BETTY: BEnign Prostatic Hyperplasia Transperineal Targeted Microwave therapY

NCT05443451 | Recruiting

• 1 other identifier: CRE 2022.249
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study on applying 3D-Ultrasound-Guided Transperineal Microwave needle ablation for men with symptomatic benign prostatic hyperplasia (BPH).

Conditions

Prostate Hyperplasia

Outcome Measures

Primary Outcomes (1)

• Adverse events (AE) and serious adverse events (SAE) related to the treatment

  The severity of AE is grade by Clavien-Dindo classification.

  At 1 month

Secondary Outcomes (13)

• Prostate volume change

  Baseline, 3 months, 6 months

• Urinary symptoms measured by International Prostate Symptom Score (IPSS) score

  Baseline, 1 month, 3 months, 6 months

• Erectile function measured by International Index of Erectile Function 5-item version (IIEF-5) score

  Baseline, 1 month, 3 months, 6 months

• Ejaculatory function measured by MSHQ-EjD-SF (function and bother) score

  Baseline, 1 month, 3 months, 6 months

• Change in urodynamic in uroflowmetry

  Baseline, 1 month, 3 months, 6 months

Study Arms (1)

Transperineal Microwave needle ablation for symptomatic BPH

EXPERIMENTAL

Device: 3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH

Interventions

3D-Ultrasound-Guided Transperineal Microwave needle ablation of BPH DEVICE

The procedure will consist of a focal, transperineal, targeted microwave ablation of prostate adenoma. Surgical planning using 3D transrectal ultrasound and real-time monitoring of the ablation would preserve key anatomical landmarks such as the bladder neck, prostatic urethra and verumontanum. The Organ-Based Tracking (OBT®) patented technology would provide a 3D prostate model to facilitate real-time navigation-guided ablation and accurate mapping of treatment zone. The procedure will be conducted under general anaesthesia, spinal anaesthesia, or monitored anaesthetic care / sedation. An average number of one to three microwave ablations per lobe is expected, depending on the size and shape of each prostate. The microwave ablation parameters will be chosen intraoperatively. A urinary catheter may be necessary immediately after the procedure. Patients are planned to be discharged on the same day or the day after when they are fit for discharge.

Transperineal Microwave needle ablation for symptomatic BPH

Eligibility Criteria

• Age: 50 Years+
• Gender Eligibility Details: Male with prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 50 years.
• Benign prostatic hyperplasia with prostate size 30-80 cc
• IPSS ≥ 14
• PSA ≤ 4 ng/mL or PSA \>4 ng/mL with no evidence of suspicious lesion on mpMRI
• Maximum urine flow rate (Qmax) ≤ 15 mL/s.
• Post-Void Residual ≤ 150 mL.
• Patient suitable for IV sedation and/or spinal anaesthesia and/or general anaesthesia and focal microwave ablation.
• Informed written consent

You may not qualify if:

• Significant intravesical median lobe hyperplasia.
• Suspicious lesion on mpMRI prostate
• History of prostate, bladder or urethral surgery.
• History of prostate cancer
• Presence of stones, bladder diverticulum and/or bladder tumor
• History of long-term indwelling catheter.
• Urethral stricture
• Known coagulopathy or on anticoagulant
• Presence of a pacemaker.
• Active infection
• Dysuria due to bladder dysfunction.
• Serious medical illness, including any of the following: uncontrolled congestive heart failure, uncontrolled angina, myocardial infarction, cerebrovascular event within 6 months prior to the screening visit.
• Neurological disorders that would impact bladder function (e.g., multiple sclerosis, Parkinson's disease, spinal cord injury).
• Contraindications for mpMRI exam or MR contrast
• Acute and/or chronic renal failure (GFR \<50 ml/min and serum creatinine \> 1.5 mg/d).

Sponsors & Collaborators

• Chinese University of Hong Kong: lead
• Koelis: collaborator

Study Sites (1)

Prince of Wales Hospital

Hong Kong, Hong Kong

RECRUITING

Related Publications (12)

• Zhang W, Zhang X, Li H, Wu F, Wang H, Zhao M, Hu H, Xu K. Prevalence of lower urinary tract symptoms suggestive of benign prostatic hyperplasia (LUTS/BPH) in China: results from the China Health and Retirement Longitudinal Study. BMJ Open. 2019 Jun 19;9(6):e022792. doi: 10.1136/bmjopen-2018-022792.

  PMID: 31221864 BACKGROUND

• Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Nandy I, Morrill BB, Gagnier RP, Montorsi F; CombAT Study Group. The effects of combination therapy with dutasteride and tamsulosin on clinical outcomes in men with symptomatic benign prostatic hyperplasia: 4-year results from the CombAT study. Eur Urol. 2010 Jan;57(1):123-31. doi: 10.1016/j.eururo.2009.09.035. Epub 2009 Sep 19.

  PMID: 19825505 BACKGROUND

• Ng CF, Yee CH, Chan CK, Wong HM, Chiu PK, Tsu JH, Teoh JY, Ho KL. Bipolar transurethral vapourisation versus monopolar transurethral resection of prostate: a randomised controlled trial. Hong Kong Med J. 2017 Jun;23 Suppl 2(3):32-34. No abstract available.

  PMID: 29938669 BACKGROUND

• Yee CH, Wong JH, Chiu PK, Chan CK, Lee WM, Tsu JH, Teoh JY, Ng CF. Short-stay transurethral prostate surgery: A randomized controlled trial comparing transurethral resection in saline bipolar transurethral vaporization of the prostate with monopolar transurethral resection. Asian J Endosc Surg. 2015 Aug;8(3):316-22. doi: 10.1111/ases.12197. Epub 2015 Jun 3.

  PMID: 26042336 BACKGROUND

• Madersbacher S, Lackner J, Brossner C, Rohlich M, Stancik I, Willinger M, Schatzl G; Prostate Study Group of the Austrian Society of Urology. Reoperation, myocardial infarction and mortality after transurethral and open prostatectomy: a nation-wide, long-term analysis of 23,123 cases. Eur Urol. 2005 Apr;47(4):499-504. doi: 10.1016/j.eururo.2004.12.010. Epub 2005 Jan 23.

  PMID: 15774249 BACKGROUND

• Raizenne BL, Zheng X, Mao J, Zorn KC, Cho A, Elterman D, Bhojani N, Sedrakyan A, Chughtai B. Real-world data comparing minimally invasive surgeries for benign prostatic hyperplasia. World J Urol. 2022 May;40(5):1185-1193. doi: 10.1007/s00345-021-03926-9. Epub 2022 Feb 2.

  PMID: 35107632 BACKGROUND

• Chughtai B, Elterman D, Shore N, Gittleman M, Motola J, Pike S, Hermann C, Terrens W, Kohan A, Gonzalez RR, Katz A, Schiff J, Goldfischer E, Grunberger I, Tu LM, Alshak MN, Kaminetzky J. The iTind Temporarily Implanted Nitinol Device for the Treatment of Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia: A Multicenter, Randomized, Controlled Trial. Urology. 2021 Jul;153:270-276. doi: 10.1016/j.urology.2020.12.022. Epub 2020 Dec 26.

  PMID: 33373708 BACKGROUND

• McVary KT, Gittelman MC, Goldberg KA, Patel K, Shore ND, Levin RM, Pliskin M, Beahrs JR, Prall D, Kaminetsky J, Cowan BE, Cantrill CH, Mynderse LA, Ulchaker JC, Tadros NN, Gange SN, Roehrborn CG. Final 5-Year Outcomes of the Multicenter Randomized Sham-Controlled Trial of a Water Vapor Thermal Therapy for Treatment of Moderate to Severe Lower Urinary Tract Symptoms Secondary to Benign Prostatic Hyperplasia. J Urol. 2021 Sep;206(3):715-724. doi: 10.1097/JU.0000000000001778. Epub 2021 Apr 19.

  PMID: 33872051 BACKGROUND

• Chiu PK, Lo KL, Teoh JY, Ma SF, Leung CH, Wong HF, Li KM, Sae-Lo K, Kwok SW, Li SY, Yee CH, Hou SM, Ng CF. Sectoral cancer detection and tolerability of freehand transperineal prostate biopsy under local anaesthesia. Prostate Cancer Prostatic Dis. 2021 Jun;24(2):431-438. doi: 10.1038/s41391-020-00293-1. Epub 2020 Sep 30.

  PMID: 32999465 BACKGROUND

• Barry Delongchamps N, Schull A, Anract J, Abecassis JP, Zerbib M, Sibony M, Jilet L, Abdoul H, Goffin V, Peyromaure M. Feasibility and safety of targeted focal microwave ablation of the index tumor in patients with low to intermediate risk prostate cancer: Results of the FOSTINE trial. PLoS One. 2021 Jul 14;16(7):e0252040. doi: 10.1371/journal.pone.0252040. eCollection 2021.

  PMID: 34260598 BACKGROUND

• Lo KL, Chui KL, Leung CH, Ma SF, Lim K, Ng T, Wong J, Li JKM, Mak SK, Ng CF. Outcomes of transperineal and transrectal ultrasound-guided prostate biopsy. Hong Kong Med J. 2019 Jun;25(3):209-215. doi: 10.12809/hkmj187599. Epub 2019 May 29.

  PMID: 31178436 BACKGROUND

• Dindo D, Demartines N, Clavien PA. Classification of surgical complications: a new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg. 2004 Aug;240(2):205-13. doi: 10.1097/01.sla.0000133083.54934.ae.

  PMID: 15273542 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Peter Ka-Fung CHIU, FRCS, PhD

  Chinese University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Ka-Fung CHIU, FRCS, PhD

CONTACT

3505-2625; peterchiu@surgery.cuhk.eud.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 5, 2022
• Study Start: September 8, 2022
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: May 6, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)