Prostatic Hypertrophy, BenignPARIS1NCT02689830
Prostate Embolization for Acute Urinary Retention Study
A study testing Bead Block in people with Prostatic Hypertrophy, Benign, run by ClinSearch at 3 sites in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostatic Hypertrophy, Benign
- What is being tested?
- Bead Block
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesFrance
- Study dates
- Mar 2016to Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 17Show fewer
- 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
Trial locations and contacts
3 sites in 1 country.
France3 sites
Hôpital Saint-Louis
Paris, 75010
Hôpital Cochin
Paris, 75014
Hôpital Européen Georges Pompidou
Paris, 75015
About this study
Official title: Prostate Embolization for Acute Urinary Retention Study (PARIS 1): An Open-label Prospective Study
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).
Read the detailed description
This is an open-label prospective, multicenter (centralized procedure), single arm, sequentially enrolling study. Twenty subjects will be enrolled in the study.
Patient will be referred by the attending urologists after failure of the currently recommended approach of Trial WithOut Catheter (TWOC) and alpha-adrenergic receptor (AR) blockers.
It is expected that all AUR cases referred to the local urological clinic will be considered for inclusion in the trial. A trial log book will be completed by the referring local urologist in order to obtain preliminary data on the applicability of the trial to all AUR comers in the institution. This log book will be limited to a very simple questionnaire to ensure high rate of completion by the attending resident/fellow (Patients age, size of prostate, previous Benign Prostate Hypertrophy symptoms, renal function). It will be used in order to assess the external validity of this first phase trial and will be a help to design the potential next step trial.
When a patient will present with AUR in the corresponding urological clinic, the PI and Clinical research coordinator will be informed by a short text message, fax or e-mail in order to prepare the following process.
Patient will be informed by the urologist of the ongoing research project. In summary, this will consist in informing the patient that the first step is TWOC and in case of failure of TWOC several options are offered including PAE in the trial setting. Inclusion of the patient will considered only in case of failure of TWOC.
If the patient is willing to participate, patient will be seen in clinic by the Principal Investigator or co-investigator in order to inform him of the protocol and obtain signed informed consent.
PAE will be scheduled upon the first contact to make sure that PAE is performed in a short delay following failure of TWOC. The goal is to perform PAE in the week following recatheterization. For practical reasons this delay might be extended and will be recorded in the Case Report Form.
- Conditions
- Prostatic Hypertrophy, Benign
- Being tested
- Bead Block
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bead BlockDevice
Prostate embolization
| Study group | Role | What they receive |
|---|---|---|
| Bead Block microspheres | Experimental | Prostate embolization Receives: Device: Bead Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure success
percentage of patients free of Foley and/or any prostate surgery
Measured: 6 months after PAE
Secondary outcomes (21)
Percentage of procedure related or contributed complications
Measured: 1 week after PAE
Percentage of immediate technical success of embolization
Percentage of bilateral embolization
Measured: 5 minutes after the beginning of the procedure
Cumulative number of per-procedure angiographic and clinical complications
according to the Society of Interventional Radiology and Dindo classifications
Measured: 24 hours after PAE
Immediate technical success of embolization
percentage of unilateral versus percentage of bilateral embolization
Measured: 5 minutes after the beginning of the procedure
Comparison of International Prostate Symptom Score
Measured: between pre-PAE and 3 months post-PAE
Comparison of International Index of Erectile Function
Measured: between pre-PAE and 3 months post-PAE
Comparison of Quality of Life Questionnaire
Measured: between pre-PAE and 3 months post-PAE
Comparison of International Prostate Symptom Score
Measured: between pre-PAE and 6 months post-PAE
Comparison of International Index of Erectile Function
Measured: between pre-PAE and 6 months post-PAE
Comparison of Quality of Life Questionnaire
Measured: between pre-PAE and 6 months post-PAE
Number of re-catheterization
Measured: 6 months after PAE
Time of re-catheterization
Measured: 6 months after PAE
Time until TransUrethral Resection of the Prostate or open surgery
Measured: 6 months
Cumulative number of days with bladder catheter
Measured: between PAE and 6 months post-PAE
Number of patients free of bladder catheter
Measured: between PAE and 6 months post-PAE
Number of cumulated hospitalization days
Measured: between initial AUR and 6 months post-PAE
Number of cumulated hospitalization days
Measured: between PAE and 6 months post-PAE
Total number of consultations
consultations with interventional radiologist and/or urologist
Measured: between PAE and 6 months post-PAE
Prostate volume
Measured with MRI or ultrasound
Measured: 6 months
Comparison of the number of Benign Prostate Hypertrophy medication
Measured: before and 3 months after PAE
Comparison of the number of Benign Prostate Hypertrophy medication
Measured: before and 6 months after PAE
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionJul 2017
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic Hypertrophy, BenignStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- ClinSearch
- Sponsor type
- University, hospital or other
- Collaborators
- Biocompatibles UK Ltd, European Georges Pompidou Hospital
- Responsible party
- Sponsor
- Investigators
- Marc SAPOVAL, Principal investigator, HEGP, Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02689830
- Sponsor's protocol ID
- SA-112043
- Acronym
- PARIS1
- Status last verified
- Jul 2017
- First submitted
- 10 Feb 2016
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Global results will be available for patients.
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Embolization for Acute Urinary Retention Study (PARIS 1): An Open-label Prospective Study
- ClinicalTrials.gov ID
- NCT02689830
- Acronym / sponsor ID
- PARIS1 / SA-112043
- Conditions
- Prostatic Hypertrophy, Benign
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- ClinSearchUniversity, hospital or other
- Collaborators
- Biocompatibles UK Ltd, European Georges Pompidou Hospital
- Study start
- Mar 2016 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Dec 2017 (estimated)
- First posted
- 24 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
This is an open-label prospective, multicenter (centralized procedure), single arm, sequentially enrolling study. Twenty subjects will be enrolled in the study.
Patient will be referred by the attending urologists after failure of the currently recommended approach of Trial WithOut Catheter (TWOC) and alpha-adrenergic receptor (AR) blockers.
It is expected that all AUR cases referred to the local urological clinic will be considered for inclusion in the trial. A trial log book will be completed by the referring local urologist in order to obtain preliminary data on the applicability of the trial to all AUR comers in the institution. This log book will be limited to a very simple questionnaire to ensure high rate of completion by the attending resident/fellow (Patients age, size of prostate, previous Benign Prostate Hypertrophy symptoms, renal function). It will be used in order to assess the external validity of this first phase trial and will be a help to design the potential next step trial.
When a patient will present with AUR in the corresponding urological clinic, the PI and Clinical research coordinator will be informed by a short text message, fax or e-mail in order to prepare the following process.
Patient will be informed by the urologist of the ongoing research project. In summary, this will consist in informing the patient that the first step is TWOC and in case of failure of TWOC several options are offered including PAE in the trial setting. Inclusion of the patient will considered only in case of failure of TWOC.
If the patient is willing to participate, patient will be seen in clinic by the Principal Investigator or co-investigator in order to inform him of the protocol and obtain signed informed consent.
PAE will be scheduled upon the first contact to make sure that PAE is performed in a short delay following failure of TWOC. The goal is to perform PAE in the week following recatheterization. For practical reasons this delay might be extended and will be recorded in the Case Report Form.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bead Block microspheres | Experimental | Device: Bead BlockProstate embolization |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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)
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bead BlockProstate embolization | Device | Bead Block microspheres |
Primary outcome
Procedure success
Time frame: 6 months after PAE
percentage of patients free of Foley and/or any prostate surgery
21 secondary outcomes
Percentage of procedure related or contributed complications
Time frame: 1 week after PAE
Percentage of immediate technical success of embolization
Time frame: 5 minutes after the beginning of the procedure
Cumulative number of per-procedure angiographic and clinical complications
Time frame: 24 hours after PAE
Immediate technical success of embolization
Time frame: 5 minutes after the beginning of the procedure
Comparison of International Prostate Symptom Score
Time frame: between pre-PAE and 3 months post-PAE
Comparison of International Index of Erectile Function
Time frame: between pre-PAE and 3 months post-PAE
Comparison of Quality of Life Questionnaire
Time frame: between pre-PAE and 3 months post-PAE
Comparison of International Prostate Symptom Score
Time frame: between pre-PAE and 6 months post-PAE
Comparison of International Index of Erectile Function
Time frame: between pre-PAE and 6 months post-PAE
Comparison of Quality of Life Questionnaire
Time frame: between pre-PAE and 6 months post-PAE
Number of re-catheterization
Time frame: 6 months after PAE
Time of re-catheterization
Time frame: 6 months after PAE
Time until TransUrethral Resection of the Prostate or open surgery
Time frame: 6 months
Cumulative number of days with bladder catheter
Time frame: between PAE and 6 months post-PAE
Number of patients free of bladder catheter
Time frame: between PAE and 6 months post-PAE
Number of cumulated hospitalization days
Time frame: between initial AUR and 6 months post-PAE
Number of cumulated hospitalization days
Time frame: between PAE and 6 months post-PAE
Total number of consultations
Time frame: between PAE and 6 months post-PAE
Prostate volume
Time frame: 6 months
Comparison of the number of Benign Prostate Hypertrophy medication
Time frame: before and 3 months after PAE
Comparison of the number of Benign Prostate Hypertrophy medication
Time frame: before and 6 months after PAE
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2017.
- Individual participant dataSharing planned: Yes. Global results will be available for patients.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc SAPOVAL principal investigator
HEGP, Paris
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bead Block in people with Prostatic Hypertrophy, Benign, run by ClinSearch at 3 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure success (time frame: 6 months after PAE). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2017.