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NCT Number: NCT06037356

PUL vs TURP in BPH 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.

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Key information

Conditions

BPH With Urinary Obstruction Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

40 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostatic Urethral Lift

Device

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

Other names: PUL, Urolift

TURP

Procedure

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

Other names: Transurethral resection of prostate

Primary outcomes

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

    Time frame: 1 year after intervention

    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 outcomes

  1. Compare complication rate of prostatic urethral lift versus TURP in BPH patients with urinary retention

    Time frame: 5 years

    To determine the percentage and severity of complications after each intervention (according to the Clavien-Dindo classification)

  2. Cost effectiveness of prostatic urethral lift versus TURP in achieving catheter-free rates in BPH patients with urinary retention

    Time frame: 1 year

    To determine the cost required to achieve catheter free patients for each intervention (including hospitalization, anesthetic costs, equipment, consumables, etc)

  3. Compare patient satisfaction by PGI-I questionnaire after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  4. Compare patient reported symptom measures by IPSS questionnaire after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  5. Compare patient reported symptom measures by ISI questionnaire after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  6. Compare patient reported symptom measures by IIEF-5 questionnaire after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  7. Compare patient reported symptom measures by MSHQ-EjD short form questionnaire after prostatic urethral lift versus TURP

    Time frame: 1 year

    Using the Male Sexual Health Questionnaire for Ejaculatory Dysfunction (MSHQ-EjD) short form questionnaire to determine patient reported symptom measure after each intervention.

  8. Compare patient reported quality of life by SF-12 questionnaire after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  9. Compare patient reported quality of life by derived SF-6D utility score after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  10. Compare patient reported recovery by VAS after prostatic urethral lift versus TURP

    Time frame: 1 year

    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

  11. Compare improvement bladder contractility index after prostatic urethral lift versus TURP

    Time frame: 5 year

    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

  12. Compare improvement of Bladder outflow obstruction index after prostatic urethral lift versus TURP

    Time frame: 5 year

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Brian SH Ho, MBBS

CONTACT

[email protected]

(852)2255-3023

Stacia Chun, BSc(Hons)

CONTACT

[email protected]

(852)2255-4852

Sponsors and collaborators

Lead sponsor

Queen Mary Hospital, Hong Kong

Other

Registry information

Official study title

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

Acronym: PULTUR

Important dates

Study start
2025
Primary completion
2035
Study completion
2035
First posted
Sep 14, 2023
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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