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NCT Number: NCT06607094

Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia

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.

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Key information

Conditions

Benign Prostatic Hyperplasia Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

45 year–85 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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.

Secondary outcomes

  1. 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

    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 1 month, 3 months, 6 months, 1 year, then annually to 3 years. The mean change in IPSS was calculated.

  2. The change of peak flow rate (Qmax)

    Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years

  3. Post void residual urine volume (PVR）

    Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years

  4. Quality of life (QoL) questionnaire

    Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years

    There is only 1 question about Quality of life due to urinary symptoms which is 'If you were to spend the rest of your life with your urinary condition the way it is now, how would you feel about that?' This question have 0-6 scores according to patient's satisfaction about Quality of Life, the higher score mean patient have poor satisfaction.

    The change was the baseline value minus the value at 1 month, 3 months, 6 months, 1 year, then annually to 3 years.

  5. Ejective function (MSHQ-EjD)

    Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years

    Ejective function (MSHQ-EjD) is a questionnaire used to assess the ejective function. There are 4 questions relating to Ejaculation dysfunction which need patients to answer. 3 questions about patients' ejective function assessing include completion of ejaculation, Strength of ejaculation and Volume of semen when ejaculation. Every question have 0-5 scores according to assessing the ejective function, the lower score mean patient have more severe the ejective function.

    MSHQ-EjD total score: the minimum score is 0 and maximum score are 15. The change are the value at 1 month, 3 months, 6 months, 1 year, then annually to 3 years minus value at baseline.

  6. The change of International Index of Erectile Function (IIEF)

    Time frame: 1 month, 3 months, 6 months, 1 year, then annually to 3 years

    Erectile Function(IIEF) is a questionnaire used to assess the Sexual Health Inventory of men. There are 5 questions relating to Erectile Function which need patients to answer. Every question have 0-5 scores, the lower score mean patient have more severe the Erectile Function.

    The IIEF-5 is administered as a screening instrument for the presence & severity of ED in conjunction with the clinical assessment. The score is the sun of the responses to the five items, so that overall score may range from 0 to 25. A score of 20 or higher indicates a normal degree of erectile functioning. Low scores (10 or less) indicate moderate to severe ED.

    The change are the value at 1 month, 3 months, 6 months, 1 year, then annually to 3 years minus value at baseline.

Study contacts

Contact information is provided by the study sponsor or research team.

Qun Lu

CONTACT

[email protected]

8615195856020

Qun Lu, PhD

CONTACT

[email protected]

8615195856020

Sponsors and collaborators

Lead sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2027
First posted
Sep 23, 2024
Registry last updated
Sep 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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