Lower Urinary Tract SymptomNCT03239652
Taiwan ACE Beads for Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
A study testing Taiwan ACE Beads in people with Lower Urinary Tract Symptom and Benign Prostatic Hyperplasia (BPH), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
Trial summary
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptom, Benign Prostatic Hyperplasia (BPH)
- What is being tested?
- Taiwan ACE Beads
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2017to 30 Jun 2020
- 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 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.
- Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS.
- Prostate volume > 50 mL.
- Urinary flow rate <15 mL / sec.
- Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate.
Who cannot join
- If patients meet any of the following criteria they may not be entered into the study:
- Major pelvic disease, or other malignancies.
- Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL).
- Had Prostate surgery.
- Chronic bacterial prostatitis.
- Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.
Show all 25Show fewer
- Main organs (heart, lung, liver, kidney) dysfunction who are not eligible for clinical trials under physicians' consideration.
- White Blood Cell< 2000 or Severe thrombocytopenia（Platelet count <50,000/μL)，or blood coagulation abnormalities uncorrectable .
- Unable to follow-up by MRI 3 times.
- Unable to follow-up by ultrasound or CT scan.
- Unwilling to sign a written informed consent form.
- Allergic to Iodine or other injections.
- Acute bacterial prostatitis.
- Patients with active urinary tract infections or recurrent urinary tract infections (>2/years), prostatitis, or interstitial cystitis.
- Cases of biopsy proven prostate, bladder, or urethral cancer.
- Patients with glomerular filtration rates less than 40 who are not already on dialysis.
- Patients with bilateral internal iliac arterial occlusion.
- Patients with causes of bladder obstruction not due to BPH (eg urethral stricture, bladder neck contraction, etc).
- Patients with neurogenic or bladder atonia.
- Patients where embolization is not possible distal to collateral vessels feeding non-prostatic tissue.
- Patients with major neurologic illnesses which could have symptoms that may be similar to or confused for BPH (eg multiple sclerosis, Shy-Drager syndrome, spinal cord injury, etc.).
- Patients with urethral stents.
- Other than hemorrhoidectomy or pelvic irradiation, patients who have undergone prior rectal surgery.
- Patients who have started or changed their dosage of alpha blockers or 5-alpha reductase inhibitors in the month prior to prostatic artery embolization.
- Allergic to pharmaceutical excipients related to Microspheres.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
National Cheng Kung University Hospital
Tainan
Xi-Zhang Lin, MD, 886-6-2353535 ext. 3624, linxz@mail.ncku.edu.tw
Hui-Yu Hung, Bachelor, 886-6-2353535 ext. 3624, z9908033@email.ncku.edu.tw
About this study
Official title: Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).
Read the detailed description
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial, we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic hyperplasia patients, which is beneficial to the participants in precise medicine as well as in the pharmaceutical and medical device industry.
- Being tested
- Taiwan ACE Beads
- Keywords
- Microsphere, Transcatheter Arterial chemo-embolization
- Medical subject headings
- Lower Urinary Tract Symptoms, Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Taiwan ACE BeadsDevice
Similar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol.
| Study group | Role | What they receive |
|---|---|---|
| Taiwan ACE Beads microspheres | Experimental | The maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour. Receives: Device: Taiwan ACE Beads |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Survival (Safety)
Survival rate was evaluated since treatment day until the date of death or final observation.
Measured: An average of 12 weeks.
Secondary outcomes (3)
Change on Patient's Symptoms
Change on patients' International Prostate Symptom Score (IPSS)
Measured: Before treatment, one and three months after treatment
Change on Prostate Volume
Prostate volume measured using MRI
Measured: Before treatment, one and three months after treatment.
Change in serum Prostate Specific Antigen (PSA) concentration
Measurement of Prostate Specific Antigen in patients undergoing this treatment.
Measured: Before treatment, one and three months after treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2017
- Study start1 Jan 2017
- Primary completion30 Jun 2020 (estimated)
- Study completion30 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lower Urinary Tract SymptomStudies 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cheng-Kung University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan
- Responsible party
- Sponsor
- Investigators
- Yuh-Shyan Tsai, MD, Principal investigator, Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03239652
- Sponsor's protocol ID
- A-BR-105-055
- Status last verified
- Aug 2019
- First submitted
- 25 Jul 2017
- Last updated
- 17 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
PubMed 26339465Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.
PubMed 27146488
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Prostatic Artery Embolization Therapy in Symptomatic Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT03239652
- Acronym / sponsor ID
- A-BR-105-055
- Keywords
- Microsphere, Transcatheter Arterial chemo-embolization
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- National Cheng-Kung University HospitalUniversity, hospital or other
- Collaborators
- The Industrial Technology Research Institute, National Cheng Kung University, National Research Program for Biopharmaceuticals, Taiwan
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 30 Jun 2020 (estimated)
- First posted
- 4 Aug 2017 (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.
In this proposal, the investigators plan to conduct a clinical trial to validate the efficacy and safety of microspheres (T-ACE Beads).
Detailed description
T-ACE Beads can be used for prostatic arterial embolization safely and efficiently. Furthermore, investigator's microspheres has advantageous characteristics in biodegradability, drug delivery capability, and cost-effectiveness. After the clinical trial, we anticipate introducing a new microsphere for Lower Urinary Tract Symptom/Benign prostatic hyperplasia patients, which is beneficial to the participants in precise medicine as well as in the pharmaceutical and medical device industry.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Taiwan ACE Beads microspheres | Experimental | Device: Taiwan ACE BeadsThe maximum use of dosage will not exceed 100 milligrams. The embolization procedure usually lasts less than an hour. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Men ≥ 50 years of age. Healthy patients or volunteers without diagnosis of Lower urinary tract symptoms (LUTS) / Benign prostatic hyperplasia (BPH) will not be included.
- Patients diagnosed of LUTS / BPH，International Prostate Symptom Score > 12 with mild to severe symptom of LUTS.
- Prostate volume > 50 mL.
- Urinary flow rate <15 mL / sec.
- Ineffectiveness after 6 months of previous medical treatment, or the side effects are too difficult to tolerate.
Key exclusion criteria (25 listed)
- Major pelvic disease, or other malignancies.
- Prostate specific antigen of serum > 10 ng/mL, malignant tumor not yet rule out (prostate specific antigen PSA>10 ng/mL).
- Had Prostate surgery.
- Chronic bacterial prostatitis.
- Renal dysfunction or bladder diverticulum stones caused by prostate disease obstruction.
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 |
|---|---|---|
| Taiwan ACE BeadsSimilar with conventional Transcatheter Arterial chemo-embolization, radiologist use Taiwan ACE Beads instead of Gelfoam or polyvinyl alcohol. | Device | Taiwan ACE Beads microspheres |
Primary outcome
Patients Survival (Safety)
Time frame: An average of 12 weeks.
Survival rate was evaluated since treatment day until the date of death or final observation.
3 secondary outcomes
Change on Patient's Symptoms
Time frame: Before treatment, one and three months after treatment
Change on Prostate Volume
Time frame: Before treatment, one and three months after treatment.
Change in serum Prostate Specific Antigen (PSA) concentration
Time frame: Before treatment, one and three months after treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2019.
- Results publication: PubMed 26339465Liu YS, Lin XZ, Tsai HM, Tsai HW, Chen GC, Chen SF, Kang JW, Chou CM, Chen CY. Development of biodegradable radiopaque microsphere for arterial embolization-a pig study. World J Radiol. 2015 Aug 28;7(8):212-9. doi: 10.4329/wjr.v7.i8.212.
- Results publication: PubMed 27146488Noor A, Fischman AM. Prostate Artery Embolization as a New Treatment for Benign Prostate Hyperplasia: Contemporary Status in 2016. Curr Urol Rep. 2016 Jul;17(7):51. doi: 10.1007/s11934-016-0608-0.
- Individual participant dataSharing planned: No
Related trials for Lower Urinary Tract Symptom
RecruitingPhase 2
A Proof-Of-Concept (POC) Study of SFG-02 Transdermal Formulation in Participants With Underactive Bladder (UAB)
Participants With Underactive Bladder (UAB)
Not yet recruiting
Radiofrequency and Pelvic Floor-Core Exercise for Chronic Low Back Pain in Women With Pelvic Floor Dysfunction
Chronic Low Back Pain, Urinary Incontinence
Active, not recruitingPhase 1/2
RT-310 Safety and Feasibility BPH Study
BPH (Benign Prostatic Hyperplasia)
RecruitingObservational study
Standardized 4D Transperineal Ultrasound Assessment of Urethrovesical Junction Mobility After Vaginal Laser Treatment for Stress Urinary Incontinence.
Urinary Incontinence , Stress, Laser Therapy
Not yet recruiting
Feasibility of Resisted Expiratory Muscle Training for Females Assigned at Birth With Stress Urinary Incontinence: A Pilot Study
Stress Urinary Incontinence
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.
Yuh-Shyan Tsai, MD principal investigator
Department of Urology, National Cheng Kung University Hospital, College of medicine, National Cheng Kung University, Tainan 70403, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Taiwan ACE Beads in people with Lower Urinary Tract Symptom and Benign Prostatic Hyperplasia (BPH), run by National Cheng-Kung University Hospital at 1 site in Taiwan.
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 5 inclusion and 25 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 17 Oct 2019. 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 Taiwan. 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?
Contact Xi-Zhang Lin, MD (886-6-2353535 ext. 6202/3624, linxz@mail.ncku.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients Survival (Safety) (time frame: An average of 12 weeks.). 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 NCT03239652, which also lists 2 linked publications.
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 17 Oct 2019.