An observational study in Benign Prostatic Hyperplasia (BPH), sponsored by University of Chicago. Not yet recruiting at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-21.
Sponsored by University of Chicago · Observational
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.
827 studies on the registry are indexed under Prostatic Hyperplasia; 179 are open to participants now.
This study's planned enrollment of 3,000 is above the median of 250 across 177 observational studies indexed under Prostatic Hyperplasia.
Browse Prostatic Hyperplasia studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Patients with benign prostatic hyperplasia undergoing aquablation of the prostate for the management of benign prostatic hyperplasia.
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.
Number of incidences of Clavien-Dindo Grade ≥ II complications
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.
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-procedure
Association between preoperative characteristics and clinical outcomes
To identify preoperative predictors of improved outcomes .
Time frame: 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.
Time frame: 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.
Time frame: 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.
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)
To assess the change from baseline in sexual function
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)
To assess the change from baseline in quality of life.
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)
To assess the change from baseline in sexual function
Time frame: Baseline and 3, 6, 12, and 24 months post-procedure
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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