      prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could&#xD;
      have a great impact on patient outcomes in men opting for minimally invasive, sexual function&#xD;
      sparing treatment options for symptom relief from prostate enlargement.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      As the population ages, there is a growing need to find ways for people to live longer with&#xD;
      satisfactory quality of life (QoL), even in the midst of increasing health problems. For the&#xD;
      ageing man, Health related quality of life ( HRQoL) is challenged by two common issues: the&#xD;
      onset of bothersome LUTS attributable to benign prostatic hypertrophy (BPH) and diminishing&#xD;
      ability to maintain normal sexual activity and function; both issues are important to men,&#xD;
      yet often the treatment of the former has adverse effects on the latter.&#xD;
&#xD;
      Current medical and surgical treatments like TURP for BPH offer symptomatic improvement of&#xD;
      LUTS but may adversely affect a patient's QOL and satisfaction. Peri-operative complications&#xD;
      and long recovery times, degradation of sexual function and iatrogenic incontinence may&#xD;
      negatively affect a patient's QoL overall, resulting in patient viewing this as a treatment&#xD;
      failure. Therefore when evaluating treatment options for BPH, treatment options with&#xD;
      important QOL measures of satisfaction have to be considered.&#xD;
&#xD;
      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving&#xD;
      techniques with contrasting mechanisms of action (mechanical decompression vs angiographic&#xD;
      embolization). Multiple prospective and retrospective studies have shown that both PUL and&#xD;
      PAE yield relief of lower urinary tract symptoms over a period of several weeks. They display&#xD;
      similar safety profiles with self-limiting pelvic discomfort characterizing the commonest&#xD;
      minor adverse event. Both procedures are minimally invasive and have the potential to be&#xD;
      carried out under local anesthesia and in the outpatient setting with suitability for&#xD;
      patients with cardiovascular comorbidities. Another important finding is that neither has&#xD;
      been found to cause degradation of sexual function.&#xD;
&#xD;
      Although there are an increasing number of data series being reported on PUL and PAE alike,&#xD;
      currently there are no prospective clinical trials comparing these two technologies. We aim&#xD;
      to prospectively evaluate and compare HRQol outcomes of PUL and PAE. All the endpoints will&#xD;
      be evaluated using validated questionnaires and laboratory values. Results of this study will&#xD;
      be transferable to clinical practice and could have a great impact on patient outcomes in men&#xD;
      opting for minimally invasive, sexual function sparing treatment options for symptom relief&#xD;
      from LUTS due to BPH in all practice settings.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Withdrawn from IRB&#xD;
  </why_stopped>
  <start_date type="Anticipated">March 1, 2018</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">April 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>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>Improvement in QOL</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Improvement in QOL score</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients with clinical adverse events</measure>
    <time_frame>1 day, 8 days and 1,3,6,12 months</time_frame>
    <description>Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post operative morbidity</measure>
    <time_frame>1 day, 8 days and 1 month</time_frame>
    <description>Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Recovery experience</measure>
    <time_frame>1 day, 8 days and 1 month</time_frame>
    <description>Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Improvement in symptoms of LUTS</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Reduction in International Prostate Symptom Score (IPSS) compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lack of change in sexual function</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lack of change in ejaculation during sex</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lack of change in urinary incontinence</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Change in Incontinence severity index (ISI) score</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Urinary flow after procedure</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Prostate volume after procedure</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Change in Prostate volume measured in cm3</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in residual urine left in bladder after procedure</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Change in Postvoid residual urine volume measured in ml</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Prostatic specific antigen (PSA) after procedure</measure>
    <time_frame>3,6,12 months</time_frame>
    <description>Change in PSA level measured in pg/ml</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Lower Urinary Tract Symptoms</condition>
  <condition>Benign Prostatic Hyperplasia</condition>
  <condition>Urinary Frequency/Urgency</condition>
  <condition>Urinary Incontinence, Urge</condition>
  <condition>Incontinence, Urinary</condition>
  <condition>Nocturia</condition>
  <arm_group>
    <arm_group_label>PAE-Prostate Arterial Embolization</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>PAE-Prostate Arterial Embolization</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PUL- Prostatic urethral lift</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PUL- Prostatic urethral lift</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UroLift as artifical device for prostatic urethral lift.</intervention_name>
    <description>UroLift as artifical device for prostatic urethral lift. The PUL treatment is a minimally invasive approach to treating an enlarged prostate, or BPH, that lifts or holds the enlarged prostate tissue using clips so that it is out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue.</description>
    <arm_group_label>PAE-Prostate Arterial Embolization</arm_group_label>
    <arm_group_label>PUL- Prostatic urethral lift</arm_group_label>
    <other_name>Prostatic urethral lift.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Embospheres Microspheres as embolic agents for prostate artery embolization</intervention_name>
    <description>Embospheres Microspheres as embolic agents for prostate artery embolization Arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery to the prostate gland.Small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the enlarged prostate. The prostate is then expected to shrink , thus relieving urinary symptoms related to prostate enlargement.There is no cutting or removal of prostate tissue.Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.</description>
    <arm_group_label>PAE-Prostate Arterial Embolization</arm_group_label>
    <arm_group_label>PUL- Prostatic urethral lift</arm_group_label>
    <other_name>Prostate artery embolization</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Male aged ≥40 yr Willing, able and mentally competent to provide written informed consent&#xD;
        and willing to comply with all study procedures and be available for the duration of the&#xD;
        study Diagnosis of urinary symptoms (LUTS) from prostatic enlargement (BPH) refractory to&#xD;
        medical therapy for at least 6 months.&#xD;
&#xD;
        International Prostate Symptom Score &gt;12&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PUL&#xD;
&#xD;
               1. Active urinary tract infections, prostatitis, or interstitial cystitis.&#xD;
&#xD;
               2. Biopsy proven prostate, bladder, or urethral cancer.&#xD;
&#xD;
                  The following patients must undergo prostate biopsy with a minimum of 12 cores&#xD;
                  and have a negative histopathology report to be enrolled in the study:&#xD;
&#xD;
                    -  Patients with digital rectal examination (DRE) findings suspicious for&#xD;
                       prostate cancer&#xD;
&#xD;
                    -  Patients with baseline PSA levels &gt; 10 ng/mL&#xD;
&#xD;
                    -  Patients with baseline PSA levels &gt;2.5 ng/mL and &lt; 10ng/mL AND free PSA &lt;&#xD;
                       25% of total PSA Patients with cystoscopy findings suspicious for bladder&#xD;
                       cancer must undergo biopsy and have a negative histopathology report to be&#xD;
                       enrolled in the study&#xD;
&#xD;
               3. Significant median lobe enlargement.&#xD;
&#xD;
               4. Large prostates, volume &gt;80 g.&#xD;
&#xD;
               5. Bladder atonia, neurogenic bladder disorder or other neurological disorder that&#xD;
                  is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease,&#xD;
                  spinal cord injuries, etc.)&#xD;
&#xD;
               6. Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder&#xD;
                  diverticulum, urinary obstruction due to causes other than BPH, or other&#xD;
                  potentially confounding bladder or urethral disease or condition&#xD;
&#xD;
               7. Urethral conditions that may prevent insertion of a rigid 20F cystoscope&#xD;
&#xD;
               8. Current urinary retention.&#xD;
&#xD;
               9. Acontractile detrusor.&#xD;
&#xD;
              10. Current gross hematuria&#xD;
&#xD;
              11. Known upper tract renal disease&#xD;
&#xD;
              12. Cystolithiasis&#xD;
&#xD;
              13. ASA &gt; 3 or severe medical debilitating condition&#xD;
&#xD;
              14. History of pelvic irradiation or radical pelvic surgery&#xD;
&#xD;
              15. Known allergy to nickel.&#xD;
&#xD;
                  PAE&#xD;
&#xD;
              16. Active urinary tract infections, prostatitis, or interstitial cystitis.&#xD;
&#xD;
              17. Biopsy proven prostate, bladder, or urethral cancer.&#xD;
&#xD;
                  The following patients must undergo prostate biopsy with a minimum of 12 cores&#xD;
                  and have a negative histopathology report to be enrolled in the study:&#xD;
&#xD;
                    -  Patients with digital rectal examination (DRE) findings suspicious for&#xD;
                       prostate cancer&#xD;
&#xD;
                    -  Patients with baseline PSA levels &gt; 10 ng/mL&#xD;
&#xD;
                    -  Patients with baseline PSA levels &gt;2.5 ng/mL and &lt; 10ng/mL AND free PSA &lt;&#xD;
                       25% of total PSA Patients with cystoscopy findings suspicious for bladder&#xD;
                       cancer must undergo biopsy and have a negative histopathology report to be&#xD;
                       enrolled in the study&#xD;
&#xD;
              18. Unable to have CT angio of the prostate imaging&#xD;
&#xD;
              19. Bladder atonia, neurogenic bladder disorder or other neurological disorder that&#xD;
                  is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease,&#xD;
                  spinal cord injuries, etc.)&#xD;
&#xD;
              20. Urethral stricture, bladder neck contracture, sphincter abnormalities, bladder&#xD;
                  diverticulum, urinary obstruction due to causes other than BPH, or other&#xD;
                  potentially confounding bladder or urethral disease or condition&#xD;
&#xD;
              21. Acontractile detrusor.&#xD;
&#xD;
              22. Known upper tract renal disease&#xD;
&#xD;
              23. Cystolithiasis&#xD;
&#xD;
              24. Any known condition that limits catheter-based intervention or is a&#xD;
                  contraindication to embolization, such as intolerance to a vessel occlusion&#xD;
                  procedure or severe atherosclerosis. Known major iliac arterial occlusive disease&#xD;
&#xD;
              25. ASA &gt; 3 or severe medical debilitating condition&#xD;
&#xD;
              26. Baseline serum creatinine level &gt; 1.8 mg/dl&#xD;
&#xD;
              27. Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease&#xD;
&#xD;
              28. History of pelvic irradiation or radical pelvic surgery&#xD;
&#xD;
              29. Allergy to iodinated contrast agents&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Keith Pereira, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Louis University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Beneranda Sophia Ford-Glanton, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Saint Louis University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Saint Louis University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <results_reference>
    <citation>McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.</citation>
    <PMID>21420124</PMID>
  </results_reference>
  <results_reference>
    <citation>Roehrborn CG, Rukstalis DB, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rashid P. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. 2015 Jun;22(3):7772-82.</citation>
    <PMID>26068624</PMID>
  </results_reference>
  <results_reference>
    <citation>Sonksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30.</citation>
    <PMID>25937539</PMID>
  </results_reference>
  <results_reference>
    <citation>Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, Pereira J, Oliveira AG. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up. Eur Radiol. 2013 Sep;23(9):2561-72. doi: 10.1007/s00330-012-2714-9. Epub 2013 Jan 31. Erratum In: Eur Radiol. 2013 Sep;23(9):2573-4.</citation>
    <PMID>23370938</PMID>
  </results_reference>
  <results_reference>
    <citation>Bagla S, Martin CP, van Breda A, Sheridan MJ, Sterling KM, Papadouris D, Rholl KS, Smirniotopoulos JB, van Breda A. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014 Jan;25(1):47-52. doi: 10.1016/j.jvir.2013.09.010. Epub 2013 Oct 28.</citation>
    <PMID>24176946</PMID>
  </results_reference>
  <results_reference>
    <citation>Uflacker AB, Haskal ZJ. Internal Iliac Artery Embolization for Benign Prostatic Hyperplasia? First Read the Fine Print. J Vasc Interv Radiol. 2015 Sep;26(9):1311-2. doi: 10.1016/j.jvir.2015.06.024. No abstract available.</citation>
    <PMID>26314640</PMID>
  </results_reference>
  <results_reference>
    <citation>Pisco JM, Bilhim T, Pinheiro LC, Fernandes L, Pereira J, Costa NV, Duarte M, Oliveira AG. Medium- and Long-Term Outcome of Prostate Artery Embolization for Patients with Benign Prostatic Hyperplasia: Results in 630 Patients. J Vasc Interv Radiol. 2016 Aug;27(8):1115-22. doi: 10.1016/j.jvir.2016.04.001. Epub 2016 Jun 16.</citation>
    <PMID>27321890</PMID>
  </results_reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 3, 2017</study_first_posted>
  <last_update_submitted>March 16, 2018</last_update_submitted>
  <last_update_submitted_qc>March 16, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 20, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>St. Louis University</investigator_affiliation>
    <investigator_full_name>Keith Pereira, MD:</investigator_full_name>
    <investigator_title>MD, Assistant professor, Interventional Radiology</investigator_title>
  </responsible_party>
  <keyword>prostate artery embolization</keyword>
  <keyword>Prostatic Urethral Lift, Urolift</keyword>
  <keyword>Minimally invasive</keyword>
  <keyword>non-surgical</keyword>
  <keyword>maintenance of sexual function</keyword>
  <keyword>complications of TURP , surgery</keyword>
  <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>Prostatic Hyperplasia</mesh_term>
    <mesh_term>Urinary Incontinence, Urge</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
    <mesh_term>Lower Urinary Tract Symptoms</mesh_term>
    <mesh_term>Nocturia</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/NCT03043222
org study id: 27936
nct id: NCT03043222
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
For ageing men, Health related quality of life ( HRQoL) is challenged by two common issues:
      the onset of bothersome urinary symptoms attributable to prostate enlargement and diminishing
      ability to maintain normal sexual activity and function; both issues are important to men,
      yet often the treatment of the former has adverse effects on the latter. Current medical and
      surgical treatments offer symptomatic improvement of urinary symptoms. However long recovery
      times, degradation of sexual function and incontinence may negatively affect a patient's QoL.

      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving
      techniques with contrasting mechanisms of action (mechanical decompression vs angiographic
      embolization). Both are minimally invasive, yield relief of urinary symptoms and have similar
      safety profiles. More importantly neither causes degradation of sexual function or urinary
      continence. Although multiple studies are being reported on PUL and PAE alike, currently
      there are no prospective clinical trials comparing these two technologies. We aim to
      prospectively evaluate and compare HRQol outcomes of PUL and PAE. Results of this study could
      have a great impact on patient outcomes in men opting for minimally invasive, sexual function
      sparing treatment options for symptom relief from prostate enlargement.
As the population ages, there is a growing need to find ways for people to live longer with
      satisfactory quality of life (QoL), even in the midst of increasing health problems. For the
      ageing man, Health related quality of life ( HRQoL) is challenged by two common issues: the
      onset of bothersome LUTS attributable to benign prostatic hypertrophy (BPH) and diminishing
      ability to maintain normal sexual activity and function; both issues are important to men,
      yet often the treatment of the former has adverse effects on the latter.

      Current medical and surgical treatments like TURP for BPH offer symptomatic improvement of
      LUTS but may adversely affect a patient's QOL and satisfaction. Peri-operative complications
      and long recovery times, degradation of sexual function and iatrogenic incontinence may
      negatively affect a patient's QoL overall, resulting in patient viewing this as a treatment
      failure. Therefore when evaluating treatment options for BPH, treatment options with
      important QOL measures of satisfaction have to be considered.

      Prostatic urethral lift (PUL) and prostate artery embolization (PAE) represent two evolving
      techniques with contrasting mechanisms of action (mechanical decompression vs angiographic
      embolization). Multiple prospective and retrospective studies have shown that both PUL and
      PAE yield relief of lower urinary tract symptoms over a period of several weeks. They display
      similar safety profiles with self-limiting pelvic discomfort characterizing the commonest
      minor adverse event. Both procedures are minimally invasive and have the potential to be
      carried out under local anesthesia and in the outpatient setting with suitability for
      patients with cardiovascular comorbidities. Another important finding is that neither has
      been found to cause degradation of sexual function.

      Although there are an increasing number of data series being reported on PUL and PAE alike,
      currently there are no prospective clinical trials comparing these two technologies. We aim
      to prospectively evaluate and compare HRQol outcomes of PUL and PAE. All the endpoints will
      be evaluated using validated questionnaires and laboratory values. Results of this study will
      be transferable to clinical practice and could have a great impact on patient outcomes in men
      opting for minimally invasive, sexual function sparing treatment options for symptom relief
      from LUTS due to BPH in all practice settings.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Improvement in QOL
time frame: 3,6,12 months
description: Improvement in QOL score
measure: Number of patients with clinical adverse events
time frame: 1 day, 8 days and 1,3,6,12 months
description: Short and medium term complications assessed by Clavien-Dindo Classification of Surgical Complications
measure: Post operative morbidity
time frame: 1 day, 8 days and 1 month
description: Morbidity (Intraprocedural and periprocedural data): Pain, hematuria, Procedure time, radiation parameters, duration of post procedure catheterization and hospitalization
measure: Recovery experience
time frame: 1 day, 8 days and 1 month
description: Recovery experience based on Quality of life (QoL) Visual Analog Scale( VAS)
measure: Improvement in symptoms of LUTS
time frame: 3,6,12 months
description: Reduction in International Prostate Symptom Score (IPSS) compared to baseline
measure: Lack of change in sexual function
time frame: 3,6,12 months
description: Reduction of Sexual Health Inventory For Men (SHIM) score compared to baseline
measure: Lack of change in ejaculation during sex
time frame: 3,6,12 months
description: Change in Male Sexual Health Questionnaire to assess ejaculatory dysfunction (MSHQ-EjD)
measure: Lack of change in urinary incontinence
time frame: 3,6,12 months
description: Change in Incontinence severity index (ISI) score
measure: Change in Urinary flow after procedure
time frame: 3,6,12 months
description: Change in Urinary maximal flow rate (Qmax) measured in ml/s on uroflowmetry.
measure: Change in Prostate volume after procedure
time frame: 3,6,12 months
description: Change in Prostate volume measured in cm3
measure: Change in residual urine left in bladder after procedure
time frame: 3,6,12 months
description: Change in Postvoid residual urine volume measured in ml
measure: Change in Prostatic specific antigen (PSA) after procedure
time frame: 3,6,12 months
description: Change in PSA level measured in pg/ml
arm group label: PAE-Prostate Arterial Embolization
arm group type: Experimental
description: PAE-Prostate Arterial Embolization
arm group label: PUL- Prostatic urethral lift
arm group type: Active Comparator
description: PUL- Prostatic urethral lift
intervention type: Device
intervention name: UroLift as artifical device for prostatic urethral lift.
description: UroLift as artifical device for prostatic urethral lift. The PUL treatment is a minimally invasive approach to treating an enlarged prostate, or BPH, that lifts or holds the enlarged prostate tissue using clips so that it is out of the way so it no longer blocks the urethra. There is no cutting, heating or removal of prostate tissue.
arm group label: PAE-Prostate Arterial Embolization
arm group label: PUL- Prostatic urethral lift
other name: Prostatic urethral lift.
intervention type: Device
intervention name: Embospheres Microspheres as embolic agents for prostate artery embolization
description: Embospheres Microspheres as embolic agents for prostate artery embolization Arterial access will be obtained.Under live X-ray monitoring and using contrast, a catheter will be advanced into the artery to the prostate gland.Small micro spherical particles (Embopheres Microspheres) will be injected though the catheter to occlude the artery and cut off blood supply to the enlarged prostate. The prostate is then expected to shrink , thus relieving urinary symptoms related to prostate enlargement.There is no cutting or removal of prostate tissue.Once the procedure is complete, in case of wrist access compression will be achieved with a band; in case of groin access a closure device will be used to plug the site of entry.
arm group label: PAE-Prostate Arterial Embolization
arm group label: PUL- Prostatic urethral lift
other name: Prostate artery embolization
criteria: 
gender: Male
minimum age: 40 Years
maximum age: N/A
healthy volunteers: No
last name: Keith Pereira, MD
role: Principal Investigator
affiliation: Saint Louis University Hospital
last name: Beneranda Sophia Ford-Glanton, MD
role: Principal Investigator
affiliation: Saint Louis University Hospital
facility: 
country: United States
citation: McVary KT, Roehrborn CG, Avins AL, Barry MJ, Bruskewitz RC, Donnell RF, Foster HE Jr, Gonzalez CM, Kaplan SA, Penson DF, Ulchaker JC, Wei JT. Update on AUA guideline on the management of benign prostatic hyperplasia. J Urol. 2011 May;185(5):1793-803. doi: 10.1016/j.juro.2011.01.074. Epub 2011 Mar 21.
PMID: 21420124
citation: Roehrborn CG, Rukstalis DB, Barkin J, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Cantwell AL, McVary KT, Te AE, Gholami SS, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rashid P. Three year results of the prostatic urethral L.I.F.T. study. Can J Urol. 2015 Jun;22(3):7772-82.
PMID: 26068624
citation: Sonksen J, Barber NJ, Speakman MJ, Berges R, Wetterauer U, Greene D, Sievert KD, Chapple CR, Montorsi F, Patterson JM, Fahrenkrug L, Schoenthaler M, Gratzke C. Prospective, randomized, multinational study of prostatic urethral lift versus transurethral resection of the prostate: 12-month results from the BPH6 study. Eur Urol. 2015 Oct;68(4):643-52. doi: 10.1016/j.eururo.2015.04.024. Epub 2015 Apr 30.
PMID: 25937539
citation: Pisco JM, Rio Tinto H, Campos Pinheiro L, Bilhim T, Duarte M, Fernandes L, Pereira J, Oliveira AG. Embolisation of prostatic arteries as treatment of moderate to severe lower urinary symptoms (LUTS) secondary to benign hyperplasia: results of short- and mid-term follow-up. Eur Radiol. 2013 Sep;23(9):2561-72. doi: 10.1007/s00330-012-2714-9. Epub 2013 Jan 31. Erratum In: Eur Radiol. 2013 Sep;23(9):2573-4.
PMID: 23370938
citation: Bagla S, Martin CP, van Breda A, Sheridan MJ, Sterling KM, Papadouris D, Rholl KS, Smirniotopoulos JB, van Breda A. Early results from a United States trial of prostatic artery embolization in the treatment of benign prostatic hyperplasia. J Vasc Interv Radiol. 2014 Jan;25(1):47-52. doi: 10.1016/j.jvir.2013.09.010. Epub 2013 Oct 28.
PMID: 24176946
citation: Uflacker AB, Haskal ZJ. Internal Iliac Artery Embolization for Benign Prostatic Hyperplasia? First Read the Fine Print. J Vasc Interv Radiol. 2015 Sep;26(9):1311-2. doi: 10.1016/j.jvir.2015.06.024. No abstract available.
PMID: 26314640
citation: Pisco JM, Bilhim T, Pinheiro LC, Fernandes L, Pereira J, Costa NV, Duarte M, Oliveira AG. Medium- and Long-Term Outcome of Prostate Artery Embolization for Patients with Benign Prostatic Hyperplasia: Results in 630 Patients. J Vasc Interv Radiol. 2016 Aug;27(8):1115-22. doi: 10.1016/j.jvir.2016.04.001. Epub 2016 Jun 16.
PMID: 27321890
responsible party type: Principal Investigator
investigator affiliation: St. Louis University
investigator full name: Keith Pereira, MD:
investigator title: MD, Assistant professor, Interventional Radiology
mesh term: Urinary Incontinence
mesh term: Enuresis
mesh term: Prostatic Hyperplasia
mesh term: Urinary Incontinence, Urge
mesh term: Hyperplasia
mesh term: Lower Urinary Tract Symptoms
mesh term: Nocturia
sharing ipd: No