The FLOW Registry.

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: Not yet recruiting
• Conditions: Benign Prostatic Hyperplasia (BPH)

• Study Type: Observational
• Enrollment (Estimated): 3000

Contacts and Locations

• Study Contact: Name: Mahmoud Khalil; Phone Number: 773-702-6105; Email: mahmoud.khalil@bsd.uchicago.edu

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • The University of Chicago
      • Contact: Mahmoud Khalil; Phone Number: 713-792-6105; Email: mahmoud.khalil@bsd.uchicago.edu

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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

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)		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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in urinary function	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	To identify preoperative predictors of improved outcomes .	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.	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.	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.	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	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.	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	Baseline and 3, 6, 12, and 24 months post-procedure

Collaborators and Investigators

• Sponsor: University of Chicago
• Investigators: Principal Investigator: mahmoud khalil, University of Chicago

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): December 1, 2036
• Study Completion (Estimated): December 1, 2036

Study Registration Dates

• First Submitted: January 27, 2026
• First Submitted That Met QC Criteria: February 18, 2026
• First Posted (Actual): February 24, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 17, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Hyperplasia
• Other Study ID 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