The FLOW Registry.

July 6, 2026 updated by: University of Chicago

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Under 18 Years of age.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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 the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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
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.
Time Frame: Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation.
Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in urinary function
Time Frame: Baseline and 3, 6, 12, and 24 months post-procedure
To assess the change from baseline in urinary function
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
To identify preoperative predictors of improved outcomes .
Baseline through 24 months post-procedure
Rate of procedural failure requiring reoperation for benign prostatic hyperplasia
Time Frame: Baseline to 24 months post-procedure
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.
Baseline to 24 months post-procedure
Incidence of urethral stricture or bladder neck contracture
Time Frame: 12 and 24 months post-procedure
Incidence of urethral stricture or bladder neck contracture diagnosed during follow-up after the index procedure.
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
To analyze the correlation between prostate volume reduction (via TRUS/MRI) and PSA reduction at 6 months.
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
To assess the change from baseline in sexual function
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
To assess the change from baseline in quality of life.
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
To assess the change from baseline in sexual function
Baseline and 3, 6, 12, and 24 months post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Chicago

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: mahmoud khalil, University of Chicago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2036

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2036

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 7, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 6, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRB25-1859

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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