STEAM-MAP 1 Study - Steam Therapy With MRI and AI-assisted Planning

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age30-80
SponsorChinese University of Hong Kong

About this trial

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).

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • MRI-TRUS fusion-guided Rezūm therapy

Treatment groups

15 Participants
are divided into 1 treatment group

Locations

3
Prince of Wales Hospital999077, Shatin Hong Kong
North District Hospital Sheung Shui Hong Kong
Alice Ho Miu Ling Nethersole Hospital Tai Po Hong Kong

Sponsors and collaborators

Chinese University of Hong Kong

Lead sponsor