NCT07663344

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).

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Jun 2026

Typical duration for not_applicable

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jun 2026Mar 2028

Study Start

First participant enrolled

June 1, 2026

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

June 18, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 23, 2026

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2028

Last Updated

June 23, 2026

Status Verified

June 1, 2026

Enrollment Period

1.6 years

First QC Date

June 18, 2026

Last Update Submit

June 22, 2026

Conditions

Benign Prostatic Hyperplasia (BPH)

Keywords

Water vapor thermal therapy

Outcome Measures

Primary Outcomes (1)

  • Feasibility: Success rate defined by completion of cases

    Peri-operative period

Secondary Outcomes (11)

  • Duration of operation

    Intra-operation

  • Duration of Software fusion time

    Intra-operation

  • Number of treatment given during the operation

    Intra-operation

  • Rate of discharge on the same day of the operation

    On the day 1 of operation

  • Duration of hospital stay

    Peri-operative period

  • +6 more secondary outcomes

Study Arms (1)

MRI-TRUS fusion water vapour ablation

EXPERIMENTAL

The intervenitons will consist of MRI segmentation and image-informed injection planning, with documentation of planned and delivered injection sites and performance metrics.

Procedure: MRI-TRUS fusion-guided Rezūm therapy

Interventions

MRI-TRUS fusion-guided Rezūm therapyPROCEDURE

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.

MRI-TRUS fusion water vapour ablation

Eligibility Criteria

Age30 Years - 80 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Prince of Wales Hospital

Shatin, 999077, Hong Kong

Location

North District Hospital

Sheung Shui, Hong Kong

Location

Alice Ho Miu Ling Nethersole Hospital

Tai Po, Hong Kong

Location

Related Publications (2)

  • Zhang AY, Xu X. Prevalence, Burden, and Treatment of Lower Urinary Tract Symptoms in Men Aged 50 and Older: A Systematic Review of the Literature. SAGE Open Nurs. 2018 Dec 26;4:2377960818811773. doi: 10.1177/2377960818811773. eCollection 2018 Jan-Dec.

    PMID: 33415211BACKGROUND

  • Liao L, Chuang YC, Liu SP, Lee KS, Yoo TK, Chu R, Sumarsono B, Wang JY. Effect of lower urinary tract symptoms on the quality of life and sexual function of males in China, Taiwan, and South Korea: Subgroup analysis of a cross-sectional, population-based study. Low Urin Tract Symptoms. 2019 Apr;11(2):O78-O84. doi: 10.1111/luts.12220. Epub 2018 Mar 11.

    PMID: 29527813BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic DiseasesGenital Diseases, MaleGenital DiseasesUrogenital DiseasesMale Urogenital Diseases

Central Study Contacts

Qinyang Alex Liu, MBBS, MSc, FRCSEd

CONTACT

852+35052625alexliu@surgery.cuhk.edu.hk

Hong Tim Lau, MSc

CONTACT

852+35053933timlau@surgery.cuhk.edu.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
Assistant Professor

Study Record Dates

First Submitted

June 18, 2026

First Posted

June 23, 2026

Study Start

June 1, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

March 31, 2028

Last Updated

June 23, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Locations

HK(3)