Unilateral vs Bilateral Embolization of the Prostate ArteriesNCT04006431
Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral Embolization
An observational study of Unilateral vs Bilateral Embolization of the Prostate Arteries, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Unilateral vs Bilateral Embolization of the Prostate Arteries
- What is being tested?
- embolization
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 4 Apr 2019to 31 Dec 2022
- Phase
- Observational
- 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 70 years and older
- All sexes
- Older adult
Study population: Elderly patients (>70 years of age) with contraindications to surgery, chronically probed
Who may be able to join
- Elderly patients (>70 years old)
- with contraindications to surgery,
- with a chronic urinary catheterization
Who cannot join
- <70 years old
- without contraindications to surgery
- without chronic urinary catheterization
Trial locations and contacts
1 site in 1 country.
About this study
Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries
Read the detailed description
Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries.
Method of observation or investigation chosen:
Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.
Origin and nature of the data Patient's medical record: imaging stored in the PACS to confirm unilateral or bilateral embolization, perform measurements of prostate volume, urological medical record to see the effectiveness of embolization in terms of disundation, comfort of life, tolerance of embolization, effectiveness in terms of urination (IPSS score)
Data flow mode:
Data stored in redcap.
- Being tested
- embolization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
embolizationOther
Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.
What is being measured
The primary outcome is the main question the study is designed to answer.
the effectiveness of embolization
International prostate score symptomsScore
Measured: at one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start4 Apr 2019
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Unilateral vs Bilateral Embolization of the Prostate ArteriesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04006431
- Sponsor's protocol ID
- Local/2018
- Status last verified
- Jul 2019
- First submitted
- 1 Jul 2019
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Frandon J, Belaouni A, Pellerin O, Thiounn N, Serrand C, Droupy S, Petitpierre F, Vernhet-Kovacsik H, Murez T, Vidal V, Ghelfi J, Pagnoux G, Codas R, de Forges H, Beregi JP, Sapoval M. Efficacy and safety of prostate artery embolization for patients with lower urinary tract symptoms and indwelling urinary catheter: A retrospective multicenter study. Diagn Interv Imaging. 2022 Dec;103(12):601-606. doi: 10.1016/j.diii.2022.07.002. Epub 2022 Aug 10.
PubMed 35963778
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Embolization in Chronically Surveyed Patients: Effectiveness of Unilateral vs. Bilateral Embolization
- ClinicalTrials.gov ID
- NCT04006431
- Acronym / sponsor ID
- Local/2018
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 4 Apr 2019 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jul 2019 (actual)
- 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.
Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries
Detailed description
Prostate embolization is an alternative treatment to trans urethral prostate resection in the context of benign prostatic hypertrophy. This embolization treatment is also of interest in patients with chronic anuria surveyed in relation to their prostatic hypertrophy for disundation. This survey causes discomfort and urinary tract infection. It is a population with tortuous arteries, a severe atherosclerotic overload making embolizations complex and long. Often, only unilateral embolization is possible. The purpose of this study is to compare the effectiveness in terms of disundation of unilateral vs. bilateral embolization of the prostatic arteries.
Method of observation or investigation chosen:
Retrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries.
Origin and nature of the data Patient's medical record: imaging stored in the PACS to confirm unilateral or bilateral embolization, perform measurements of prostate volume, urological medical record to see the effectiveness of embolization in terms of disundation, comfort of life, tolerance of embolization, effectiveness in terms of urination (IPSS score)
Data flow mode:
Data stored in redcap.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Age groups
- Older adult
- Study population
- Elderly patients (>70 years of age) with contraindications to surgery, chronically probed
Key inclusion criteria (3 listed)
- Elderly patients (>70 years old)
- with contraindications to surgery,
- with a chronic urinary catheterization
Key exclusion criteria (3 listed)
- <70 years old
- without contraindications to surgery
- without chronic urinary catheterization
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 |
|---|---|---|
| embolizationRetrospective, observational collection with division of patients into two groups according to unilateral or bilateral embolization of the porstatic arteries. | Other | – |
Primary outcome
the effectiveness of embolization
Time frame: at one month
International prostate score symptomsScore
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2025.
- Results publication: PubMed 35963778Frandon J, Belaouni A, Pellerin O, Thiounn N, Serrand C, Droupy S, Petitpierre F, Vernhet-Kovacsik H, Murez T, Vidal V, Ghelfi J, Pagnoux G, Codas R, de Forges H, Beregi JP, Sapoval M. Efficacy and safety of prostate artery embolization for patients with lower urinary tract symptoms and indwelling urinary catheter: A retrospective multicenter study. Diagn Interv Imaging. 2022 Dec;103(12):601-606. doi: 10.1016/j.diii.2022.07.002. Epub 2022 Aug 10.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Unilateral vs Bilateral Embolization of the Prostate Arteries, run by Centre Hospitalier Universitaire de Nīmes at 1 site 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 3 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: finished, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
the effectiveness of embolization (time frame: at one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04006431, which also lists 1 linked publication.
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 1 Dec 2025.