Clinical trial NCT05543200: BPH Global Registry
Official title: A Global Registry of Treatments and Outcomes for Benign Prostatic Hyperplasia
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Benign Prostatic Hyperplasia
Lower Urinary Tract Symptoms
Keywords: BPH, Registry, LUTS
Lead sponsor: Société Internationale d'Urologie
Sponsor class: OTHER
First posted: 2022-09-16
Enrollment: 7500
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: International Prostate Symptom Score (IPSS)
timeFrame: 36 months
measure: Quality of Life (QoL)
timeFrame: 36 months
measure: Post-Void Residual (PVR)
timeFrame: 36 months
measure: Complications (including incontinence)
timeFrame: 36 months
Secondary outcomes:
measure: Prostate Volume (cc)
timeFrame: 36 months
measure: Qmax
timeFrame: 36 months
measure: Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD)
timeFrame: 36 months
measure: Sexual Health Inventory for Men (SHIM)
timeFrame: 36 months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Keck Medicine of USC
state: California
city: Toronto
country: Canada
facility: Toronto Western Hospital, University Health Network
state: Ontario
city: Montréal
country: Canada
facility: McGill University Health Centre
state: Quebec
city: La Unión
country: Chile
facility: Hospital Dr. Juan Morey La Unión
city: Santiago
country: Chile
facility: Hospital del Trabajador
city: Hangzhou
country: China
facility: The First Affiliated Hospital, Zhejiang University School of Medicine
city: Nicosia
country: Cyprus
facility: University of Cyprus
city: Tehran
country: Iran, Islamic Republic of
facility: Shariati Hospital
city: Basrah
country: Iraq
facility: University of Basrah
city: Florence
country: Italy
facility: Azienda Ospedaliero-Universitaria Careggi
city: Rome
country: Italy
facility: Sapienza University of Rome, Division of Urology, Ospedale Sant'Andrea
city: Beirut
country: Lebanon
facility: American University of Beirut
city: Kuala Lumpur
country: Malaysia
facility: Universiti Malaya
city: Kati
country: Mali
facility: Kati University Hospital
city: Mexico City
country: Mexico
facility: Centro Medico Nacional Siglo XXI
city: Makurdi
country: Nigeria
facility: Benue State University Teaching Hospital, Department of Surgery
city: Zaria
country: Nigeria
facility: Ahmadu Bello University Teaching Hospital
city: Peshawar
country: Pakistan
facility: Institute of Kidney Diseases Peshawar
city: Peshawar
country: Pakistan
facility: Lady Reading Hospital
city: Doha
country: Qatar
facility: Hamad Medical Corporation Qatar
city: Istanbul
country: Turkey
facility: Istanbul Medipol University
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust
city: Southend-on-Sea
country: United Kingdom
facility: Southend University Hospital
Study officials:
affiliation: University of Southern California
name: Mihir Desai, MD
role: PRINCIPAL_INVESTIGATOR
References: