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NCT Number: NCT07430423

The FLOW Registry.

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.

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Key information

Conditions

Benign Prostatic Hyperplasia (BPH) Genital Diseases Genital Diseases, Male Male Urogenital Diseases Prostatic Diseases Prostatic Hyperplasia Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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.

Secondary outcomes

  1. 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

  2. Association between preoperative characteristics and clinical outcomes

    Time frame: Baseline through 24 months post-procedure

    To identify preoperative predictors of improved outcomes .

  3. 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.

  4. 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.

  5. 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.

  6. 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

  7. 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.

  8. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Mahmoud Khalil

CONTACT

[email protected]

773-702-6105

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Registry information

Official study title

The FLOW Registry: Functional and Longitudinal Outcomes With Waterjet Ablation

Important dates

Study start
2026
Primary completion
2036
Study completion
2036
First posted
Feb 24, 2026
Registry last updated
Jul 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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