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Not yet recruiting NCT07430423

The FLOW Registry.

— Observational Benign Prostatic Hyperplasia (BPH)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Benign Prostatic Hyperplasia (BPH). Basic parameters: from 18 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The FLOW Registry: Functional and Longitudinal Outcomes With Waterjet Ablation

Overview

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.

Primary outcome measures

  • 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]
  • 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 outcome measures (8)
  • 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • The University of Chicago — Chicago

Identifiers

NCT: NCT07430423 · IRB25-1859

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗