Benign Prostatic Hyperplasia (BPH)NCT07430423
The FLOW Registry.
An observational study of Benign Prostatic Hyperplasia (BPH), run by University of Chicago at 1 site in United States.
Trial summary
The purpose of this study is to create a database and prospective registry for data collection on patients with benign prostatic hyperplasia undergoing Aquablation of the prostate. All patients undergoing Aquablation of the prostate will be enrolled in the registry. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia (BPH)
- How many people
- 3,000 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2026to Dec 2036
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate
Who may be able to join
- Male sex
- ≥18 years of age
- Diagnosis of benign prostatic hyperplasia
- Scheduled to undergo or have already undergone Aquablation as part of routine clinical care or any ongoing clinical trials
- Aquablation performed with ultrasound guided, robotic assisted waterjet. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins.
Who cannot join
- Under 18 Years of age.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
The University of Chicago
Chicago, Illinois, 60637
Mahmoud Khalil, 713-792-6105, mahmoud.khalil@bsd.uchicago.edu
About this study
Official title: The FLOW Registry: Functional and Longitudinal Outcomes With Waterjet Ablation
The purpose of this study is to create a database and prospective registry for data collection on patients with benign prostatic hyperplasia undergoing Aquablation of the prostate. All patients undergoing Aquablation of the prostate will be enrolled in the registry. Historical data from 1/1/2024- 11/30/2025 will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Benign Prostatic Hyperplasia Patients Undergoing Prostate Aquablation | Patients with benign prostatic hyperplasia undergoing aquablation of the prostate for the management of benign prostatic hyperplasia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS)
Measured: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation
Safety of the aquablation procedure in patients with BPH.
Number of incidences of Clavien-Dindo Grade ≥ II complications
Measured: Baseline to 30 days post-aquablation
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in Q max/uroflowmetry.
Measured: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation.
Secondary outcomes (8)
Change from baseline in urinary function
To assess the change from baseline in urinary function
Measured: Baseline and 3, 6, 12, and 24 months post-procedure
Association between preoperative characteristics and clinical outcomes
To identify preoperative predictors of improved outcomes .
Measured: Baseline through 24 months post-procedure
Rate of procedural failure requiring reoperation for benign prostatic hyperplasia
To determine the rate of procedural failure, defined as the need for re-operation for BPH (e.g., transurethral resection of the prostate, Holmium laser surgery) within 24 months.
Measured: Baseline to 24 months post-procedure
Incidence of urethral stricture or bladder neck contracture
Incidence of urethral stricture or bladder neck contracture diagnosed during follow-up after the index procedure.
Measured: 12 and 24 months post-procedure
Relationship between prostate volume reduction and prostate-specific antigen (PSA) reduction
To analyze the correlation between prostate volume reduction (via TRUS/MRI) and PSA reduction at 6 months.
Measured: Baseline to 6 months post-procedure
Change from baseline in sexual function as assessed by the change in Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD)
To assess the change from baseline in sexual function
Measured: Baseline and 3, 6, 12, and 24 months post-procedure
Change from baseline in quality of life scores as assess by the The International Prostate Symptom Score (IPSS-QoL)
To assess the change from baseline in quality of life.
Measured: Baseline and 3, 6, 12, and 24 months post-procedure
Change from baseline in sexual function as assessed by the change in SEXUAL HEALTH INVENTORY FOR MEN (SHIM)
To assess the change from baseline in sexual function
Measured: Baseline and 3, 6, 12, and 24 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2036 (estimated)
- Study completionDec 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic Hyperplasia (BPH)Studies of the same condition, open and under way.
- More trials run by University of ChicagoThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- mahmoud khalil, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07430423
- Sponsor's protocol ID
- IRB25-1859
- Status last verified
- Oct 2026
- First submitted
- 27 Jan 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The FLOW Registry: Functional and Longitudinal Outcomes With Waterjet Ablation
- ClinicalTrials.gov ID
- NCT07430423
- Acronym / sponsor ID
- IRB25-1859
- Conditions
- Benign Prostatic Hyperplasia (BPH)
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2036 (estimated)
- Study completion
- Dec 2036 (estimated)
- First posted
- 24 Feb 2026 (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 purpose of this study is to create a database and prospective registry for data collection on patients with benign prostatic hyperplasia undergoing Aquablation of the prostate. All patients undergoing Aquablation of the prostate will be enrolled in the registry. Historical data from 1/1/2024- 11/30/2025 will be added through chart review. Current and future patient data will be collected through chart review during the subject's clinical care. Only data available in the electronic medical record will be collected and no additional data will be collected for research purposes. No biospecimens will be collected, and there are no physical risks from study participation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benign Prostatic Hyperplasia Patients Undergoing Prostate Aquablation | – | –Patients with benign prostatic hyperplasia undergoing aquablation of the prostate for the management of benign prostatic hyperplasia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate
Key inclusion criteria (5 listed)
- Male sex
- ≥18 years of age
- Diagnosis of benign prostatic hyperplasia
- Scheduled to undergo or have already undergone Aquablation as part of routine clinical care or any ongoing clinical trials
- Aquablation performed with ultrasound guided, robotic assisted waterjet. Newer methods and instrumentation continue to be developed to ablate tissue, and these energy sources can be entered into the registry as clinical use begins.
Key exclusion criteria (1 listed)
- Under 18 Years of age.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS)
Time frame: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation
Safety of the aquablation procedure in patients with BPH.
Time frame: Baseline to 30 days post-aquablation
Number of incidences of Clavien-Dindo Grade ≥ II complications
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in Q max/uroflowmetry.
Time frame: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation.
8 secondary outcomes
Change from baseline in urinary function
Time frame: Baseline and 3, 6, 12, and 24 months post-procedure
Association between preoperative characteristics and clinical outcomes
Time frame: Baseline through 24 months post-procedure
Rate of procedural failure requiring reoperation for benign prostatic hyperplasia
Time frame: Baseline to 24 months post-procedure
Incidence of urethral stricture or bladder neck contracture
Time frame: 12 and 24 months post-procedure
Relationship between prostate volume reduction and prostate-specific antigen (PSA) reduction
Time frame: Baseline to 6 months post-procedure
Change from baseline in sexual function as assessed by the change in Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD)
Time frame: Baseline and 3, 6, 12, and 24 months post-procedure
Change from baseline in quality of life scores as assess by the The International Prostate Symptom Score (IPSS-QoL)
Time frame: Baseline and 3, 6, 12, and 24 months post-procedure
Change from baseline in sexual function as assessed by the change in SEXUAL HEALTH INVENTORY FOR MEN (SHIM)
Time frame: Baseline and 3, 6, 12, and 24 months post-procedure
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 21 Oct 2026.
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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.
mahmoud khalil principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Benign Prostatic Hyperplasia (BPH), run by University of Chicago 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 5 inclusion and 1 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 21 Oct 2026. 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?
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 Mahmoud Khalil (773-702-6105, mahmoud.khalil@bsd.uchicago.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS) (time frame: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation). The study lists 3 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 21 Oct 2026.