PUL vs TURP in BPH Patients With Urinary Retention

NCT06037356 | Recruiting FDA Device

• 1 other identifier: QMH PULTUR Study
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

BPH With Urinary Obstruction

Keywords

BPH; Urinary retention; prostatic urethral lift; PUL; TURP

Outcome Measures

Primary Outcomes (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

  1 year after intervention

Secondary Outcomes (12)

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

  5 years

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

  1 year

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

  1 year

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

  1 year

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

  1 year

Study Arms (2)

Prostatic Urethral Lift

EXPERIMENTAL

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.

Device: Prostatic Urethral Lift

TURP

ACTIVE COMPARATOR

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

Procedure: TURP

Interventions

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

Also known as: PUL, Urolift

Prostatic Urethral Lift

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

Also known as: Transurethral resection of prostate

TURP

Eligibility Criteria

• Age: 40 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen Mary Hospital, Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, China

RECRUITING

Related Publications (11)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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.

  PMID: 11908420 BACKGROUND

• 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.

  PMID: 9126073 BACKGROUND

• 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.

  PMID: 21554526 BACKGROUND

• 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.

  PMID: 28646943 BACKGROUND

• 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.

  PMID: 31115257 BACKGROUND

• 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.

  PMID: 28646935 BACKGROUND

• 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.

  PMID: 24119101 BACKGROUND

• 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.

  PMID: 30283994 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Brian SH Ho, MBBS

  Queen Mary Hospital, Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Brian SH Ho, MBBS

CONTACT

(852)2255-3023; hobrian@hku.hk

Stacia Chun, BSc(Hons)

CONTACT

(852)2255-4852; stac@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Consultant

Model Details: 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.

Study Record Dates

• First Submitted: April 26, 2023
• First Posted: September 14, 2023
• Study Start: January 1, 2025
• Primary Completion (Estimated): May 30, 2035
• Study Completion (Estimated): May 30, 2035
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)