Benign Prostate HyperplasiaNCT02822924
Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia
A study testing Prostate artery embolization (PAE) in people with Benign Prostate Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
Trial summary
The objective is to evaluate the clinical effectiveness and safety of PAE in treating patients with BPH. Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostate Hyperplasia
- What is being tested?
- Prostate artery embolization (PAE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteHong Kong
- Study dates
- 7 Oct 2013to 10 Mar 2021
- 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 50 to 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 50 and 80 years old.
- Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, despite medical treatment with alpha-blockers for at least 6 months, or
- Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, for whom medication is contraindicated, not tolerated or refused, or
- Patients with history of acute retention of urine with or without previous treatment with Alpha-blockers.
- Patients with QOL score ≥3.
- Patients with Urine flow rate < 15ml/second or acute urinary retention.
- Patients with evidence of prostatic enlargement determined by digital rectal examination or ultrasonography (USG), with a prostate size of not less than 40 grams.
Who cannot join
- Active urinary tract infection
- Biopsy proven prostate or bladder cancer, or any recent cancer within 5 years other than basal or squamous cell skin cancer
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- Prostate size <40 grams on CT or MRI
- Previous non-medical BPH treatment, including surgery, TURP, needle ablation, microwave or laser therapy, balloon dilation, stent implantation, or any other invasive treatment to the prostate
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- Any known condition that limits catheter-based intervention or is a contraindication to embolization, such as intolerance to a vessel occlusion procedure or severe atherosclerosis.
- Unable to have MRI imaging (e.g. metal implant including pacemaker, replacement joint, etc)
- Cardiac condition including congestive heart failure or arrhythmia, uncontrolled diabetes mellitus, significant respiratory disease or known immunosuppression which required hospitalization within the previous 6 months
- Baseline serum creatinine level > 160 umol/L
- Known upper tract renal disease
- Cystolithiasis or chronic hematuria within 3 months prior to study treatment
- Active prostatitis
- Previous rectal surgery other than hemorrhoidectomy, or history of rectal disease
- History of pelvic irradiation or radical pelvic surgery
- Coagulation disturbances not normalized by medical treatment
- Known major iliac arterial occlusive disease
- Allergy to iodinated contrast agents
- Hypersensitivity to gelatin products
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Department of Imaging and Interventional Radiology, Prince of Wales Hospital, The Chinese University of Hong Kong
Hong Kong
About this study
The objective is to evaluate the clinical effectiveness and safety of PAE in treating patients with BPH.
Read the detailed description
Benign prostatic hyperplasia (BPH), non-malignant enlargement of the prostate, is a common condition among elderly men with a prevalence increasing with age. When sufficiently large, the hyperplastic nodules compress the urethral canal to cause obstruction of the urethra and interfere the normal flow of urine, leading to symptoms of urinary hesitancy, frequent urination, increased risk of urinary tract infections and urinary retention. While medication is often prescribed as the first treatment option, it often does not adequately restore normal urine flow. Many patients being treated with medication may not achieve sustained improvement in symptoms, or they may stop taking the medication because of side effects, therefore other forms of treatments may be necessary. Although surgery with transurethral resection of prostate (TURP) is a benchmark for BPH treatment, it involves insertion of an endoscope is inserted through the penis, and removal of the prostate piece by piece. While considered a safe technique with a mortality rate below 0.25%, it is not without adverse events. The most frequent complications are ejaculatory disorders (up to 80%), early urinary incontinence (30 to 40%), acute urinary retention caused by blood clots (2 to 5%), sexual impotence (up to 5%), and the need for blood transfusions (0.4 to 7%). Patients who have undergone TURP require surgical retreatment for lower urinary tract symptoms in 3 to 14.5% of cases. Others include infection and urethral stricture. Therefore TURP is only recommended for complicated or severe BPH due to its adverse effects. Prostatic artery embolization (PAE) is a potentially promising, minimally invasive alternative procedure for BPH. Results from early studies showed that PAE might be a safe and effective treatment for BPH.
- Conditions
- Benign Prostate Hyperplasia
- Being tested
- Prostate artery embolization (PAE)
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prostate artery embolization (PAE)Procedure or surgery
Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries.
| Study group | Role | What they receive |
|---|---|---|
| Prostate artery embolization treatment | Other | Prostatic artery embolization (PAE) as a new treatment technology is a potentially promising, minimally invasive alternative procedure for BPH, which has been shown to be safe and effective in both animal models and clinical trials. Receives: Procedure: Prostate artery embolization (PAE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
successful procedure
Procedure success defined as technically successful selective prostatic arterial catheterization and embolization
Measured: within 1 hour after PAE procedure
Secondary outcomes (1)
Incidence of procedure related complication
Complication after treatment procedure will be recorded. Major adverse events, which included ischemic, infectious, or puncture site complications, pain will be recorded and evaluated. Further imaging or laboratory studies are conducted when a complication was suspected.
Measured: 6-8 hours after treatment until 1 month time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2016 (estimated)
- Study start7 Oct 2013
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Benign Prostate HyperplasiaStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Yu, Chinese University of Hong Kong
- Investigators
- Simon Yu, Profesor, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02822924
- Sponsor's protocol ID
- VIR-13-05
- Status last verified
- Oct 2022
- First submitted
- 28 Jun 2016
- Last updated
- 21 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prostate Artery Embolization for Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT02822924
- Acronym / sponsor ID
- VIR-13-05
- Conditions
- Benign Prostate Hyperplasia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 7 Oct 2013 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 6 Jul 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 objective is to evaluate the clinical effectiveness and safety of PAE in treating patients with BPH.
Detailed description
Benign prostatic hyperplasia (BPH), non-malignant enlargement of the prostate, is a common condition among elderly men with a prevalence increasing with age. When sufficiently large, the hyperplastic nodules compress the urethral canal to cause obstruction of the urethra and interfere the normal flow of urine, leading to symptoms of urinary hesitancy, frequent urination, increased risk of urinary tract infections and urinary retention. While medication is often prescribed as the first treatment option, it often does not adequately restore normal urine flow. Many patients being treated with medication may not achieve sustained improvement in symptoms, or they may stop taking the medication because of side effects, therefore other forms of treatments may be necessary. Although surgery with transurethral resection of prostate (TURP) is a benchmark for BPH treatment, it involves insertion of an endoscope is inserted through the penis, and removal of the prostate piece by piece. While considered a safe technique with a mortality rate below 0.25%, it is not without adverse events. The most frequent complications are ejaculatory disorders (up to 80%), early urinary incontinence (30 to 40%), acute urinary retention caused by blood clots (2 to 5%), sexual impotence (up to 5%), and the need for blood transfusions (0.4 to 7%). Patients who have undergone TURP require surgical retreatment for lower urinary tract symptoms in 3 to 14.5% of cases. Others include infection and urethral stricture. Therefore TURP is only recommended for complicated or severe BPH due to its adverse effects. Prostatic artery embolization (PAE) is a potentially promising, minimally invasive alternative procedure for BPH. Results from early studies showed that PAE might be a safe and effective treatment for BPH.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate artery embolization treatment | Other | Procedure: Prostate artery embolization (PAE)Prostatic artery embolization (PAE) as a new treatment technology is a potentially promising, minimally invasive alternative procedure for BPH, which has been shown to be safe and effective in both animal models and clinical trials. |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age between 50 and 80 years old.
- Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, despite medical treatment with alpha-blockers for at least 6 months, or
- Suffered from lower urinary tract symptoms with International Prostate Symptom Score (IPSS) ≥13, for whom medication is contraindicated, not tolerated or refused, or
- Patients with history of acute retention of urine with or without previous treatment with Alpha-blockers.
- Patients with QOL score ≥3.
Key exclusion criteria (19 listed)
- Active urinary tract infection
- Biopsy proven prostate or bladder cancer, or any recent cancer within 5 years other than basal or squamous cell skin cancer
- Bladder atonia, neurogenic bladder disorder or other neurological disorder that is impacting bladder function (e.g. multiple sclerosis, Parkinson's disease, spinal cord injuries, etc)
- Urethral stricture, bladder neck contracture, sphincter abnormalities, urinary obstruction due to causes other than BPH, or other potentially confounding bladder or urethral disease or condition
- Prostate size <40 grams on CT or MRI
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 |
|---|---|---|
| Prostate artery embolization (PAE)Right femoral arterial puncture is performed under local anesthesia. The blood supply to the prostate is mapped by angiography of the iliac vessels and the prostate arteries. Microcatheters are used for super-selective catheterization of the right and left inferior vesicle arteries. Embolization is performed with a microcatheter to deliver microspheres of 300 micron diameter. The microsphere mixture is slowly injected under fluoroscopic guidance. The endpoint of embolization is flow stasis in the prostatic vessels with prostatic gland opacification, without reflux of the mixture to undesired arteries. | Procedure or surgery | Prostate artery embolization treatment |
Primary outcome
successful procedure
Time frame: within 1 hour after PAE procedure
Procedure success defined as technically successful selective prostatic arterial catheterization and embolization
1 secondary outcome
Incidence of procedure related complication
Time frame: 6-8 hours after treatment until 1 month time
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 21 Oct 2022.
- Individual participant dataSharing planned: No
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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.
Simon Yu, Profesor principal investigator
Chinese University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prostate artery embolization (PAE) in people with Benign Prostate Hyperplasia, run by Chinese University of Hong Kong at 1 site in Hong Kong.
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 7 inclusion and 19 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 21 Oct 2022. 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 Hong Kong. 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?
successful procedure (time frame: within 1 hour after PAE procedure). 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 Oct 2022.