Primary sponsors | Société Internationale d'Urologie |
Secondary sponsors (if any) | |
Overall study status | Ongoing |
Recruitment status | Recruiting |
Descriptive Information |
Study rationale | Due to a growing and ageing population, cases of benign prostatic hyperplasia (BPH) have been on a steady rise. Studies show that by age 80, 90% of men experience BPH.[1] Thus, treatment of BPH is one of the most performed surgical procedures in urology. Over the past few decades there has been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been 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 analyse 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. |
Study objectives | The purpose of this study is to develop a global, multi-centre BPH registry tracking baseline data with follow-up data for at least 3 years, and thereby analyse demographic patterns, comorbidities, exacerbation, severity, and intervention selection for patients undergoing surgical treatments for BPH, to assess practice patterns (region-specific) for various surgical treatments for BPH, and to assess key outcomes (efficacy and safety) for surgical 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. It aims to facilitate the identification of areas of interest for underrepresented regions and guide the implementation of regionally specific and relevant RCTs. |
Medical condition | Benign Prostatic Hyperplasia with LUTS |
Study population | All patients >18 years with symptomatic BPH with LUTS who are planned for medical or surgical intervention are eligible for this study. |
Treatment type | N/A |
Primary outcome measures | Comparing mean score of the following measures at baseline through follow-up: Efficacy measures • IPSS • QoL Safety measures • PVR • Complications |
Secondary outcome measures | Efficacy measures • Prostate volume (cc) • Qmax Sexual function measures • SHIM • MSHQ-EjD |
Recruitment Information |
Date of first enrollment | 2022-08-30 |
Study start date | 2022-08-18 |
Estimated study completion date | 2025-08-18 |
Estimated primary completion date | 2023-08-18 |
Eligibility | Records and cases of all men ≥18 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. |
Inclusion criteria |
- A clinical history consistent with Benign Prostatic Hyperplasia
- Prescribed medication or surgical intervention for BPH
|
Exclusion criteria |
- Patients <18 years old
- Patient with no planned intervention
|
Primary Facility Contact |
Title | Dr. |
First name | Mihir |
Last name | Desai |
Telephone | +1 (323) 865-3700 |
Email | [email protected] |
Overall Study Officials |
First name | Mihir |
Last name | Desai |
Degree | MD, MPH |
Organizational affiliation | University of Southern California |
Official's role | Study Principal Investigator |
Centers/Contacts |
Dr. Dean Elterman, Canada
Dr. Mélanie Aubé-Peterkin, Canada
Dr. Reynaldo Gomez, Chile
Prof. Stavros Gravas, Cyprus
Dr. Mauro Gacci, Italy
Prof. Bulent Erkurt, Turkey
Dr. Ranan Dasgupta, United Kingdom
Dr. Mihir Desai, United States
|
Publications/Documents |
Publication status | Pending |
If other, please specify | |
Publication link | |