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BPH With Urinary ObstructionPULTURNCT06037356

PUL vs TURP in BPH Patients With Urinary Retention

A study testing Prostatic Urethral Lift and TURP in people with BPH With Urinary Obstruction, run by Queen Mary Hospital, Hong Kong at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 years and older, men only
Conditions the study is for
BPH With Urinary Obstruction
What is being tested?
Prostatic Urethral Lift and TURP
Could I receive a placebo?
No, everyone receives an active treatment
How many people
100 participants
Where
1 siteChina
Study dates
1 Jan 2025to 30 May 2035
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • Men only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male patients
  • age >40 years old
  • urinary retention who failed trial without catheter

Who cannot join

  • 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
Show all 10Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Brian SH Ho, MBBS contact

(852)2255-3023

hobrian@hku.hk

Stacia Chun, BSc(Hons) contact

(852)2255-4852

stac@hku.hk

China1 site, 1 recruiting
  • Queen Mary Hospital

    Hong Kong

    Brian SH Ho, MBBS, (852)2255-3023, brianshho@gmail.com

    Sau Loi Ng, BN, DN, (852)2255-3625, ngsauloi2009@gmail.com

    Recruiting

Other trials in China

About this study

Official title: Prostatic Urethral Lift Versus Transurethral Resection of Prostate in Benign Prostatic Hyperplasia Patients With Urinary Retention

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.

Read the 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.

Being tested
Prostatic Urethral Lift, TURP
Keywords
BPH, Urinary retention, prostatic urethral lift, PUL, TURP
Medical subject headings
Urinary Retention

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prostatic Urethral LiftDevice

    Also called PUL, Urolift

    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

  • TURPProcedure or surgery

    Also called Transurethral resection of prostate

    Using monopolar or bipolar loop diathermy via cystoscopy, excess prostate tissue is resected piecemeal to remove obstruction to the prostatic urethra due to BPH

Study groups in NCT06037356
Study groupRoleWhat they receive
Prostatic Urethral LiftExperimentalProstatic 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.
Receives: Device: Prostatic Urethral Lift
TURPActive comparatorTransurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.
Receives: Procedure: TURP

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: 1 year after intervention

Secondary outcomes (12)
  1. 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)

    Measured: 5 years

  2. 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)

    Measured: 1 year

  3. 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

    Measured: 1 year

  4. 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

    Measured: 1 year

  5. 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

    Measured: 1 year

  6. 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

    Measured: 1 year

  7. 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.

    Measured: 1 year

  8. 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

    Measured: 1 year

  9. 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

    Measured: 1 year

  10. 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

    Measured: 1 year

  11. 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

    Measured: 5 year

  12. 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

    Measured: 5 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Sep 2023
  2. Study start1 Jan 2025
  3. Primary completion30 May 2035 (estimated)
  4. Study completion30 May 2035 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06037356
Sponsor's protocol ID
QMH PULTUR Study
Acronym
PULTUR
Status last verified
Jul 2025
First submitted
26 Apr 2023
Last updated
24 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 1714529
  • 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.

    PubMed 10492184
  • 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.

    PubMed 10233485
  • 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.

    PubMed 11908420
  • 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.

    PubMed 9126073
  • 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.

    PubMed 21554526
  • 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.

    PubMed 28646943
  • 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.

    PubMed 31115257
  • 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.

    PubMed 28646935
  • 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.

    PubMed 24119101
  • 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.

    PubMed 30283994

Questions about this trial

What is this clinical trial studying?

A study testing Prostatic Urethral Lift and TURP in people with BPH With Urinary Obstruction, run by Queen Mary Hospital, Hong Kong at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Brian SH Ho, MBBS ((852)2255-3023, hobrian@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Catheter-free rates after prostatic urethral lift versus TURP in BPH patients with urinary retention (time frame: 1 year after intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06037356, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.

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