Modified Water Vapor Thermal Therapy in Management of Patients With Large-volume Benign Prostatic Hyperplasia

NCT06596590 | Not Yet Recruiting FDA Device

• 1 other identifier: IUNU-SR-102
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Water vapor thermal therapy (Rezum) is a minimally invasive treatment for benign prostatic hyperplasia (BPH) that uses injections of sterile water vapor directly into the prostate for tissue ablation. Although Rezum is currently indicated for use in men with prostate sizes ≥30 and ≤80 ml, the guidelines offer no recommendation with regards to Rezum therapy for those with large-volume glands.

Conditions

Benign Prostatic Hyperplasia

Outcome Measures

Primary Outcomes (1)

• International Prostate Symptom Score (IPSS) change from baseline to 3 months.

  International prostate symptom score (IPSS) is a questionnaire used to indicate the severity of LUTS symptoms, There are 7 questions relating to different symptoms subjects be experiencing. 7 questions about patients' urinating include Incomplete emptying, Frequency, Intermittency, Urgency, Weak stream, Straining and Nocturia, every question have 0-5 scores according to Prostate Symptom, the higher score mean patient have more severe the symptoms. IPSS total score: the minimum score is 0 and maximum score are 35. IPSS total 0-7 scores are mild symptoms, IPSS total 8-19 scores are moderate symptoms and IPSS total 20-35 scores are severe symptoms. International Prostate Symptom Score (IPSS) scores were recorded at baseline to 3 months. The mean change in IPSS was calculated.

  from baseline to 3 months

Secondary Outcomes (6)

• International Prostate Symptom Score (IPSS) change from baseline to 1 month, 3 months, 6 months, 1 year, then annually to 3 years.

  1 month, 3 months, 6 months, 1 year, then annually to 3 years

• The change of peak flow rate (Qmax)

  1 month, 3 months, 6 months, 1 year, then annually to 3 years

• Post void residual urine volume (PVR）

  1 month, 3 months, 6 months, 1 year, then annually to 3 years

• Quality of life (QoL)

  1 month, 3 months, 6 months, 1 year, then annually to 3 years

• Ejective function (MSHQ-EjD)

  1 month, 3 months, 6 months, 1 year, then annually to 3 years

Study Arms (1)

Modified Water Vapor Thermal Therapy

EXPERIMENTAL

The Rezum System is designed to treat patients with urinary symptoms associated with large volume BPH.

Device: Rezum

Interventions

Rezum DEVICE

The Rezum System is designed to treat patients with urinary symptoms associated with BPH. The Rezum System utilizes radiofrequency current to generate thermal energy in the form of water vapor, which is then injected into the transition zone and/or median lobe of the prostate in controlled 9-second doses. The vapor injected into the prostate tissue rapidly disperses through the interstitial space between the tissue cells. As the vapor cools, it condenses immediately on contact with tissue, and the stored thermal energy is released, denaturing the cell membranes and causing cell death.

Modified Water Vapor Thermal Therapy

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male subjects ≥ 45 years of age who have obstructive symptoms secondary to BPH requiring invasive intervention.
• IPSS score of ≥ 13.
• Qmax: Peak flow rate ≤ 15 ml/sec.
• Post-void residual (PVR) \< 300 ml.
• Prostate volume between 80 to 120 ml.
• Subject able to complete the study protocol in the opinion of the Principal Investigator.

You may not qualify if:

• History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.
• Any prior minimally invasive intervention or surgical intervention for the symptoms of BPH.
• Currently enrolled in another clinical trial.
• Confirmed or suspected malignancy of prostate or bladder.
• Documented active urinary tract infection by culture or bacterial prostatitis.
• Neurogenic bladder or sphincter abnormalities.
• Urethral strictures, bladder neck contracture or muscle spasms.
• Subjects who are interested in maintaining fertility.
• Significant urge incontinence.
• Unable or unwilling to sign the Informed Consent Form.
• Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

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

Study Officials

• Hongqian Guo, PhD

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  STUDY CHAIR

Central Study Contacts

Hongqian Guo, PhD

CONTACT

8613605171690; dr.ghq@nju.edu.cn

Qun Lu, PhD

CONTACT

861519585602; luqun_1989@126.com

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: Chief physician

Model Details: Modified Water Vapor Thermal Therapy (REZUM) in Management of Patients With Large-volume Benign Prostatic Hyperplasia. The modified methods mainly include ablation optimization and combined imaging techniques.

Study Record Dates

• First Submitted: April 27, 2024
• First Posted: September 19, 2024
• Study Start: September 1, 2024
• Primary Completion: September 1, 2025
• Study Completion (Estimated): September 1, 2027
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

CN (1)