The FLOW Registry.
ConditionBenign Prostatic Hyperplasia (BPH)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorUniversity of Chicago
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Under 18 Years of age.
Trial population
Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
3,000 Participants
are grouped into 1 trial groupGroup A: Benign Prostatic Hyperplasia Patients Undergoing Prostate Aquablation
Trial outcomes
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 aquablation2
Safety of the aquablation procedure in patients with BPH.
Number of incidences of Clavien-Dindo Grade ≥ II complications
Time frame
Baseline to 30 days post-aquablation3
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
To assess the change from baseline in urinary function
Time frame
Baseline and 3, 6, 12, and 24 months post-procedure2
Association between preoperative characteristics and clinical outcomes
To identify preoperative predictors of improved outcomes .
Time frame
Baseline through 24 months post-procedure3
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.
Time frame
Baseline to 24 months post-procedure4
Incidence of urethral stricture or bladder neck contracture
Incidence of urethral stricture or bladder neck contracture diagnosed during follow-up after the index procedure.
Time frame
12 and 24 months post-procedureSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: