The FLOW Registry.

NCT07430423 | Not Yet Recruiting

• 1 other identifier: IRB25-1859
• Study Type: observational
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief 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. 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)

Outcome Measures

Primary Outcomes (3)

• Efficacy of aquablation procedure in patients with benign prostatic hyperplasia as assessed by the change in mean International Prostate Symptom Score (IPSS)

  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

  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.

  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

  Baseline and 3, 6, 12, and 24 months post-procedure

• Association between preoperative characteristics and clinical outcomes

  Baseline through 24 months post-procedure

• Rate of procedural failure requiring reoperation for benign prostatic hyperplasia

  Baseline to 24 months post-procedure

• Incidence of urethral stricture or bladder neck contracture

  12 and 24 months post-procedure

• Relationship between prostate volume reduction and prostate-specific antigen (PSA) reduction

  Baseline to 6 months post-procedure

Study Arms (1)

Benign Prostatic Hyperplasia Patients Undergoing Prostate Aquablation

Patients with benign prostatic hyperplasia undergoing aquablation of the prostate for the management of benign prostatic hyperplasia.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate

You may qualify if:

• 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.

You may not qualify if:

• Under 18 Years of age.

Sponsors & Collaborators

• University of Chicago: lead

Study Sites (1)

The University of Chicago

Chicago, Illinois, 60637, United States

Location

MeSH Terms

Conditions

Prostatic Hyperplasia

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• mahmoud khalil

  University of Chicago

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mahmoud Khalil

CONTACT

773-702-6105; mahmoud.khalil@bsd.uchicago.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036
• Last Updated: July 7, 2026

Record last verified: 2026-07

Locations

US (1)