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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Benign Prostatic Hyperplasia Patients Undergoing Prostate Aquablation | Patients with benign prostatic hyperplasia undergoing aquablation of the prostate for the management of benign prostatic hyperplasia. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | Number of incidences of Clavien-Dindo Grade ≥ II complications | 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. | Baseline to follow up every 6 months (at minimum) for 2 years, and annually through 10 years of total after prostate aquablation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in urinary function | To assess the change from baseline in urinary function | Baseline and 3, 6, 12, and 24 months post-procedure |
| Association between preoperative characteristics and clinical outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with benign prostatic hyperplasia undergoing Aquablation of the prostate
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mahmoud Khalil | Contact | 773-702-6105 | mahmoud.khalil@bsd.uchicago.edu |
| Name | Affiliation | Role |
|---|---|---|
| mahmoud khalil | University of Chicago | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The University of Chicago | Chicago | Illinois | 60637 | United States |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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To identify preoperative predictors of improved outcomes .
| 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. | 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. | 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. | 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 | 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. | 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 | Baseline and 3, 6, 12, and 24 months post-procedure |
| D052801 |
| Male Urogenital Diseases |