Study on Water Vapor Thermal Therapy

Prospective Observational Study on Water Vapor Thermal Therapy in Management of Patients with Benign Prostatic Hyperplasia (BPH)

The goal of this observational study is to learn about the efficacy of Rezum water vapor thermal therapy in benign prostatic hyperplasia patients. The main question it aims to answer is:

• Is Rezum an effective treatment?
• Is Rezum safe?

Participants will be followed up for at least three months after the treatment to evaluate efficacy and safety.

Study Overview

• Status: Recruiting
• Conditions: Benign Prostatic Hyperplasia
• Intervention / Treatment: Procedure: Rezum (water vapor thermal therapy)

Detailed Description

This prospective cohort study aims to evaluate the safety and efficacy of the Rezum procedure, a minimally invasive treatment for benign prostatic hyperplasia (BPH) that utilizes convective water vapor thermal energy. The Rezum procedure was approved by the U.S. FDA in 2015, and recent approval by South Korea's Ministry of Health and Welfare has allowed its use in South Korean patients. Unlike other BPH treatments, Rezum delivers steam at 103°C directly into the prostatic tissue, inducing necrosis and reduction of prostate size through a controlled thermal effect. This process is conducted in a day-surgery setting under local, general, or spinal anesthesia, minimizing patient burden and recovery time.

The study will enroll male patients aged 50 or older with confirmed BPH who meet specific prostate size criteria, measured via transrectal ultrasound. Following a preoperative evaluation, including prostate size, PSA levels, symptom questionnaires, and urodynamic assessment, patients will undergo the Rezum procedure. This involves cystoscope-guided needle insertion into hypertrophic prostate regions, where targeted thermal energy is delivered in short bursts. The procedure is completed within a single hospital visit, and patients are generally discharged on the same day unless complications arise.

After surgery, participants will have routine follow-up visits, including catheter removal and initial voiding assessments within one week. Further follow-up, at a minimum of three months, will include standardized assessments of voiding function, symptom severity (IPSS, IIEF, OAB-q), prostate size, uroflowmetry, and residual urine volume. The safety profile will be assessed by recording adverse events, including infection, hematuria, voiding dysfunction, and the necessity for catheter reinsertion. Complications will be classified according to the Clavien-Dindo classification system.

Data analysis will assess the preoperative and postoperative changes in symptom severity, functional parameters, and prostate measurements. Comparisons of these continuous variables will utilize paired sample t-tests or Wilcoxon signed-rank tests, depending on normality test results. Variables include IPSS, IIEF, OAB-q, prostate size, PSA, maximum flow rate (Qmax), and post-void residual volume (PVR). Additionally, multiple regression analysis will identify factors contributing to the need for postoperative catheter reinsertion. Statistical significance will be set at α=0.05, with p-values below 0.05 indicating significant differences.

This study will address a current gap in research on the Rezum procedure's impact on Korean patients, contributing to the understanding of this minimally invasive approach within different populations and expanding its potential applicability.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Hee Youn Kim, M.D., Ph.D.; Phone Number: 82-10-9024-6533; Email: khyoun10589@gmail.com
• Study Contact Backup: Name: Seung-Ju Lee, M.D., Ph.D.; Phone Number: 82-10-5910-7278; Email: seungju@catholic.ac.kr

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
      • Recruiting
      • Saint Vincent's Hospital
      • Contact: Hee Youn Kim, M.D., Ph.D.; Phone Number: 82-10-9024-6533; Email: khyoun10589@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study subjects are patients requiring surgery for benign prostatic hyperplasia (BPH).

Description

Inclusion Criteria:

• Age 50 or older
• Prostate size between 30cc and 80cc as measured by transrectal ultrasound
• Patients scheduled for Rezum surgery for BPH

Exclusion Criteria:

• Suspected prostate cancer
• Suspected urinary tract infection
• Inability to complete follow-up
• Patients who do not consent to participate in the study

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Rezum Group; Patients who underwent Rezum water vapor thermal therapy treatment for BPH	Procedure: Rezum (water vapor thermal therapy); Rezum or water vapor thermal therapy is a procedure that involves injecting steam at 103°C into the prostate tissue to induce necrosis and reduce the size of the enlarged prostate.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qmax	Maximal urine flow rate in uroflowmetry exam	From enrollment to three months after treatment
International Prostate Symptom Score (IPSS)	International Prostate Symptom Score (IPSS) is a validated, reproducible scoring system to assess disease severity and response to therapy for BPH. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.	From enrollment to three months after treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Complications evaluated using the Clavien-Dindo classification	Three months after treatment

Collaborators and Investigators

• Sponsor: Saint Vincent's Hospital, Korea
• Investigators: Principal Investigator: Hee Youn Kim, M.D., Ph.D., St Vincent's Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028

Study Registration Dates

• First Submitted: October 22, 2024
• First Submitted That Met QC Criteria: October 22, 2024
• First Posted (Actual): October 24, 2024

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: November 4, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Benign Prostatic Hyperplasia; Rezum; Water Vapor Thermal Therapy
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia; Hyperplasia
• Other Study ID Numbers: SVHWVTT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD will be shared upon reasonable request to the PI. The investigators do not have a specific URL to provide the information.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No