Benign Prostatic Hyperplasia (BPH)
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
University of Chicago
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. | Baseline to 30 days post-aquablation | Number of incidences of Clavien-Dindo Grade ≥ II complications |
| 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
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in urinary function | Baseline and 3, 6, 12, and 24 months post-procedure | To assess the change from baseline in urinary function |
| Association between preoperative characteristics and clinical outcomes | Baseline through 24 months post-procedure | To identify preoperative predictors of improved outcomes . |
| Rate of procedural failure requiring reoperation for benign prostatic hyperplasia | 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. |
| Incidence of urethral stricture or bladder neck contracture | 12 and 24 months post-procedure | Incidence of urethral stricture or bladder neck contracture diagnosed during follow-up after the index procedure. |
| Relationship between prostate volume reduction and prostate-specific antigen (PSA) reduction | Baseline to 6 months post-procedure | To analyze the correlation between prostate volume reduction (via TRUS/MRI) and PSA reduction at 6 months. |
| Change from baseline in sexual function as assessed by the change in Male Sexual Health Questionnaire - Ejaculation Short Form (MSHQ-EjD) | Baseline and 3, 6, 12, and 24 months post-procedure | To assess the change from baseline in sexual function |
| Change from baseline in quality of life scores as assess by the The International Prostate Symptom Score (IPSS-QoL) | Baseline and 3, 6, 12, and 24 months post-procedure | To assess the change from baseline in quality of life. |
| Change from baseline in sexual function as assessed by the change in SEXUAL HEALTH INVENTORY FOR MEN (SHIM) | Baseline and 3, 6, 12, and 24 months post-procedure | To assess the change from baseline in sexual function |
Countries
United States
Contacts
CONTACTMahmoud Khalil
PRINCIPAL_INVESTIGATORmahmoud khalil
University of Chicago
Outcome results
None listed