xml: <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/NCT06037356</url>
    </required_header>
    <id_info>
      <org_study_id>QMH PULTUR Study</org_study_id>
      <nct_id>NCT06037356</nct_id>
    </id_info>
    <brief_title>PUL vs TURP in BPH Patients With Urinary Retention</brief_title>
    <acronym>PULTUR</acronym>
    <official_title>Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Queen Mary Hospital, Hong Kong</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Queen Mary Hospital, Hong Kong</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_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The study will be a prospective, randomized controlled trial comparing prostatic urethral&#xD;
        lift (PUL) versus transurethral resection of prostate (TURP) in benign prostate hyperplasia&#xD;
        (BPH) patients with urinary retention. The primary objective of this study is to compare the&#xD;
        catheter-free rates of PUL vs TURP. Secondary objectives include comparison of complications&#xD;
        rates, cost effectiveness, patient satisfactory, symptom scores, quality of life measures and&#xD;
        urodynamic parameters.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The study will be a prospective, non-inferiority randomized controlled trial with the aim of&#xD;
        detecting a non-inferiority margin of 5%.&#xD;
  &#xD;
        After the potential subject has been informed of the study and the potential risks, he will&#xD;
        be screened for eligibility within a 4 week period. Assessment of eligibility will include&#xD;
        questionnaires, blood tests, urine tests, uroflowmetry, flexible cystoscopy, transrectal&#xD;
        ultrasound, and urodynamic study. Suitable subjects will then be randomized in a 1:1 ratio to&#xD;
        the prostatic urethral lift (intervention group) and TURP (control group). Patients in the&#xD;
        prostatic urethral lift will have the procedure performed under local anesthesia or monitored&#xD;
        anesthetic care while TURP patients will be performed under spinal or general anesthesia. The&#xD;
        subjects will have regular follow up 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4&#xD;
        years, and 5 years post-operatively. Follow up assessments will include questionnaires,&#xD;
        uroflowmetry, and occasional urodynamic study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2031</completion_date>
    <primary_completion_date type="Anticipated">September 30, 2030</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>The study will be a prospective, non-inferiority randomized controlled trial with the aim of detecting a non-inferiority margin of 5%. Subjects will be randomized in a 1:1 ratio.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention</measure>
      <time_frame>1 year after intervention</time_frame>
      <description>To determine how many patients will be catheter-free (defined as by the ability to void with a post-void residual urine &lt;300mL) after intervention and remain catheter-free at 1 month, 3 months, and 1 year after intervention</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention</measure>
      <time_frame>5 years</time_frame>
      <description>To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention</measure>
      <time_frame>1 year</time_frame>
      <description>To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Patient global impression of improvement (PGI-I) questionnaire to determine patient satisfaction after each intervention.&#xD;
  minimum score is 1, maximum score is 7&#xD;
  higher score means worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention&#xD;
  minimal score: 0, maximum score is 35&#xD;
  higher score means worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Incontinence severity index (ISI) questionnaire to determine patient reported symptom measure after each intervention&#xD;
  minimum score: 1, maximum score: 12&#xD;
  higher score means worse outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention&#xD;
  minimum score: 1, maximum score: 25&#xD;
  higher score means better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention&#xD;
  minimum score: 0, maximum score: 100&#xD;
  higher score means better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the derived Short Form 6 Dimension (SF-6D) utility score questionnaire to determine patient reported quality of life measures after each intervention&#xD;
  minimum score: 0, maximum score 1.0&#xD;
  higher score means better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare patient reported recovery by VAS after prostatic urethral lift versus TURP</measure>
      <time_frame>1 year</time_frame>
      <description>Using the Visual analogue scale of quality of recovery to determine patient reported recovery after each intervention&#xD;
  minimum score: 0, maximum score 100&#xD;
  higher score means better outcome</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare improvement bladder contractility index after prostatic urethral lift versus TURP</measure>
      <time_frame>5 year</time_frame>
      <description>Pre- and post-intervention urodynamic will be performed to assess bladder contractility index as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP</measure>
      <time_frame>5 year</time_frame>
      <description>Pre- and post-intervention urodynamic will be performed to assess bladder outflow obstruction index (BOOI) as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">100</enrollment>
    <condition>BPH With Urinary Obstruction</condition>
    <arm_group>
      <arm_group_label>Prostatic Urethral Lift</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Prostatic urethral lift implants will be placed in patients under local anesthesia or monitored anesthetic care. The number of implants used will depend on intra-operative findings, ranging from 2 to 8 implants per patient.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>TURP</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Prostatic Urethral Lift</intervention_name>
      <description>Prostatic urethral lift uses permanent implants to retract the prostate lobes away from the prostate urethra to allow unobstructed passage of urine. These implants are made of Nitinol, non-absorbable monofilament suture material (Poly Ethylene Terephthalate), Stainless Steel</description>
      <arm_group_label>Prostatic Urethral Lift</arm_group_label>
      <other_name>PUL</other_name>
      <other_name>Urolift</other_name>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>TURP</intervention_name>
      <description>Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH</description>
      <arm_group_label>TURP</arm_group_label>
      <other_name>Transurethral resection of prostate</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Male patients&#xD;
  &#xD;
            -  age &gt;40 years old&#xD;
  &#xD;
            -  urinary retention who failed trial without catheter&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Inability to provide consent OR no guardians or relatives to help provide consent on&#xD;
               patient's behalf&#xD;
  &#xD;
            -  Active urinary tract infection&#xD;
  &#xD;
            -  Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostatic&#xD;
               urethral lift, etc.)&#xD;
  &#xD;
            -  Bladder stones&#xD;
  &#xD;
            -  Urethral strictures or bladder neck contractures&#xD;
  &#xD;
            -  Prostate size &gt;100mL&#xD;
  &#xD;
            -  Solely obstructing median lobe&#xD;
  &#xD;
            -  Urinary retention not due to obstruction (i.e., Bladder outflow obstruction index &lt;20&#xD;
               on urodynamic studies)&#xD;
  &#xD;
            -  Poor detrusor contractility (maximum detrusor pressure &lt;20cmH2O during voiding phase)&#xD;
  &#xD;
            -  Anticoagulant or antiplatelet agents that cannot be stopped&#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>Brian SH Ho, MBBS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Queen Mary Hospital, Hong Kong</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Brian SH Ho, MBBS</last_name>
      <phone>(852)2255-3023</phone>
      <email>hobrian@hku.hk</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Stacia Chun, BSc(Hons)</last_name>
      <phone>(852)2255-4852</phone>
      <email>stac@hku.hk</email>
    </overall_contact_backup>
    <link>
      <url>http://www.bycensus2016.gov.hk/en/Snapshot-01.html</url>
      <description>2016 Hong Kong Population By-census results reveal latest demographic trends [Internet]. Census and Statistics Department</description>
    </link>
    <reference>
      <citation>Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.</citation>
      <PMID>1714529</PMID>
    </reference>
    <reference>
      <citation>Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.</citation>
      <PMID>10492184</PMID>
    </reference>
    <reference>
      <citation>Madersbacher S, Marberger M. Is transurethral resection of the prostate still justified? BJU Int. 1999 Feb;83(3):227-37. doi: 10.1046/j.1464-410x.1999.00908.x. No abstract available.</citation>
      <PMID>10233485</PMID>
    </reference>
    <reference>
      <citation>Mebust WK, Holtgrewe HL, Cockett AT, Peters PC. Transurethral prostatectomy: immediate and postoperative complications. a cooperative study of 13 participating institutions evaluating 3,885 patients. 1989. J Urol. 2002 Feb;167(2 Pt 2):999-1003; discussion 1004. No abstract available.</citation>
      <PMID>11908420</PMID>
    </reference>
    <reference>
      <citation>Neal DE. The National Prostatectomy Audit. Br J Urol. 1997 Apr;79 Suppl 2:69-75. doi: 10.1111/j.1464-410x.1997.tb16924.x. No abstract available.</citation>
      <PMID>9126073</PMID>
    </reference>
    <reference>
      <citation>Woo HH, Chin PT, McNicholas TA, Gill HS, Plante MK, Bruskewitz RC, Roehrborn CG. Safety and feasibility of the prostatic urethral lift: a novel, minimally invasive treatment for lower urinary tract symptoms (LUTS) secondary to benign prostatic hyperplasia (BPH). BJU Int. 2011 Jul;108(1):82-8. doi: 10.1111/j.1464-410X.2011.10342.x. Epub 2011 May 6.</citation>
      <PMID>21554526</PMID>
    </reference>
    <reference>
      <citation>Walsh LP. State of the art: Advanced techniques for prostatic urethral lift for the relief of prostate obstruction under local anesthesia. Can J Urol. 2017 Jun;24(3):8859-8864.</citation>
      <PMID>28646943</PMID>
    </reference>
    <results_reference>
      <citation>Eure G, Gange S, Walter P, Khan A, Chabert C, Mueller T, Cozzi P, Patel M, Freedman S, Chin P, Ochs S, Hirsh A, Trotter M, Grier D. Real-World Evidence of Prostatic Urethral Lift Confirms Pivotal Clinical Study Results: 2-Year Outcomes of a Retrospective Multicenter Study. J Endourol. 2019 Jul;33(7):576-584. doi: 10.1089/end.2019.0167. Epub 2019 Jun 25.</citation>
      <PMID>31115257</PMID>
    </results_reference>
    <results_reference>
      <citation>Roehrborn CG, 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, Herron S, Rashid P, Rukstalis DB. Five year results of the prospective randomized controlled prostatic urethral L.I.F.T. study. Can J Urol. 2017 Jun;24(3):8802-8813.</citation>
      <PMID>28646935</PMID>
    </results_reference>
    <results_reference>
      <citation>McVary KT, Gange SN, Shore ND, Bolton DM, Cowan BE, Brown BT, Te AE, Chin PT, Rukstalis DB, Roehrborn CG; L.I.F.T. Study Investigators. Treatment of LUTS secondary to BPH while preserving sexual function: randomized controlled study of prostatic urethral lift. J Sex Med. 2014 Jan;11(1):279-87. doi: 10.1111/jsm.12333. Epub 2013 Sep 30.</citation>
      <PMID>24119101</PMID>
    </results_reference>
    <results_reference>
      <citation>Sievert KD, Schonthaler M, Berges R, Toomey P, Drager D, Herlemann A, Miller F, Wetterauer U, Volkmer B, Gratzke C, Amend B. Minimally invasive prostatic urethral lift (PUL) efficacious in TURP candidates: a multicenter German evaluation after 2 years. World J Urol. 2019 Jul;37(7):1353-1360. doi: 10.1007/s00345-018-2494-1. Epub 2018 Oct 3.</citation>
      <PMID>30283994</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>April 26, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Queen Mary Hospital, Hong Kong</investigator_affiliation>
      <investigator_full_name>Brian Ho</investigator_full_name>
      <investigator_title>Associate Consultant</investigator_title>
    </responsible_party>
    <keyword>BPH</keyword>
    <keyword>Urinary retention</keyword>
    <keyword>prostatic urethral lift</keyword>
    <keyword>PUL</keyword>
    <keyword>TURP</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Urinary Retention</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06037356
  org study id: QMH PULTUR Study
  nct id: NCT06037356
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: Yes
  is us export: Yes
  The study will be a prospective, randomized controlled trial comparing prostatic urethral
        lift (PUL) versus transurethral resection of prostate (TURP) in benign prostate hyperplasia
        (BPH) patients with urinary retention. The primary objective of this study is to compare the
        catheter-free rates of PUL vs TURP. Secondary objectives include comparison of complications
        rates, cost effectiveness, patient satisfactory, symptom scores, quality of life measures and
        urodynamic parameters.
  The study will be a prospective, non-inferiority randomized controlled trial with the aim of
        detecting a non-inferiority margin of 5%.
  
        After the potential subject has been informed of the study and the potential risks, he will
        be screened for eligibility within a 4 week period. Assessment of eligibility will include
        questionnaires, blood tests, urine tests, uroflowmetry, flexible cystoscopy, transrectal
        ultrasound, and urodynamic study. Suitable subjects will then be randomized in a 1:1 ratio to
        the prostatic urethral lift (intervention group) and TURP (control group). Patients in the
        prostatic urethral lift will have the procedure performed under local anesthesia or monitored
        anesthetic care while TURP patients will be performed under spinal or general anesthesia. The
        subjects will have regular follow up 1 month, 3 months, 6 months, 1 year, 2 years, 3 years, 4
        years, and 5 years post-operatively. Follow up assessments will include questionnaires,
        uroflowmetry, and occasional urodynamic study.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: The study will be a prospective, non-inferiority randomized controlled trial with the aim of detecting a non-inferiority margin of 5%. Subjects will be randomized in a 1:1 ratio.
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention
  time frame: 1 year after intervention
  description: To determine how many patients will be catheter-free (defined as by the ability to void with a post-void residual urine <300mL) after intervention and remain catheter-free at 1 month, 3 months, and 1 year after intervention
  measure: Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention
  time frame: 5 years
  description: To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)
  measure: Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention
  time frame: 1 year
  description: To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)
  measure: Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the Patient global impression of improvement (PGI-I) questionnaire to determine patient satisfaction after each intervention.
  minimum score is 1, maximum score is 7
  higher score means worse outcome
  measure: Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using International prostate symptom score (IPSS) questionnaire to determine patient reported symptom measure after each intervention
  minimal score: 0, maximum score is 35
  higher score means worse outcome
  measure: Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the Incontinence severity index (ISI) questionnaire to determine patient reported symptom measure after each intervention
  minimum score: 1, maximum score: 12
  higher score means worse outcome
  measure: Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the International index of erectile function- 5 items (IIEF-5) questionnaire to determine patient reported symptom measure after each intervention
  minimum score: 1, maximum score: 25
  higher score means better outcome
  measure: Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention.
  measure: Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the Short Form 12 (SF-12) questionnaire to determine patient reported quality of life measures after each intervention
  minimum score: 0, maximum score: 100
  higher score means better outcome
  measure: Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the derived Short Form 6 Dimension (SF-6D) utility score questionnaire to determine patient reported quality of life measures after each intervention
  minimum score: 0, maximum score 1.0
  higher score means better outcome
  measure: Compare patient reported recovery by VAS after prostatic urethral lift versus TURP
  time frame: 1 year
  description: Using the Visual analogue scale of quality of recovery to determine patient reported recovery after each intervention
  minimum score: 0, maximum score 100
  higher score means better outcome
  measure: Compare improvement bladder contractility index after prostatic urethral lift versus TURP
  time frame: 5 year
  description: Pre- and post-intervention urodynamic will be performed to assess bladder contractility index as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention
  measure: Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP
  time frame: 5 year
  description: Pre- and post-intervention urodynamic will be performed to assess bladder outflow obstruction index (BOOI) as well as subsequent improvement and durability of above stated urodynamic parameter after each intervention
  arm group label: Prostatic Urethral Lift
  arm group type: Experimental
  description: Prostatic urethral lift implants will be placed in patients under local anesthesia or monitored anesthetic care. The number of implants used will depend on intra-operative findings, ranging from 2 to 8 implants per patient.
  arm group label: TURP
  arm group type: Active Comparator
  description: Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.
  intervention type: Device
  intervention name: Prostatic Urethral Lift
  description: Prostatic urethral lift uses permanent implants to retract the prostate lobes away from the prostate urethra to allow unobstructed passage of urine. These implants are made of Nitinol, non-absorbable monofilament suture material (Poly Ethylene Terephthalate), Stainless Steel
  arm group label: Prostatic Urethral Lift
  other name: PUL
  other name: Urolift
  intervention type: Procedure
  intervention name: TURP
  description: Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH
  arm group label: TURP
  other name: Transurethral resection of prostate
  criteria: 
  gender: Male
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Brian SH Ho, MBBS
  role: Principal Investigator
  affiliation: Queen Mary Hospital, Hong Kong
  last name: Brian SH Ho, MBBS
  phone: (852)2255-3023
  email: hobrian@hku.hk
  last name: Stacia Chun, BSc(Hons)
  phone: (852)2255-4852
  email: stac@hku.hk
  url: http://www.bycensus2016.gov.hk/en/Snapshot-01.html
  description: 2016 Hong Kong Population By-census results reveal latest demographic trends [Internet]. Census and Statistics Department
  citation: Garraway WM, Collins GN, Lee RJ. High prevalence of benign prostatic hypertrophy in the community. Lancet. 1991 Aug 24;338(8765):469-71. doi: 10.1016/0140-6736(91)90543-x.
  PMID: 1714529
  citation: Jacobsen SJ, Jacobson DJ, Girman CJ, Roberts RO, Rhodes T, Guess HA, Lieber MM. Treatment for benign prostatic hyperplasia among community dwelling men: the Olmsted County study of urinary symptoms and health status. J Urol. 1999 Oct;162(4):1301-6.
  PMID: 10492184
  citation: Madersbacher S, Marberger M. Is transurethral resection of the prostate still justified? BJU Int. 1999 Feb;83(3):227-37. doi: 10.1046/j.1464-410x.1999.00908.x. No abstract available.
  PMID: 10233485
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  PMID: 30283994
  responsible party type: Principal Investigator
  investigator affiliation: Queen Mary Hospital, Hong Kong
  investigator full name: Brian Ho
  investigator title: Associate Consultant
  mesh term: Urinary Retention
  sharing ipd: No