Benign Prostatic HyperplasiaNCT06607094
Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia
A study testing Rezum in people with Benign Prostatic Hyperplasia, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Rezum
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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
- Being tested
- Rezum
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RezumDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Optimized Water Vapor Thermal Therapy | Experimental | The Rezum System is designed to treat patients with urinary symptoms associated with BPH. Receives: Device: Rezum |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: 1 month, 3 months, 6 months, 1 year, then annually to 3 years
The change of peak flow rate (Qmax)
Measured: 1 month, 3 months, 6 months, 1 year, then annually to 3 years
Post void residual urine volume (PVR）
Measured: 1 month, 3 months, 6 months, 1 year, then annually to 3 years
Quality of life (QoL) questionnaire
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.
Measured: 1 month, 3 months, 6 months, 1 year, then annually to 3 years
Ejective function (MSHQ-EjD)
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.
Measured: 1 month, 3 months, 6 months, 1 year, then annually to 3 years
The change of International Index of Erectile Function (IIEF)
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.
Measured: 1 month, 3 months, 6 months, 1 year, then annually to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Optimized Water Vapor Thermal Therapy (REZUM) in Management of Benign Prostatic Hyperplasia. The optimized methods mainly include ablation optimization and combined imaging techniques.
- Masking
- None (open label)
- Enrolment
- 58 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607094
- Sponsor's protocol ID
- IUNU-SR-103
- Status last verified
- Sep 2024
- First submitted
- 5 Sep 2024
- Last updated
- 23 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimized Water Vapor Thermal Therapy for Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT06607094
- Acronym / sponsor ID
- IUNU-SR-103
- Conditions
- Benign Prostatic Hyperplasia
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 58 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 23 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Optimized Water Vapor Thermal Therapy (REZUM) in Management of Benign Prostatic Hyperplasia. The optimized methods mainly include ablation optimization and combined imaging techniques.
| Arm | Type | Receives |
|---|---|---|
| Optimized Water Vapor Thermal Therapy | Experimental | Device: RezumThe Rezum System is designed to treat patients with urinary symptoms associated with BPH. |
Who may qualify
- Ages
- 45 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RezumThe 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. | Device | Optimized Water Vapor Thermal Therapy |
Primary outcome
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.
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Rezum in people with Benign Prostatic Hyperplasia, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Qun Lu, PhD (8615195856020, luqun_1989@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
International Prostate Symptom Score (IPSS) change from baseline to 3 months. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2024.