Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05543200 |
| Other study ID # |
uCARE-2022-001 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
March 13, 2023 |
| Est. completion date |
March 2027 |
Study information
| Verified date |
March 2024 |
| Source |
Société Internationale d'Urologie |
| Contact |
Mihir Desai, MD |
| Phone |
+1 (323) 865 3700 |
| Email |
mihir.desai[@]med.usc.edu |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Benign prostatic hyperplasia (BPH) is one of the most common performed surgical procedures in
urology. Over the past few decades there have been an increasing development of newer
surgical treatment options. Additionally, the outcome parameters for BPH treatments have been
standardized. While data are available for the initial pivotal studies, post-market release
data are lacking. Under the umbrella of uCARE, we have started a prospective, ongoing
international registry for recording demographics and outcomes for patients undergoing
surgical treatments for BPH.
Description:
Due to a growing and aging population, cases of benign prostatic hyperplasia (BPH) have been
on a steady rise. Studies show that by age 80, 90% of men experience BPH. (Garraway, Lee,
Collins, 1991) Thus, treatment of BPH is one of the most performed surgical procedures in
urology. Over the past few decades there have been an increasing development of newer
surgical treatment options. Additionally, the outcome parameters for BPH treatments have been
somewhat standardized. The purpose of this study is to create an ongoing prospective registry
to record demographic data and clinical outcomes after medical therapy or different surgical
interventions for BPH. The specific aims of the registry are to analyze demographic patterns
and baseline characteristics of men undergoing surgical and medical treatments for BPH, to
assess global practice patterns for various surgical and medical treatments of BPH, and to
assess key outcomes for uni- and multi-modal treatments of BPH.
The ongoing global registry will provide important baseline data, functional outcomes, and
complications following medical and/or surgical intervention for men with symptomatic BPH.
The intention of the registry is to provide real world usage data that may be used for future
investigations. It will allow providers to identify areas of interest, areas of unusually low
usage or areas of unusual preference on a global scale. It will also shed light on global
preferences for unimodal or multimodal approaches to treatments.
The registry has been developed using novel database technology, providing an easy-to-use
user interface, which enables future creation of patient portals and Electronic Medical
Record (EMR) integration.
As this is not an experimental setting, there will be no interventions made on behalf of the
registry.
This is a prospective longitudinal ongoing registry. The study will include medical records
of all men ≥18 years old who have a primary diagnosis of BPH with Lower Urinary Tract
Symptoms (LUTS) that are prescribed BPH medications, or a surgical intervention. Data
extraction includes baseline data, peri-operative data, and follow-up data. Baseline data
includes validated patient reported outcome tools, including International Prostate Symptom
Score (IPSS), Sexual Health Inventory for Men (SHIM), Male Sexual Health Questionnaire -
Ejaculatory Dysfunction (MSHQ-EjD), as well as Quality of Life (QoL), maximum flow rate
(Qmax), Post-void residual (PVR), Prostate Specific Antigen (PSA), and Testosterone.
Complications such as Bleeding, Urinary Tract Infection (UTI), Incontinence, Stricture,
Retrograde ejaculation, and Erectile Dysfunction (ED) are also tracked from Baseline through
Follow-up.
The registry will run for 3 years with no end point for follow-up. For three years, various
research studies will be formulated, and the results will be published. The possibility of
extending the study for continued follow-up will be evaluated.
A built-in quality control using data validation during the input process decreases the
chance that invalid data will be entered or that datapoints will be omitted. Periodic audits
will be performed to verify accuracy of source data by our audit committee based on our audit
committee guidelines.
Records and cases of all men with a primary diagnosis of BPH with LUTS that are prescribed
BPH medications, or a surgical intervention will be identified and included in the registry.
All data is hashed (i.e., protected from decryption) except for a medical record number
(MRN), which will be used to add follow-up data to the patient's record. This number is
encrypted and linked to the hashed and randomly generated institution code. For security
purposes, biographical information is not saved on the registry.
The registry provides secure access to registered users using a web browser. Registrations
are site-specific, which means that users can only access the data that is specific to their
own site. The registry application and databases are hosted on secure, encrypted servers
behind a firewall. They can only be accessed by registered users via a specific port.
