Study on Water Vapor Thermal Therapy

NCT06656689 | Recruiting DMC

• 1 other identifier: SVHWVTT
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Benign Prostatic Hyperplasia

Keywords

Benign Prostatic Hyperplasia; Rezum; Water Vapor Thermal Therapy

Outcome Measures

Primary Outcomes (2)

• 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

• Qmax

  Maximal urine flow rate in uroflowmetry exam

  From enrollment to three months after treatment

Secondary Outcomes (1)

• Complications

  Three months after treatment

Study Arms (1)

Rezum Group

Patients who underwent Rezum water vapor thermal therapy treatment for BPH

Procedure: Rezum (water vapor thermal therapy)

Interventions

Rezum (water vapor thermal therapy) PROCEDURE

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.

Rezum Group

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Saint Vincent's Hospital, Korea: lead

Study Sites (1)

Saint Vincent's Hospital

Suwon, Gyeonggi-do, 16247, South Korea

RECRUITING

Related Publications (1)

• 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.

  PMID: 33872051 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Hee Youn Kim, M.D., Ph.D.

  St Vincent's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hee Youn Kim, M.D., Ph.D.

CONTACT

82-10-9024-6533; khyoun10589@gmail.com

Seung-Ju Lee, M.D., Ph.D.

CONTACT

82-10-5910-7278; seungju@catholic.ac.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 24, 2024
• Study Start: July 31, 2023
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): October 31, 2028
• Last Updated: November 6, 2024

Record last verified: 2024-11

Locations

KR (1)