Benign Prostatic HyperplasiaPhase 3Prost-EMBOLNCT01931605
Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.
A Phase 3 study testing Prostatic arterial embolization using BeadBlock (Terumo) in people with Benign Prostatic Hyperplasia, run by University Hospital, Rouen at 1 site in France.
Trial summary
Background: Patients with indwelling urinary catheter for chronic retention due to obstructive BPH refractory to medical therapy are candidates for prostatectomy still considered as the gold standard of treatment. Read more about this study
- Who is it for?
- Ages 50 to 85 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Prostatic arterial embolization using BeadBlock (Terumo)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteFrance
- Study dates
- May 2014to Mar 2015
- Phase
- Phase 3
- 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 50 to 85 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a urinary retention due to obstructive benign prostatic hyperplasia (BPH) confirmed by endoscopy,
- Patients aged 50-85 years,
- Patients with indwelling urinary catheter for at least 1 month,
- Patients with at least one failure of a trial without catheter despite alpha-blocker treatment for at least 72 hours,
- Patients informed about alternative treatment (transurethral resection of the prostate, laser prostatectomy, prostatic adenomectomy),
- Patients signed an informed consent form.
Who cannot join
- Prostate cancer (evaluated by PSA, physical examination, in all patients and by prostatic biopsy in suspicious cases).
- History of relevant neurological disease (e.g. multiple sclerosis, spinal cord injury, parkinson's disease).
- Patients who have on urodynamic investigation evidence of an atonic bladder.
- Urethral stricture
- Chronic persistent local pathology that may cause urinary symptoms (e.g. interstitial cystitis, tumor, bladder stone).
- Renal insufficiency stade 3 or 4 (creatinine clearance < 35 mL/min)
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- Any allergy or contraindication to ciprofloxacin or drugs used in this protocole (xylocaine, Atarax, paracetamol, and nonsteroidal anti-inflammatory drug)
- Any allergy to intravenous contrast agent or iodine
- Thyrotoxicosis
- Concomitant use of tizanidine
- Patients participating to another research protocol
Trial locations and contacts
1 site in 1 country.
About this study
Background: Patients with indwelling urinary catheter for chronic retention due to obstructive BPH refractory to medical therapy are candidates for prostatectomy still considered as the gold standard of treatment. Urinary tract infection, strictures, postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss are complications associated with surgery. Minimally invasive treatments were originally conceived as an attempt to offer equivalent efficacy without the burden and risk of operative morbidity. Recently, it was suggested that prostatic arterial embolization (PAE) to treat BPH might follow uterine artery embolization for uterine leiomyomas. Animal studies in pigs and dogs have shown that PAE is safe and can induce prostatic volume reduction. The first report of this technique in the management of BPH in humans was by DeMeritt et al, who reported a single case of BPH with obstructive symptoms and blood loss refractory to other treatments that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.
Objective : We investigate whether PAE might be a feasible procedure as an alternative treatment option to treat urinary retention due to obstructive BPH. The primary objective is to evaluate the success rate of procedure defined when selective prostatic arterial catheterization and embolization were achieve and patients can be able to urinate after their urinary catheter has been removed.
Read more
Patients and methods : A monocentric prospective study is undertaken in 25 patients aged 50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory to medical treatment with a clinical indication for surgery who agreed to undergo PAE. The study is approved by the hospital ethical committee and an informed consent form for PAE as an alternative treatment is signed by all participants.
Statistical analysis : The sample size has been calculated in order to have an estimated probability of success (corresponding of primary objective) of 50% (worst case) with 95% confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally, the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is indicative of statistically significant.
Read the detailed description
Embolization is performed under local anesthesia in one day surgery unit by unilateral approach, usually the right femoral artery. Initially, pelvic angiography is performed to evaluate the iliac and prostatic arteries. Then, a 5-F catheter is introduced in right femoral artery to catheterize the left hypogastric artery and reach its anterior division. The inferior vesical artery and finally the prostatic vessels are selectively catheterized with a 3-F coaxial microcatheter. For embolization, nonspherical 100-300 μm PVA particles is used. The endpoint chosen for embolization is slow flow or near-stasis in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification. When embolization of the left prostatic arteries was finished, the right prostatic arteries were embolized in the same way.
Urinary catheter is removed 10 days after the embolization procedure. Voiding trials is performed and the successfull urination after urethral catheter removal is defined as three consecutive spontaneous micturitions with postvoid residual less than 100% of each micturition volume. If the patient is unable to urinate, a urethral catheter will replace before hospitalization discharge and the patient will return to our outpatient clinic for another voiding trial until the end of protocol. Assessments were carried out 10, 30 and 90 days after initial embolization allocation.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Prostatic arterial embolization using BeadBlock (Terumo)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostatic arterial embolization using BeadBlock (Terumo)Device
Selective Prostatic arterial embolization using BeadBlock (Terumo)particuls
| Study group | Role | What they receive |
|---|---|---|
| Embolization procedure | Experimental | selective prostatic arterial embolization using BeadBlock (Terumo) particules Receives: Device: Prostatic arterial embolization using BeadBlock (Terumo) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success
- Procedural success was defined as cessation of extravasation and/or occlusion of the targeted vessel on postembolization arteriography.
- Voiding diary : mictirution volume and postvoid residual volume measurements by ultrasonography
Measured: Day 1
Secondary outcomes (3)
success of the procedure : ability to urinate after their catheter
Ablation of Indwelling Urinary Catheter
Measured: Day 10
success of the procedure : ability to urinate after their catheter
Ablation of Indwelling Urinary Catheter
Measured: Day 90
success of the procedure : ability to urinate after their catheter
Ablation of Indwelling Urinary Catheter
Measured: Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2013 (estimated)
- Study startMay 2014
- Primary completionMar 2015
- Study completionMar 2015
Why it stopped: Enrolling participants has halted prematurely and will not resume due to the Departure of the principal investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostatic HyperplasiaStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Romain CAREMEL, MD, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01931605
- Sponsor's protocol ID
- 2012/173/HP
- Acronym
- Prost-EMBOL
- Status last verified
- Jul 2015
- First submitted
- 4 Jul 2013
- Last updated
- 30 Jul 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Selective Prostatic Arterial Embolization in Patients With Indwelling Urinary Catheter Due to Benign Prostatic Hyperplasia Refractory to Medical Treatment.
- ClinicalTrials.gov ID
- NCT01931605
- Acronym / sponsor ID
- Prost-EMBOL / 2012/173/HP
- Conditions
- Benign Prostatic Hyperplasia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrolling participants has halted prematurely and will not resume due to the Departure of the principal investigator
- Enrolment
- 2 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- May 2014
- Primary completion
- Mar 2015 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 29 Aug 2013 (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.
Background: Patients with indwelling urinary catheter for chronic retention due to obstructive BPH refractory to medical therapy are candidates for prostatectomy still considered as the gold standard of treatment. Urinary tract infection, strictures, postoperative pain, incontinence, sexual dysfunction, anesthesiologist risk and blood loss are complications associated with surgery. Minimally invasive treatments were originally conceived as an attempt to offer equivalent efficacy without the burden and risk of operative morbidity. Recently, it was suggested that prostatic arterial embolization (PAE) to treat BPH might follow uterine artery embolization for uterine leiomyomas. Animal studies in pigs and dogs have shown that PAE is safe and can induce prostatic volume reduction. The first report of this technique in the management of BPH in humans was by DeMeritt et al, who reported a single case of BPH with obstructive symptoms and blood loss refractory to other treatments that was successfully managed by PAE with polyvinyl alcohol (PVA) particles.
Objective : We investigate whether PAE might be a feasible procedure as an alternative treatment option to treat urinary retention due to obstructive BPH. The primary objective is to evaluate the success rate of procedure defined when selective prostatic arterial catheterization and embolization were achieve and patients can be able to urinate after their urinary catheter has been removed.
Patients and methods : A monocentric prospective study is undertaken in 25 patients aged 50-85 years who present with indwelling urinary catheter due to obstructive BPH refractory to medical treatment with a clinical indication for surgery who agreed to undergo PAE. The study is approved by the hospital ethical committee and an informed consent form for PAE as an alternative treatment is signed by all participants.
Statistical analysis : The sample size has been calculated in order to have an estimated probability of success (corresponding of primary objective) of 50% (worst case) with 95% confidence intervals of 30 to 70. The two-sample t-test (and Wilcoxon rank-sum test) is used to compare the mean changes of the variables from baseline to 10, 30 and 90 days. Finally, the Chi-square test is used to test for adverse events at the end of follow-up. P ≤ 0.05 is indicative of statistically significant.
Detailed description
Embolization is performed under local anesthesia in one day surgery unit by unilateral approach, usually the right femoral artery. Initially, pelvic angiography is performed to evaluate the iliac and prostatic arteries. Then, a 5-F catheter is introduced in right femoral artery to catheterize the left hypogastric artery and reach its anterior division. The inferior vesical artery and finally the prostatic vessels are selectively catheterized with a 3-F coaxial microcatheter. For embolization, nonspherical 100-300 μm PVA particles is used. The endpoint chosen for embolization is slow flow or near-stasis in the prostatic vessels with interruption of the arterial flow and prostatic gland opacification. When embolization of the left prostatic arteries was finished, the right prostatic arteries were embolized in the same way.
Urinary catheter is removed 10 days after the embolization procedure. Voiding trials is performed and the successfull urination after urethral catheter removal is defined as three consecutive spontaneous micturitions with postvoid residual less than 100% of each micturition volume. If the patient is unable to urinate, a urethral catheter will replace before hospitalization discharge and the patient will return to our outpatient clinic for another voiding trial until the end of protocol. Assessments were carried out 10, 30 and 90 days after initial embolization allocation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Embolization procedure | Experimental | Device: Prostatic arterial embolization using BeadBlock (Terumo)selective prostatic arterial embolization using BeadBlock (Terumo) particules |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with a urinary retention due to obstructive benign prostatic hyperplasia (BPH) confirmed by endoscopy,
- Patients aged 50-85 years,
- Patients with indwelling urinary catheter for at least 1 month,
- Patients with at least one failure of a trial without catheter despite alpha-blocker treatment for at least 72 hours,
- Patients informed about alternative treatment (transurethral resection of the prostate, laser prostatectomy, prostatic adenomectomy),
Key exclusion criteria (11 listed)
- Prostate cancer (evaluated by PSA, physical examination, in all patients and by prostatic biopsy in suspicious cases).
- History of relevant neurological disease (e.g. multiple sclerosis, spinal cord injury, parkinson's disease).
- Patients who have on urodynamic investigation evidence of an atonic bladder.
- Urethral stricture
- Chronic persistent local pathology that may cause urinary symptoms (e.g. interstitial cystitis, tumor, bladder stone).
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 |
|---|---|---|
| Prostatic arterial embolization using BeadBlock (Terumo)Selective Prostatic arterial embolization using BeadBlock (Terumo)particuls | Device | Embolization procedure |
Primary outcome
Procedural Success
Time frame: Day 1
* Procedural success was defined as cessation of extravasation and/or occlusion of the targeted vessel on postembolization arteriography. * Voiding diary : mictirution volume and postvoid residual volume measurements by ultrasonography
3 secondary outcomes
success of the procedure : ability to urinate after their catheter
Time frame: Day 10
success of the procedure : ability to urinate after their catheter
Time frame: Day 90
success of the procedure : ability to urinate after their catheter
Time frame: Day 30
Results and safety
The study was stopped early (reason given: Enrolling participants has halted prematurely and will not resume due to the Departure of the principal investigator). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2015.
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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.
Romain CAREMEL, MD principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Prostatic arterial embolization using BeadBlock (Terumo) in people with Benign Prostatic Hyperplasia, run by University Hospital, Rouen 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 6 inclusion and 11 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: stopped early, as of the sponsor's last update on 30 Jul 2015. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Enrolling participants has halted prematurely and will not resume due to the Departure of the principal investigator). 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?
Procedural Success (time frame: Day 1). 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 30 Jul 2015.