BPH Global Registry

April 21, 2026 updated by: Société Internationale d'Urologie

A Global Registry of Treatments and Outcomes for Benign Prostatic Hyperplasia

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.

Study Overview

Status

Recruiting

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

7500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
      • Montreal, Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Recruiting
        • Toronto Western Hospital, University Health Network
        • Principal Investigator:
          • Dean Elterman, MD, MSc, FRCSC
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada
        • Recruiting
        • McGill University Health Centre
        • Contact:
        • Principal Investigator:
          • Mélanie Aubé-Peterkin, MD
  • Chile
      • La Unión, Chile
        • Recruiting
        • Hospital Dr. Juan Morey La Unión
        • Contact:
        • Principal Investigator:
          • Fernando Segura, MD
      • Santiago, Chile
        • Recruiting
        • Hospital del Trabajador
        • Contact:
        • Principal Investigator:
          • Reynaldo Gomez, MD
  • China
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University School of Medicine
        • Contact:
        • Principal Investigator:
          • Ben Liu, MD
  • Cyprus
      • Nicosia, Cyprus
        • Not yet recruiting
        • University of Cyprus
        • Contact:
        • Principal Investigator:
          • Satvros Gravas, MD
  • Hong Kong
      • Hong Kong, Hong Kong
        • Not yet recruiting
        • The Chinese University of Hong Kong
        • Contact:
        • Principal Investigator:
          • Alex Qinyang Liu, MD
  • Iran
      • Tehran, Iran
        • Recruiting
        • Shariati Hospital
        • Contact:
        • Principal Investigator:
          • Seyed Reza Yahyazadeh, MD
  • Iraq
      • Basra, Iraq
  • Italy
      • Florence, Italy
        • Recruiting
        • Azienda Ospedaliero-Universitaria Careggi
        • Principal Investigator:
          • Mauro Gacci, MD
        • Contact:
      • Rome, Italy
        • Recruiting
        • Sapienza University of Rome, Division of Urology, Ospedale Sant'Andrea
        • Contact:
        • Principal Investigator:
          • Cosimo De Nunzio, MD, PhD
  • Lebanon
      • Beirut, Lebanon
        • Recruiting
        • American University of Beirut
        • Contact:
        • Principal Investigator:
          • Albert El Hajj, MD
  • Malaysia
      • Kuala Lumpur, Malaysia
        • Recruiting
        • Universiti Malaya
        • Contact:
        • Principal Investigator:
          • Shanggar Kuppusamy, MD, PhD
  • Mali
      • Kati, Mali
        • Recruiting
        • Kati University Hospital
        • Contact:
        • Principal Investigator:
          • Idrissa Sissoko, MD
  • Mexico
      • Mexico City, Mexico
        • Recruiting
        • Centro Médico Nacional Siglo XXI
        • Contact:
        • Principal Investigator:
          • Laura Coretta Mejia Rios, MD
  • Nigeria
      • Makurdi, Nigeria
        • Recruiting
        • Benue State University Teaching Hospital, Department of Surgery
        • Contact:
        • Principal Investigator:
          • Christian Agbo, MD
      • Zaria, Nigeria
        • Recruiting
        • Ahmadu Bello University Teaching Hospital
        • Contact:
        • Principal Investigator:
          • Nasir Oyelowo, MD
  • Pakistan
      • Peshawar, Pakistan
        • Recruiting
        • Lady Reading Hospital
        • Contact:
        • Principal Investigator:
          • Muhammad Asif, MD
      • Peshawar, Pakistan
        • Recruiting
        • Institute of Kidney Diseases Peshawar
        • Contact:
        • Principal Investigator:
          • Abdul Haseeb, MD
  • Qatar
      • Doha, Qatar
        • Recruiting
        • Hamad Medical Corporation Qatar
        • Contact:
        • Principal Investigator:
          • Kamran Bhatti, MD
  • South Korea
      • Seongnam, South Korea
        • Not yet recruiting
        • Seoul National University Bundang Hospital
        • Contact:
        • Principal Investigator:
          • Sung Kyu Hong, MD
        • Sub-Investigator:
          • Sang Hun Song, MD
  • Turkey (Türkiye)
      • Istanbul, Turkey (Türkiye)
        • Recruiting
        • Istanbul Medipol University
        • Contact:
        • Principal Investigator:
          • Bulent Erkurt, MD
  • United Kingdom
      • London, United Kingdom
        • Not yet recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
          • Ranan Dasgupta, MD
        • Principal Investigator:
          • Ranan Dasgupta, MD
      • Southend-on-Sea, United Kingdom
        • Recruiting
        • Southend University Hospital
        • Contact:
        • Principal Investigator:
          • Daben Dawam, MD
  • United States
    • California
      • Los Angeles, California, United States, 90089
        • Recruiting
        • Keck Medicine of USC
        • Contact:
          • Mihir Desai, MD
        • Principal Investigator:
          • Mihir Desai, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients >18 years with symptomatic BPH with LUTS who are planned for medical or surgical intervention are eligible for this study.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
All Participants
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?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
International Prostate Symptom Score (IPSS)
Time Frame: 36 months
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
Post-Void Residual (PVR)
Time Frame: 36 months
Comparison of mean PVR change between baseline and at each follow-up during the course of the study.
36 months
Complications (including incontinence)
Time Frame: 36 months
Type and Clavien grade incidences across all surgical interventions.
36 months
Quality of Life (QoL)
Time Frame: 36 months
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prostate Volume (cc)
Time Frame: 36 months
Comparison of mean Prostate Volume change between baseline and at each follow-up during the course of the study.
36 months
Qmax
Time Frame: 36 months
Comparison of mean Qmax change between baseline and at each follow-up during the course of the study.
36 months
Sexual Health Inventory for Men (SHIM)
Time Frame: 36 months
Comparison of mean SHIM score change between baseline and at each follow-up during the course of the study.
36 months
Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD)
Time Frame: 36 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Société Internationale d'Urologie

Investigators

  • Principal Investigator: Mihir Desai, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2023

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

March 1, 2027

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 15, 2022

First Posted (Actual)

September 16, 2022

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • uCARE-2022-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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