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NCT Number: NCT07663344

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

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).

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

30 year–80 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Prince of Wales Hospital, Shatin, Hong Kong

Loading trial locations.

About this study

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. .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MRI-TRUS fusion-guided Rezūm therapy

Procedure

This study involves MRI-TRUS fusion-guided planning and delivery of Rezūm water vapor thermal therapy for men with symptomatic benign prostatic hyperplasia (BPH). All participants will receive the investigational workflow during their Rezūm procedure. This is a single-arm study with no concurrent control group.

Primary outcomes

  1. Feasibility: Success rate defined by completion of cases

    Time frame: Peri-operative period

Secondary outcomes

  1. Duration of operation

    Time frame: Intra-operation

    The time between scope in and scope out

  2. Duration of Software fusion time

    Time frame: Intra-operation

  3. Number of treatment given during the operation

    Time frame: Intra-operation

  4. Rate of discharge on the same day of the operation

    Time frame: On the day 1 of operation

  5. Duration of hospital stay

    Time frame: Peri-operative period

    Duration of hospital stay in hour since completion of operation

  6. Duration of catheter time in hour since completion of operation

    Time frame: Peri-operative period

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

    Time frame: Month 1

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

  8. Hospital readmission rate since completion of the operation

    Time frame: Month 1

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

    Time frame: Baseline and Month 3

    Change in total scores in International Prostate Symptom Score (ranges from 0 to 35) questionnaires. The higher score, the more worse symptom

  10. Change in voiding function in uroflowmetry

    Time frame: Baseline and Month 3

    It is assessed by maximum flow rate and post void volume in uroflowmetry

  11. Prostate size

    Time frame: Baseline and Month 3

    Assessed by transrectal ultrasound

Study contacts

Contact information is provided by the study sponsor or research team.

Hong Tim Lau, MSc

CONTACT

[email protected]

852+35053933

Qinyang Alex Liu, MBBS, MSc, FRCSEd

CONTACT

[email protected]

852+35052625

Sponsors and collaborators

Lead sponsor

Chinese University of Hong Kong

Other

Registry information

Official study 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)

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Jun 23, 2026
Registry last updated
Jun 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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