Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
7500 participants
OBSERVATIONAL
2023-03-13
2027-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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All Participants
All men who have a primary diagnosis of BPH with LUTS that are prescribed BPH medications or a surgical intervention.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* No treatment prescribed for BPH
18 Years
MALE
No
Sponsors
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Société Internationale d'Urologie
OTHER
Responsible Party
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Principal Investigators
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Mihir Desai, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Keck Medicine of USC
Los Angeles, California, United States
Toronto Western Hospital, University Health Network
Toronto, Ontario, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hospital Dr. Juan Morey La Unión
La Unión, , Chile
Hospital del Trabajador
Santiago, , Chile
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, , China
University of Cyprus
Nicosia, , Cyprus
Shariati Hospital
Tehran, , Iran
University of Basrah
Basra, , Iraq
Azienda Ospedaliero-Universitaria Careggi
Florence, , Italy
Sapienza University of Rome, Division of Urology, Ospedale Sant'Andrea
Rome, , Italy
American University of Beirut
Beirut, , Lebanon
Universiti Malaya
Kuala Lumpur, , Malaysia
Kati University Hospital
Kati, , Mali
Centro Medico Nacional Siglo XXI
Mexico City, , Mexico
Benue State University Teaching Hospital, Department of Surgery
Makurdi, , Nigeria
Ahmadu Bello University Teaching Hospital
Zaria, , Nigeria
Institute of Kidney Diseases Peshawar
Peshawar, , Pakistan
Lady Reading Hospital
Peshawar, , Pakistan
Hamad Medical Corporation Qatar
Doha, , Qatar
Istanbul Medipol University
Istanbul, , Turkey (Türkiye)
Imperial College Healthcare NHS Trust
London, , United Kingdom
Southend University Hospital
Southend-on-Sea, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Mihir Desai, MD
Role: primary
Ranan Dasgupta, MD
Role: primary
Related Links
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Other Identifiers
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uCARE-2022-001
Identifier Type: -
Identifier Source: org_study_id
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