Benign Prostatic HyperplasiaNCT04997369
Catheterless Water Vapor Therapy for the Treatment of BPH
A study testing Rezum in people with Benign Prostatic Hyperplasia, run by Northwell Health at 1 site in United States.
Trial summary
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. Read more about this study
- Who is it for?
- Ages 40 to 80 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
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to Jun 2027
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 40 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male subject of 40 - 80 years of age
- Has provided informed consent
- Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement
- Able to complete self-administered questionnaires
- Is a surgical candidate for Rezum
- Has medical record documentation of Qmax < 15 ml/s
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- Has medical record documentation of prostate volume from 30-80 ml by transrectal ultrasound (TRUS)
- Has a bladder contractility index score ≥ 100, calculated by detrusor pressure at Qmax (pDet@qmax) + (5xQmax).
- Willing to undergo pressure-flow studies to calculate BCI prior to surgical intervention.
- Has serum creatinine within the normal range.
- Able to perform intermittent catheterization.
Who cannot join
- Has a life expectancy < 2 years
- Is currently enrolled in or plans to enroll in any concurrent drug or device study
- Has an active infection (e.g., urinary tract infection or prostatitis)
- Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
- Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
- Has been diagnosed with 2 or more urethral strictures and/or bladder neck contractures within 5 years
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- Has a diagnosis of lichen sclerosis
- Has a diagnosis of neurogenic bladder or other neurologic disorder that affects bladder function
- Has a diagnosis of polyneuropathy (e.g., diabetic)
- Has a history of lower urinary tract surgery
- Has a diagnosis of stress urinary incontinence that requires treatment or daily pad or device use
- Has an inability to perform intermittent self-catheterization
- Has been catheterized or has a post-void residual (PVR) of > 400 ml in the 14 days prior to the surgical procedure
- Has a current diagnosis of bladder stones
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Rezum
- Keywords
- Water Vapor Therapy
- 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
Also called Water vapor therapy
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH).
| Study group | Role | What they receive |
|---|---|---|
| Catheterless group | Experimental | Not described Receives: Device: Rezum |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Measured: Baseline, 36 months
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Measured: Baseline, 36 months
Secondary outcomes (2)
Changes in urinary symptoms as measured by changes in IPSS.
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Measured: Baseline, 36 months
Changes in urinary symptoms as measured by changes in Qmax at 36 months
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
Measured: Baseline, 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start13 Oct 2021
- Primary completion21 Jun 2024
- Study completionJun 2027 (estimated)
Why it stopped: Principal Investigator changing locations.
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 Northwell HealthThe 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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northwell Health
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Scientific Corporation
- Responsible party
- Sponsor
- Investigators
- Bilal Chughtai, MD, Principal investigator, Weill Medical College of Cornell University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04997369
- Sponsor's protocol ID
- 20-02021474
- Status last verified
- Dec 2024
- First submitted
- 29 Jul 2021
- Last updated
- 30 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Multicenter Assessment of Catheter-less Water Vapor Therapy (Rezum) for the Treatment of Benign Prostatic Hyperplasia (BPH)
- ClinicalTrials.gov ID
- NCT04997369
- Acronym / sponsor ID
- 20-02021474
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- Water Vapor Therapy
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: Principal Investigator changing locations.
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Northwell HealthUniversity, hospital or other
- Collaborators
- Boston Scientific Corporation
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 21 Jun 2024 (actual)
- Study completion
- Jun 2027 (estimated)
- First posted
- 9 Aug 2021 (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.
The Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). One of the limitations of the technology is the need for post-operative catheterization up to 5 days. The aim of this study is to assess the feasibility of employing Catheterless Rezum post-operatively in patients with normal or strong bladder contractility. Upon a positive outcome of interim analysis, the effectiveness of Catheterless Rezum will be assessed at five sites for the multicenter phase.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Catheterless group | Experimental | Device: Rezum |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male subject of 40 - 80 years of age
- Has provided informed consent
- Has a diagnosis of bladder outlet obstruction due to benign prostatic enlargement
- Able to complete self-administered questionnaires
- Is a surgical candidate for Rezum
Key exclusion criteria (14 listed)
- Has a life expectancy < 2 years
- Is currently enrolled in or plans to enroll in any concurrent drug or device study
- Has an active infection (e.g., urinary tract infection or prostatitis)
- Has a diagnosis of or has received treatment for chronic prostatitis or chronic pelvic pain syndrome (e.g., nonbacterial chronic prostatitis)
- Has been diagnosed with a urethral stricture or bladder neck contracture within the last 180 days
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 |
|---|---|---|
| RezumAlso: Water vapor therapyThe Rezum system is an ablative procedure for patients with benign prostatic hyperplasia (BPH). | Device | Catheterless group |
Primary outcome
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS).
Time frame: Baseline, 36 months
The outcome will be assessed based on a 6.0-point average improvement in the IPSS score. Higher scores indicate greater symptom severity and lower scores indicate less symptom severity.
Feasibility of Catheterless Rezum as measured by changes in the maximum urinary flow rate (Qmax).
Time frame: Baseline, 36 months
The outcome will be assessed based on a 2.5-point average improvement in Qmax compared to baseline. Higher Qmax values indicate less urinary obstruction while lower Qmax values correspond to increased urinary obstruction.
2 secondary outcomes
Changes in urinary symptoms as measured by changes in IPSS.
Time frame: Baseline, 36 months
Changes in urinary symptoms as measured by changes in Qmax at 36 months
Time frame: Baseline, 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2024.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Bilal Chughtai, MD principal investigator
Weill Medical College of Cornell University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rezum in people with Benign Prostatic Hyperplasia, run by Northwell Health at 1 site in United States.
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 11 inclusion and 14 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: paused, as of the sponsor's last update on 30 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Catheterless Rezum as measured by changes in the International Prostate Symptom Score (IPSS). (time frame: Baseline, 36 months). The study lists 2 primary outcomes in all. 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 30 Dec 2024.