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ClinicalTrials.gov ID

NCT07663344

Lead Sponsor

Chinese University of Hong KongOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

15Estimated

Last Update Posted

Jun 23, 2026Actual

Start Date

Jun 1, 2026Estimated

Primary Completion Date

Dec 31, 2027Estimated

Completion Date

Mar 31, 2028Estimated

Official Title

Prospective Feasibility Trial on MRI-TRUS Fusion Water Vapour Ablation for Benign Prostatic Hyperplasia (STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning)

Brief Summary

The STEAM-MAP 1 Study is a single-arm, prospective feasibility trial evaluating the integration of MRI-transrectal ultrasound (TRUS) fusion guidance into Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH).

Detailed Description

This study aims to assess the feasibility, procedural characteristics, and early safety of MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor therapy in men with symptomatic benign prostatic hyperplasia.

Eligible patients with prior MRI prostate fulfilling the eligibility criteria will be enrolled from the participating hospitals. Baseline assessment including symptom severity and uroflowmetric measurements, urine culture will be performed in the usual routine pre-Rezūm nurse-led clinics. The intervention will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics. .

• Benign Prostatic Hyperplasia (BPH)

• MRI-TRUS fusion-guided Rezūm therapy

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

Male

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• Age 30-80 years old with symptomatic BPH.
• Prostate volume 30-80 mL (TRUS/MRI/US)
• Suitable for Rezum.
• Able to consent and comply with follow-up to 1 month.
• With prior prostate MRI within 2 years

Exclusion Criteria:

• Known/suspected prostate cancer requiring oncologic management.
• Prior prostate surgery impacting urethral anatomy within 12 months.
• Prior implant affecting urethral anatomy.
• Active UTI or untreated bacteriuria pre-op.
• Uncorrectable coagulopathy; inability to manage antithrombotics.
• Severe medical comorbidity precluding endoscopy.

Primary Purpose

Treatment

Allocation

N/A

Interventional Model

Single Group Assignment

Masking

None (Open Label)

Lead Sponsor

Chinese University of Hong KongOTHER

steffiyuen@surgery.cuhk.edu.hk35052625

lokalun@surgery.cuhk.edu.hk35052625