Recruiting

Observational Study

Sponsor:

Société Internationale d'Urologie

Code:

NCT05543200

Conditions

Benign Prostatic Hyperplasia

Lower Urinary Tract Symptoms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Benign Prostatic Hyperplasia

Lower Urinary Tract Symptoms

Study ID

NCT05543200

Start date

Mar 13, 2023

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

7500 participants

Anticipated

Interventions and Outcome Measures

Arms

All Participants

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

Primary outcome measure

  • International Prostate Symptom Score (IPSS) [ Time Frame: 36 months ]
  • Quality of Life (QoL) [ Time Frame: 36 months ]
  • Post-Void Residual (PVR) [ Time Frame: 36 months ]
  • Complications (including incontinence) [ Time Frame: 36 months ]

Central Contacts and Locations

Central contacts

Mihir Desai, MD

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

Eduardo Gutierrez, PhD

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

Locations

Keck Medicine of USC

Recruiting

Los Angeles, California, United States, 90089

Principal Investigator:

Mihir Desai, MD

Toronto Western Hospital, University Health Network

Recruiting

Toronto, Ontario, Canada

Contacts

Iris Chan

Iris.Chan2@uhn.ca

Principal Investigator:

Dean Elterman, MD, MSc, FRCSC

McGill University Health Centre

Recruiting

Montreal, Quebec, Canada

Contacts

Mélanie Aubé-Peterkin, MD

melanieaubep@gmail.com

Principal Investigator:

Mélanie Aubé-Peterkin, MD

More Information

Sponsor

Société Internationale d'Urologie

Last update posted

Aug 13, 2026

Last verified

Aug, 2026

Keywords

  • BPH, Registry, LUTS

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Société Internationale d'Urologie on 2026-08-13.