BPH Global Registry

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Global Registry of Treatments and Outcomes for Benign Prostatic Hyperplasia

Conditions
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Benign Prostatic Hyperplasia, Lower Urinary Tract Symptoms

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary diagnosis of BPH with LUTS with prescribed medical treatment or surgical intervention Exclusion Criteria: Non-symptomatic BPH No treatment prescribed for BPH

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Participants<br>All men who have a primary diagnosis of BPH with LUTS that are prescribed BPH medications or a surgical intervention. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | Comparison of mean IPSS score change between baseline and at each follow-up during the course of the study. The scale goes from 0 (Mild) to 35 (Severe). | 36 months | 
| Quality of Life (QoL) | Comparison of mean QoL score change between baseline and at each follow-up during the course of the study. The scale is a single question which ranges from 0 to 6, with higher numbers indicating a worse quality of life. | 36 months | 
| Post-Void Residual (PVR) | Comparison of mean PVR change between baseline and at each follow-up during the course of the study. | 36 months | 
| Complications (including incontinence) | Type and Clavien grade incidences across all surgical interventions. | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prostate Volume (cc) | Comparison of mean Prostate Volume change between baseline and at each follow-up during the course of the study. | 36 months | 
| Qmax | Comparison of mean Qmax change between baseline and at each follow-up during the course of the study. | 36 months | 
| Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD) | Comparison of mean MSHQ-EjD score change between baseline and at each follow-up during the course of the study. The scale ranges from 1 to 15 with a higher score indicating better sexual functioning. | 36 months | 
| Sexual Health Inventory for Men (SHIM) | Comparison of mean SHIM score change between baseline and at each follow-up during the course of the study. | 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BPH, Registry, LUTS