Collaborative Applied Research

Registry Studies

A Global Registry of Treatments and Outcomes for Benign Prostatic Hyperplasia (ClinicalTrisls.gov:NCT05543200, uCARE 2022-001)

Primary sponsorsSociété Internationale d'Urologie
Secondary sponsors (if any)
Overall study statusOngoing
Recruitment statusRecruiting

Descriptive Information

Study rationale

Due to a growing and ageing population, cases of benign prostatic hyperplasia (BPH) have
been on a steady rise. Studies show that by age 80, 90% of men experience BPH.[1] Thus, treatment of BPH is one of the most performed surgical procedures in urology. Over the past few
decades there has been an increasing development of newer surgical treatment options. Additionally, the outcome parameters for BPH treatments have been 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 analyse 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.

Study objectives

The purpose of this study is to develop a global, multi-centre BPH registry tracking baseline
data with follow-up data for at least 3 years, and thereby analyse demographic patterns, comorbidities, exacerbation, severity, and intervention selection for patients undergoing surgical treatments for BPH, to assess practice patterns (region-specific) for various surgical treatments for BPH, and to assess key outcomes (efficacy and safety) for surgical 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. It aims to facilitate the identification of areas of interest for underrepresented regions
and guide the implementation of regionally specific and relevant RCTs.

Medical conditionBenign Prostatic Hyperplasia with LUTS
Study populationAll patients >18 years with symptomatic BPH with LUTS who are planned for medical or surgical intervention are eligible for this study.
Treatment typeN/A
Primary outcome measures

Comparing mean score of the following measures at baseline through follow-up:
Efficacy measures
• IPSS
• QoL
Safety measures
• PVR
• Complications

Secondary outcome measures

Efficacy measures
• Prostate volume (cc)
• Qmax
Sexual function measures
• SHIM
• MSHQ-EjD

Recruitment Information

Date of first enrollment2022-08-30
Study start date2022-08-18
Estimated study completion date2025-08-18
Estimated primary completion date2023-08-18
Eligibility

Records and cases of all men ≥18 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.

Inclusion criteria
  •  A clinical history consistent with Benign Prostatic Hyperplasia
  • Prescribed medication or surgical intervention for BPH
Exclusion criteria
  • Patients <18 years old
  • Patient with no planned intervention
Primary Facility Contact
TitleDr.
First nameMihir
Last nameDesai
Telephone+1 (323) 865-3700
Email[email protected]
Overall Study Officials
First nameMihir
Last nameDesai
DegreeMD, MPH
Organizational affiliationUniversity of Southern California
Official's roleStudy Principal Investigator

Centers/Contacts

Dr. Dean Elterman, Canada
Dr. Mélanie Aubé-Peterkin, Canada
Dr. Reynaldo Gomez, Chile
Prof. Stavros Gravas, Cyprus
Dr. Mauro Gacci, Italy
Prof. Bulent Erkurt, Turkey
Dr. Ranan Dasgupta, United Kingdom
Dr. Mihir Desai, United States

Publications/Documents

Publication statusPending
If other, please specify
Publication link
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