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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: BPH With Urinary Obstruction
• Intervention / Treatment: Device: Prostatic Urethral Lift; Procedure: TURP

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.

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian SH Ho, MBBS; Phone Number: (852)2255-3023; Email: hobrian@hku.hk
• Study Contact Backup: Name: Stacia Chun, BSc(Hons); Phone Number: (852)2255-4852; Email: stac@hku.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Prostatic Urethral Lift; 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; 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
Active Comparator: TURP; Transurethral resection of prostate (TURP) will be performed under spinal or general anesthesia as per usual care.	Procedure: TURP; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	5 years
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)	1 year
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	1 year
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	1 year
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	1 year
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	1 year
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.	1 year
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	1 year
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	1 year
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	1 year
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	5 year
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	5 year

Collaborators and Investigators

• Sponsor: Queen Mary Hospital, Hong Kong
• Investigators: Principal Investigator: Brian SH Ho, MBBS, Queen Mary Hospital, Hong Kong

Publications and helpful links

General 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Helpful Links

• 2016 Hong Kong Population By-census results reveal latest demographic trends [Internet]. Census and Statistics Department

Study record dates

Study Major Dates

• Study Start (Estimated): October 1, 2023
• Primary Completion (Estimated): September 30, 2030
• Study Completion (Estimated): September 30, 2031

Study Registration Dates

• First Submitted: April 26, 2023
• First Submitted That Met QC Criteria: September 7, 2023
• First Posted (Actual): September 14, 2023

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 7, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Urinary retention; BPH; TURP; PUL; prostatic urethral lift
• Additional Relevant MeSH Terms: Urologic Diseases; Urination Disorders; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urinary Retention
• Other Study ID Numbers: QMH PULTUR Study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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