Transurethral Thermodilatation vs. Prostatic Urethral Lift for Moderate-to-Severe BPH

NCT07759752 | Not Yet Recruiting FDA Device

• 1 other identifier: UW 26-303
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial aims to determine whether Prolieve® (microwave with balloon dilation) is as effective as UroLift® (prostate implants) for treating moderate-to-severe lower urinary tract symptoms in men aged 50-80 with enlarged prostates (BPH) who have failed oral medications. The main questions are:

1. 1.Is Prolieve non-inferior to UroLift in improving IPSS symptom scores at 3 months?
2. 2.Does Prolieve cause less pain and avoid the need for injected anaesthesia?

Conditions

BPH (Benign Prostatic Hyperplasia); LUTS(Lower Urinary Tract Symptoms)

Keywords

Transurethral Thermodilatation; Prostatic Urethral Lift; BPH; LUTS

Outcome Measures

Primary Outcomes (1)

• Change in International Prostate Symptom Score (IPSS) at 3 Months

  Mean change in total IPSS score from baseline to 3 months post-procedure. IPSS ranges from 0-35 (higher = worse symptoms); negative change indicates improvement. Non-inferiority margin is 3 points. Analysis uses ANCOVA with treatment arm as fixed effect, adjusted for baseline IPSS, prostate volume stratum (\<40 vs ≥40 g), and baseline IPSS severity stratum (moderate 13-19 vs severe ≥20).

  Baseline to 3 months post-procedure

Secondary Outcomes (12)

• Change in IPSS total score at 6 months

  Baseline to 6 months post-procedure

• Change in IPSS Quality of Life Bother Score

  Baseline to 3, 6, and 12 months post-procedure

• Change in peak urinary flow rate (Qmax)

  Baseline to 3, 6, and 12 months post-procedure

• Change in post-void residual volume (PVR)

  Baseline to 3, 6, and 12 months post-procedure

• Change in erectile function (IIEF-5)

  Baseline to 3, 6, and 12 months post-procedure

Other Outcomes (1)

• Cost per responder at 3 months

  3 months post-procedure

Study Arms (2)

Prolieve Transurethral Thermodilatation

EXPERIMENTAL

Prolieve TUTD involves inserting a treatment catheter under intraurethral lidocaine gel only (no injected anaesthetic or sedation). A 46 French balloon dilates the prostatic urethra while microwave energy (≤50 W) heats periurethral tissue to 41-46°C for 45 minutes, combining mechanical dilatation with thermal ablation. Catheter removed immediately post-procedure; same-day discharge.

Device: Prolieve Transurethral Thermodilatation System

UroLift Prostatic Urethral Lift

ACTIVE COMPARATOR

UroLift PUL involves cystoscopic deployment of 4-6 permanent nitinol anchors to retract obstructing lateral prostatic lobes, mechanically widening the urethra without tissue ablation. Performed with topical intraurethral lidocaine gel, with or without periprostatic nerve block per site practice. No routine post-procedural catheterisation; same-day discharge.

Device: UroLift Prostatic Urethral Lift System

Interventions

Prolieve Transurethral Thermodilatation System DEVICE

Prolieve is a minimally invasive, FDA-approved thermotherapy device for BPH. It delivers simultaneous microwave energy (≤50 W) and 46 French balloon dilatation to the prostatic urethra for 45 minutes. It is performed under intraurethral lidocaine gel only-no injected anaesthesia, no sedation, and no operating theatre. Catheter is removed immediately post-procedure; same-day discharge.

Also known as: Prolieve TUTD, Prolieve System

Prolieve Transurethral Thermodilatation

UroLift Prostatic Urethral Lift System DEVICE

UroLift is a minimally invasive, FDA-cleared device for BPH. It deploys 4-6 permanent nitinol implants under cystoscopic guidance to mechanically retract and hold open the obstructing prostatic lobes, widening the urethra without tissue ablation. Performed with topical intraurethral lidocaine gel, with or without periprostatic nerve block per site practice. No routine post-procedural catheterisation; same-day discharge.

Also known as: UroLift PUL, UroLift System

UroLift Prostatic Urethral Lift

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants must satisfy ALL of the following:
• Male, aged ≥ 50 and ≤ 80 years
• Moderate-to-severe LUTS due to BPH: IPSS total score ≥ 13 at screening
• Peak urinary flow rate (Qmax) ≥ 5 and ≤ 12 mL/s with minimum voided volume ≥ 125 mL on free uroflowmetry. The lower Qmax bound of ≥ 5 mL/s excludes near-complete retention with likely detrusor underactivity, as adopted in the Rezūm pivotal trial
• Prostate volume 30-80 g by transrectal ultrasound (TRUS) or multiparametric MRI, consistent with the L.I.F.T. and Rezūm pivotal study ranges
• Post-void residual (PVR) ≤ 250 mL by bladder ultrasound
• Currently on, or has previously tried, medical therapy for BPH (alpha-blocker and/or 5-alpha-reductase inhibitor) for ≥ 4 weeks with inadequate symptom control, or documented intolerance to medical therapy
• Able to provide written informed consent
• Able and willing to attend all study follow-up visits

You may not qualify if:

• Participants will be excluded if ANY of the following apply:
• Intravesical prostatic protrusion \> 10 mm on TRUS.
• Presence of metallic pelvic implants, penile prosthesis, femoral metallic implant, cardiac pacemaker, or implantable cardioverter-defibrillator.
• Previous transurethral resection of the prostate (TURP), HoLEP, or any prior endoscopic prostate surgery.
• Prior pelvic radiation therapy.
• Prostatic urethral length \< 1.2 cm or \> 5.5 cm.
• Confirmed or suspected prostate carcinoma (unresolved elevated PSA without negative biopsy, or any known malignancy).
• Active urinary tract infection at screening.
• Bladder stone, bladder tumour, or suspected bladder malignancy.
• Urethral stricture or bladder neck contracture precluding catheter passage (Foley ≥ 18 Fr).
• Neurogenic bladder or known clinically significant detrusor underactivity.
• History of acute urinary retention.
• Coagulopathy or therapeutic anticoagulation that cannot be bridged perioperatively.
• Renal impairment: eGFR \< 30 mL/min/1.73 m² (Cockcroft-Gault).
• Desire to preserve fertility (due to risk of retrograde ejaculation with either device).

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

Queen Mary Hospital

Hong Kong, Hong Kong

Location

Related Publications (21)

• Barry MJ, Fowler FJ Jr, O'leary MP, Bruskewitz RC, Holtgrewe HL, Mebust WK, Cockett AT; Measurement Committee of the American Urological Association. The American Urological Association Symptom Index for Benign Prostatic Hyperplasia. J Urol. 2017 Feb;197(2S):S189-S197. doi: 10.1016/j.juro.2016.10.071. Epub 2016 Dec 22.

  PMID: 28012747 BACKGROUND

• Olweny EO, Jow SL, Jow WW. Prolieve Transurethral Thermodilatation for Treatment of Symptomatic Benign Prostatic Hyperplasia: 5-Year Results from a Prospective Multicenter Trial. J Endourol. 2022 Jan;36(1):117-123. doi: 10.1089/end.2021.0240. Epub 2021 Nov 1.

  PMID: 34314241 BACKGROUND

• 21. Lerner LB, et al. AUA Guideline Amendment 2023 - TUMT background evidence. J Urol. 2024

  BACKGROUND

• McVary KT, Rogers T, Roehrborn CG. Rezum Water Vapor Thermal Therapy for Lower Urinary Tract Symptoms Associated With Benign Prostatic Hyperplasia: 4-Year Results From Randomized Controlled Study. Urology. 2019 Apr;126:171-179. doi: 10.1016/j.urology.2018.12.041. Epub 2019 Jan 21.

  PMID: 30677455 BACKGROUND

• Wiemer L, Lehmacher W, Schonburg S, Gratzke C, Miller K, Patrick Papp C. Defining the Minimal Important Difference in International Prostate Symptom Score for Men with Lower Urinary Tract Symptoms Using a Patient-centered Anchor Measure. Eur Urol Open Sci. 2025 Sep 25;81:44-49. doi: 10.1016/j.euros.2025.09.003. eCollection 2025 Nov.

  PMID: 41079976 BACKGROUND

• Kristensen-Alvarez A, Fode M, Stroomberg HV, Nielsen KK, Arch A, Lonn LB, Taudorf M, Widecrantz SJ, Roder A. Non-inferiority, randomised, open-label clinical trial on the effectiveness of transurethral microwave thermotherapy compared to prostatic artery embolisation in reducing severe lower urinary tract symptoms in men with benign prostatic hyperplasia: study protocol for the TUMT-PAE-1 trial. Trials. 2024 Sep 2;25(1):574. doi: 10.1186/s13063-024-08409-x.

  PMID: 39223593 BACKGROUND

• Barry MJ, et al. Measurement of minimal important differences in the International Prostate Symptom Score. Urology. 1995.

  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

• Roehrborn CG, Gange SN, Shore ND, Giddens JL, Bolton DM, Cowan BE, Brown BT, McVary KT, Te AE, Gholami SS, Rashid P, Moseley WG, Chin PT, Dowling WT, Freedman SJ, Incze PF, Coffield KS, Borges FD, Rukstalis DB. The prostatic urethral lift for the treatment of lower urinary tract symptoms associated with prostate enlargement due to benign prostatic hyperplasia: the L.I.F.T. Study. J Urol. 2013 Dec;190(6):2161-7. doi: 10.1016/j.juro.2013.05.116. Epub 2013 Jun 11.

  PMID: 23764081 BACKGROUND

• Franco JV, Garegnani L, Escobar Liquitay CM, Borofsky M, Dahm P. Transurethral microwave thermotherapy for the treatment of lower urinary tract symptoms in men with benign prostatic hyperplasia. Cochrane Database Syst Rev. 2021 Jun 28;6(6):CD004135. doi: 10.1002/14651858.CD004135.pub4.

  PMID: 34180047 BACKGROUND

• Dixon C, et al. Randomized, double-blind, sham-controlled study evaluating the safety and efficacy of prostatic tissue ablation with the Rezūm system. Can J Urol. 2015.

  BACKGROUND

• Dixon C, Cedano ER, Pacik D, Vit V, Varga G, Wagrell L, Tornblom M, Mynderse L, Larson T. Efficacy and Safety of Rezum System Water Vapor Treatment for Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. Urology. 2015 Nov;86(5):1042-7. doi: 10.1016/j.urology.2015.05.046. Epub 2015 Jul 26.

  PMID: 26216644 BACKGROUND

• Dupitout L, Bladou F, Bernhard JC, Capon G, Alezra E, Simeon H, Michiels C, Allenet C, Deslandes M, Marquette T, Robert G. [Prostatic Urethral Lift under local anesthesia: Single-centre retrospective observational study]. Prog Urol. 2022 Mar;32(3):182-188. doi: 10.1016/j.purol.2021.09.003. Epub 2021 Oct 6. French.

  PMID: 34627668 BACKGROUND

• Moretto S, Wirtzfeld N, Doizi S. Local anesthesia for UroLift(R): a systematic review of the literature. World J Urol. 2025 Jul 15;43(1):435. doi: 10.1007/s00345-025-05795-y.

  PMID: 40663180 BACKGROUND

• 6. Prolieve® System User Manual and Instructions for Use. Medifocus Inc. Part No. 90399939-02 Rev. D.

  BACKGROUND

• 5. EAU Guidelines on Management of Non-neurogenic Male LUTS. European Association of Urology. 2026.

  BACKGROUND

• Sandhu JS, Bixler BR, Dahm P, Goueli R, Kirkby E, Stoffel JT, Wilt TJ. Management of Lower Urinary Tract Symptoms Attributed to Benign Prostatic Hyperplasia (BPH): AUA Guideline Amendment 2023. J Urol. 2024 Jan;211(1):11-19. doi: 10.1097/JU.0000000000003698. Epub 2023 Sep 14.

  PMID: 37706750 BACKGROUND

• 3. Hong Kong Centre for Health Protection. Men's Health Line - Benign Prostatic Hyperplasia. https://www.chp.gov.hk/en/static/80028.html

  BACKGROUND

• Emberton M, Andriole GL, de la Rosette J, Djavan B, Hoefner K, Vela Navarrete R, Nordling J, Roehrborn C, Schulman C, Teillac P, Tubaro A, Nickel JC. Benign prostatic hyperplasia: a progressive disease of aging men. Urology. 2003 Feb;61(2):267-73. doi: 10.1016/s0090-4295(02)02371-3. No abstract available.

  PMID: 12597928 BACKGROUND

• Macey MR, Raynor MC. Medical and Surgical Treatment Modalities for Lower Urinary Tract Symptoms in the Male Patient Secondary to Benign Prostatic Hyperplasia: A Review. Semin Intervent Radiol. 2016 Sep;33(3):217-23. doi: 10.1055/s-0036-1586142.

  PMID: 27582609 BACKGROUND

• Blanker MH, Alma HJ, Devji TS, Roelofs M, Steffens MG, van der Worp H. Determining the minimal important differences in the International Prostate Symptom Score and Overactive Bladder Questionnaire: results from an observational cohort study in Dutch primary care. BMJ Open. 2019 Dec 23;9(12):e032795. doi: 10.1136/bmjopen-2019-032795.

  PMID: 31874883 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM

  The University of Hong Kong, Hospital Authority

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shung Lai John Leung, MBBS, FRCSEd, FCSHK, FHKAM

CONTACT

+852 2255 4310; jslleung@hku.hk

Yusra Saleem, BSc

CONTACT

yusra@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: Clinical Assistant Professor

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 12, 2026
• Study Start: August 6, 2026
• Primary Completion (Estimated): August 5, 2029
• Study Completion (Estimated): November 5, 2029
• Last Updated: August 12, 2026

Record last verified: 2026-08

Locations

HK (1)