Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia

NCT ID: NCT06607094

Last Updated: 2024-09-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-30
• Study Completion Date: 2027-09-30

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.

Detailed Description

For BPH, open or transurethral anatomical enucleation is recommended. Open prostatectomy has a higher risk of bleeding and slower postoperative recovery, with a higher probability of requiring blood transfusion. The incidence of urinary incontinence after transurethral enucleation ranges from 3.33% to 20%, possibly due to excessive traction and compression on the external urethral sphincter, leading to partial muscle fiber rupture. The rate of erectile dysfunction after enucleation is 8.82%, while retrograde ejaculation occurs in 6.37% of cases, especially for patients with larger prostates. Once these complications occur, they are often difficult to recover from and severely impact the patient's quality of life. In our center, the technique of Rezum has been further improved by incorporating ultrasound and MRI imaging guidance. The investigators design a reasonable and comprehensive ablation plan that ensures accurate positioning of enlarged prostate glands for complete and thorough ablation while ensuring efficacy and safety. The optimized methods mainly include ablation optimization and combined imaging techniques.

Conditions

Benign Prostatic Hyperplasia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Optimized Water Vapor Thermal Therapy

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

Group Type: EXPERIMENTAL

Rezum

Intervention Type: 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.

Interventions

Rezum

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. Male subjects ≥ 45 years of age who have obstructive symptoms secondary to BPH requiring invasive intervention.

2. IPSS score of ≥ 13.

3. Qmax: Peak flow rate ≤ 15 ml/sec.

4. Post-void residual (PVR) < 300 ml.

5. Prostate volume > 30 ml.

6. Subject able to complete the study protocol in the opinion of the Principal Investigator.

Exclusion Criteria

1. History of any illness or surgery that in the opinion of the Principal Investigator may confound the results of the study.

2. Any prior minimally invasive intervention or surgical intervention for the symptoms of BPH.

3. Currently enrolled in another clinical trial.

4. Confirmed or suspected malignancy of prostate or bladder.

5. Documented active urinary tract infection by culture or bacterial prostatitis.

6. Neurogenic bladder or sphincter abnormalities.

7. Urethral strictures, bladder neck contracture or muscle spasms.

8. Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).

9. Subjects who are interested in maintaining fertility.

10. Significant urge incontinence.

11. Unable or unwilling to sign the Informed Consent Form.

12. Any cognitive disorder that interferes with or precludes a subject from directly and accurately communicating with the Principal Investigator regarding the study.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Qun Lu, PhD

Role: CONTACT

luqun_1989@126.com

8615195856020

Qun Lu

Role: CONTACT

luqun_1989@126.com

8615195856020

Other Identifiers

IUNU-SR-103

Identifier Type: -

Identifier Source: org_study_id