Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Rezum.
- Who it may be relevant to
- Registry conditions: Benign Prostatic Hyperplasia. Basic parameters: 45 years — 85 years · Male.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Device 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 t
Primary outcome measures
- International Prostate Symptom Score (IPSS) change from baseline to 3 months. [Time frame: 3 months]
Secondary outcome measures (6)
- International Prostate Symptom Score (IPSS) change from baseline to 1 month, 3 months, 6 months, 1 year, then annually to 3 years. [Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years]
- The change of peak flow rate (Qmax) [Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years]
- Post void residual urine volume (PVR） [Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years]
- Quality of life (QoL) questionnaire [Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years]
- Ejective function (MSHQ-EjD) [Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years]
- The change of International Index of Erectile Function (IIEF) [Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years]
Eligibility criteria
Inclusion criteria
- 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 > 30 ml.
- Subject able to complete the study protocol in the opinion of the Principal Investigator.
Exclusion criteria
- 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.
- Bleeding disorder (note that use of anti-platelet medication is not an exclusion criterion).
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06607094 · IUNU-SR-103