Prostatic Hypertrophy, Benign Clinical Trial
— PARIS1Official title:
Prostate Embolization for Acute Urinary Retention Study (PARIS 1): An Open-label Prospective Study
Verified date | July 2017 |
Source | ClinSearch |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess the feasibility and safety of Prostate Artery Embolization (PAE) in patients suffering of Acute Urinary Retention (AUR) in the context Benign Prostatic Hypertrophy (BPH).
Status | Active, not recruiting |
Enrollment | 20 |
Est. completion date | December 2017 |
Est. primary completion date | July 2017 |
Accepts healthy volunteers | No |
Gender | Male |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - AUR Patients presenting with a first episode of AUR related to BPH (no matter if previously known or not) AND - Failure of at least one TWOC AND - Prostate size > or = 50 ml (ultrasound measurement) Exclusion Criteria: - Known hypocontractile bladder - AUR related to other causes (Acute prostatitis or documented Prostate cancer) - Severe iodine allergy - Known prostate cancer - Known ongoing acute or chronic prostatitis - On-going acute pyelonephritis or septicemia from urinary origin - Patient refusing PAE - Severe renal failure (creatinine Clearance < 20 ml/min (MDRD) - Contra-indication to AR blockers (postural hypotension micturition syncope) - Contra-indication to anticoagulants - Patient catheterized with a suspubian catheter - Patient <18 - Patients who are prisoners - Patients who are mentally incapacitated - Patients participating in an investigational study involving the peripheral vasculature - Patients unable or unwilling to provide written informed consent - Patients ineligible for pelvic angiography and embolization including severe atheromatous condition or any anatomical condition |
Country | Name | City | State |
---|---|---|---|
France | Hôpital Cochin | Paris | |
France | Hôpital Européen Georges Pompidou | Paris | |
France | Hôpital Saint-Louis | Paris |
Lead Sponsor | Collaborator |
---|---|
ClinSearch | Biocompatibles UK Ltd, European Georges Pompidou Hospital |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Procedure success | percentage of patients free of Foley and/or any prostate surgery | 6 months after PAE | |
Secondary | Percentage of procedure related or contributed complications | 1 week after PAE | ||
Secondary | Percentage of immediate technical success of embolization | Percentage of bilateral embolization | 5 minutes after the beginning of the procedure | |
Secondary | Cumulative number of per-procedure angiographic and clinical complications | according to the Society of Interventional Radiology and Dindo classifications | 24 hours after PAE | |
Secondary | Immediate technical success of embolization | percentage of unilateral versus percentage of bilateral embolization | 5 minutes after the beginning of the procedure | |
Secondary | Comparison of International Prostate Symptom Score | between pre-PAE and 3 months post-PAE | ||
Secondary | Comparison of International Index of Erectile Function | between pre-PAE and 3 months post-PAE | ||
Secondary | Comparison of Quality of Life Questionnaire | between pre-PAE and 3 months post-PAE | ||
Secondary | Comparison of International Prostate Symptom Score | between pre-PAE and 6 months post-PAE | ||
Secondary | Comparison of International Index of Erectile Function | between pre-PAE and 6 months post-PAE | ||
Secondary | Comparison of Quality of Life Questionnaire | between pre-PAE and 6 months post-PAE | ||
Secondary | Number of re-catheterization | 6 months after PAE | ||
Secondary | Time of re-catheterization | 6 months after PAE | ||
Secondary | Time until TransUrethral Resection of the Prostate or open surgery | 6 months | ||
Secondary | Cumulative number of days with bladder catheter | between PAE and 6 months post-PAE | ||
Secondary | Number of patients free of bladder catheter | between PAE and 6 months post-PAE | ||
Secondary | Number of cumulated hospitalization days | between initial AUR and 6 months post-PAE | ||
Secondary | Number of cumulated hospitalization days | between PAE and 6 months post-PAE | ||
Secondary | Total number of consultations | consultations with interventional radiologist and/or urologist | between PAE and 6 months post-PAE | |
Secondary | Prostate volume | Measured with MRI or ultrasound | 6 months | |
Secondary | Comparison of the number of Benign Prostate Hypertrophy medication | before and 3 months after PAE | ||
Secondary | Comparison of the number of Benign Prostate Hypertrophy medication | before and 6 months after PAE |
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