BPH Global Registry

NCT05543200 | Recruiting DMC

• 1 other identifier: uCARE-2022-001
• Study Type: observational
• Target: 7,500
• Locations: 18 countries
• Sites: 25

Brief 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.

Conditions

Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia

Keywords

BPH, Registry, LUTS

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• Prostate Volume (cc)

  36 months

• Qmax

  36 months

• Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD)

  36 months

• Sexual Health Inventory for Men (SHIM)

  36 months

Study Arms (1)

All Participants

All men who have a primary diagnosis of BPH with LUTS that are prescribed BPH medications or a surgical intervention.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Primary diagnosis of BPH with LUTS with prescribed medical treatment or surgical intervention

You may not qualify if:

• Non-symptomatic BPH
• No treatment prescribed for BPH

Sponsors & Collaborators

• Société Internationale d'Urologie: lead

Study Sites (26)

Keck Medicine of USC

Los Angeles, California, 90089, United States

RECRUITING

Toronto Western Hospital, University Health Network

Toronto, Ontario, Canada

RECRUITING

McGill University Health Centre

Montreal, Quebec, Canada

RECRUITING

University of Montreal Hospital Center

Montreal, Canada

NOT YET RECRUITING

Hospital Dr. Juan Morey La Unión

La Unión, Chile

RECRUITING

Hospital del Trabajador

Santiago, Chile

RECRUITING

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

University of Cyprus

Nicosia, Cyprus

NOT YET RECRUITING

The Chinese University of Hong Kong

Hong Kong, Hong Kong

NOT YET RECRUITING

Shariati Hospital

Tehran, Iran

RECRUITING

University of Basrah

Basra, Iraq

RECRUITING

Azienda Ospedaliero-Universitaria Careggi

Florence, Italy

RECRUITING

Sapienza University of Rome, Division of Urology, Ospedale Sant'Andrea

Rome, Italy

RECRUITING

American University of Beirut

Beirut, Lebanon

RECRUITING

Universiti Malaya

Kuala Lumpur, Malaysia

RECRUITING

Kati University Hospital

Kati, Mali

RECRUITING

Centro Medico Nacional Siglo XXI

Mexico City, Mexico

RECRUITING

Benue State University Teaching Hospital, Department of Surgery

Makurdi, Nigeria

RECRUITING

Ahmadu Bello University Teaching Hospital

Zaria, Nigeria

RECRUITING

Institute of Kidney Diseases Peshawar

Peshawar, Pakistan

RECRUITING

Lady Reading Hospital

Peshawar, Pakistan

RECRUITING

Hamad Medical Corporation Qatar

Doha, Qatar

RECRUITING

Seoul National University Bundang Hospital

Seongnam, South Korea

NOT YET RECRUITING

Istanbul Medipol University

Istanbul, Turkey (Türkiye)

RECRUITING

Imperial College Healthcare NHS Trust

London, United Kingdom

NOT YET RECRUITING

Southend University Hospital

Southend-on-Sea, United Kingdom

RECRUITING

Related Links

• Home page

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mihir Desai, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mihir Desai, MD

CONTACT

+1 (323) 865 3700; mihir.desai@med.usc.edu

Eduardo Gutierrez, PhD

CONTACT

+1 514 875-5665; eduardo.gutierrez@siu-urology.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2022
• First Posted: September 16, 2022
• Study Start: March 13, 2023
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 24, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); IT (2); TU (1); GB (2); NG (2); QA (1); LE (1); MY (1); ME (1); MA (1); CY (1); KR (1); HK (1); CL (2); CN (1); IR (1); PA (2); CA (3)