BPH Global Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexMale
Age18+
SponsorSociété Internationale d'Urologie
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of BPH with LUTS with prescribed medical treatment or surgical intervention
Disqualifiers
Non-symptomatic BPH
No treatment prescribed for BPH
Trial population
All patients \>18 years with symptomatic BPH with LUTS who are planned for medical or surgical intervention are eligible for this study.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
7,500 Participants
are grouped into 1 trial groupGroup A: All Participants
Trial outcomes
Primary outcomes
1
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).
Time frame
36 months2
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.
Time frame
36 months3
Post-Void Residual (PVR)
Comparison of mean PVR change between baseline and at each follow-up during the course of the study.
Time frame
36 months4
Complications (including incontinence)
Type and Clavien grade incidences across all surgical interventions.
Time frame
36 monthsSecondary outcomes
1
Prostate Volume (cc)
Comparison of mean Prostate Volume change between baseline and at each follow-up during the course of the study.
Time frame
36 months2
Qmax
Comparison of mean Qmax change between baseline and at each follow-up during the course of the study.
Time frame
36 months3
Male Sexual Health Questionnaire Ejaculatory Dysfunction (MSHQ-EjD)
Comparison of mean MSHQ-EjD score change between baseline and at each follow-up during the course of the study. The scale ranges from 1 to 15 with a higher score indicating better sexual functioning.
Time frame
36 months4
Sexual Health Inventory for Men (SHIM)
Comparison of mean SHIM score change between baseline and at each follow-up during the course of the study.
Time frame
36 monthsSponsors and contacts
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Source ClinicalTrials.gov