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PUL vs TURP in BPH Patients With Urinary Retention (PULTUR)

Primary Purpose

BPH With Urinary Obstruction

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Prostatic Urethral Lift
TURP
Sponsored by
Queen Mary Hospital, Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BPH With Urinary Obstruction focused on measuring BPH, Urinary retention, prostatic urethral lift, PUL, TURP

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

Inclusion Criteria: Male patients age >40 years old urinary retention who failed trial without catheter Exclusion Criteria: Inability to provide consent OR no guardians or relatives to help provide consent on patient's behalf Active urinary tract infection Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostatic urethral lift, etc.) Bladder stones Urethral strictures or bladder neck contractures Prostate size >100mL Solely obstructing median lobe Urinary retention not due to obstruction (i.e., Bladder outflow obstruction index <20 on urodynamic studies) Poor detrusor contractility (maximum detrusor pressure <20cmH2O during voiding phase) Anticoagulant or antiplatelet agents that cannot be stopped

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Prostatic Urethral Lift

    TURP

    Arm 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.

    Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.

    Outcomes

    Primary Outcome Measures

    Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention
    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

    Secondary Outcome Measures

    Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention
    To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)
    Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention
    To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)
    Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP
    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
    Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP
    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
    Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP
    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
    Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP
    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
    Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP
    Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention.
    Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP
    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
    Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP
    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
    Compare patient reported recovery by VAS after prostatic urethral lift versus TURP
    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
    Compare improvement bladder contractility index after prostatic urethral lift versus TURP
    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
    Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP
    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

    Full Information

    First Posted
    April 26, 2023
    Last Updated
    September 7, 2023
    Sponsor
    Queen Mary Hospital, Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06037356
    Brief Title
    PUL vs TURP in BPH Patients With Urinary Retention
    Acronym
    PULTUR
    Official Title
    Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 1, 2023 (Anticipated)
    Primary Completion Date
    September 30, 2030 (Anticipated)
    Study Completion Date
    September 30, 2031 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Queen Mary Hospital, Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Product Manufactured in and Exported from the U.S.
    Yes
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    BPH With Urinary Obstruction
    Keywords
    BPH, Urinary retention, prostatic urethral lift, PUL, TURP

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    100 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Prostatic Urethral Lift
    Arm Type
    Experimental
    Arm 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 Title
    TURP
    Arm Type
    Active Comparator
    Arm Description
    Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.
    Intervention Type
    Device
    Intervention Name(s)
    Prostatic Urethral Lift
    Other Intervention Name(s)
    PUL, Urolift
    Intervention 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
    Intervention Type
    Procedure
    Intervention Name(s)
    TURP
    Other Intervention Name(s)
    Transurethral resection of prostate
    Intervention 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
    Primary Outcome Measure Information:
    Title
    Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention
    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
    Time Frame
    1 year after intervention
    Secondary Outcome Measure Information:
    Title
    Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention
    Description
    To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)
    Time Frame
    5 years
    Title
    Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention
    Description
    To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)
    Time Frame
    1 year
    Title
    Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP
    Description
    Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention.
    Time Frame
    1 year
    Title
    Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare patient reported recovery by VAS after prostatic urethral lift versus TURP
    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
    Time Frame
    1 year
    Title
    Compare improvement bladder contractility index after prostatic urethral lift versus TURP
    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
    Time Frame
    5 year
    Title
    Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP
    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
    Time Frame
    5 year

    10. Eligibility

    Sex
    Male
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Male patients age >40 years old urinary retention who failed trial without catheter Exclusion Criteria: Inability to provide consent OR no guardians or relatives to help provide consent on patient's behalf Active urinary tract infection Previous surgical treatment for benign prostatic hyperplasia (i.e., TURP, prostatic urethral lift, etc.) Bladder stones Urethral strictures or bladder neck contractures Prostate size >100mL Solely obstructing median lobe Urinary retention not due to obstruction (i.e., Bladder outflow obstruction index <20 on urodynamic studies) Poor detrusor contractility (maximum detrusor pressure <20cmH2O during voiding phase) Anticoagulant or antiplatelet agents that cannot be stopped
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Brian SH Ho, MBBS
    Phone
    (852)2255-3023
    Email
    hobrian@hku.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Stacia Chun, BSc(Hons)
    Phone
    (852)2255-4852
    Email
    stac@hku.hk
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Brian SH Ho, MBBS
    Organizational Affiliation
    Queen Mary Hospital, Hong Kong
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    1714529
    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.
    Results Reference
    background
    PubMed Identifier
    10492184
    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.
    Results Reference
    background
    PubMed Identifier
    10233485
    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.
    Results Reference
    background
    PubMed Identifier
    11908420
    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.
    Results Reference
    background
    PubMed Identifier
    9126073
    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.
    Results Reference
    background
    PubMed Identifier
    21554526
    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.
    Results Reference
    background
    PubMed Identifier
    28646943
    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.
    Results Reference
    background
    PubMed Identifier
    31115257
    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.
    Results Reference
    result
    PubMed Identifier
    28646935
    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.
    Results Reference
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    PubMed Identifier
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    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.
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    Citation
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    Results Reference
    result
    Links:
    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

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