Benign Prostatic HyperplasiaPhase 2/3NCT05531344
Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia
A Phase 2/3 study testing Composite Steep-pulse Treatment Device and Tamsulosin Hydrochloride Capsules in people with Benign Prostatic Hyperplasia, run by REMD Medical Technology at 1 site in China.
Trial summary
This is a prospective, randomized, open-label, parallel-group, medication-control, superiority, multicenter clinical study trial. This study is studying the effects and safety in treating patients from nine different centers with Benign prostatic hyperplasia, employing Composite Steep-pulse(High-frequency irreversible… Read more about this study
- Who is it for?
- Ages 50 to 80 years, men only
- Conditions the study is for
- Benign Prostatic Hyperplasia
- What is being tested?
- Composite Steep-pulse Treatment Device and Tamsulosin Hydrochloride Capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 1 siteChina
- Study dates
- 20 Aug 2020to 8 Jul 2022
- Phase
- Phase 2/3
- 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 80 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males between 50 to 80 years old;
- Patients who Fully understand the treatment plan for irreversible electroporation, and accept the trial treatment and signed informed consent form;
- International Prostate Symptom Score (IPSS)≥12;
- Patients who have no willing to perform enucleation or transurethral resection of prostate;
- Maximum urinary flow rate (Qmax) >5ml/min and ≤15ml/min, voided volume ≥150ml;
- The volume of prostate was ≥30cm3 measured by MRI;
- Patients who Could perform follow-up evaluation in accordance with the trial protocol.
Who cannot join
- Patients with a history of prostate cancer, or who confirmed diagnosis of prostate cancer (needle biopsy of the prostate is required for patients indicated for needle aspiration, and if the needle result suggests benign prostatic hyperplasia, enrollment is allowed);
- Patients with second-degree or higher atrioventricular block and other cardiac diseases with clear contraindications to anesthesia;
- Patients with cardiac pacemakers and metallic replacement of pelvis or hip joints;
- Patients who underwent previous prostate surgery for benign prostatic hyperplasia;
- patients who have history of soft or rigid cystoscopy or other transurethral device use within 7 days prior to Informed Consent Form signed;
- Any condition other than BPH that could lead to urinary symptoms or altered urinary flow rate (such as neurogenic bladder, bladder neck contracture, urethral stricture, bladder malignancy, acute or chronic prostatitis, acute or chronic urinary tract infection) as judged by the investigator;
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- Patients with a previous history of epilepsy;
- Patients who have participated in other clinical trials within 3 months.
- Patients with ASA (American Society of Anesthesiology) score 4 or above, such as malignant hypertension, recent myocardial infarction, active cerebrovascular accident, severe anemia and other contraindications to general anesthesia;
- Patients who are considered to be inappropriate for participation in the trial by the investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Device Used in Patients With Benign Prostatic Hyperplasia
This is a prospective, randomized, open-label, parallel-group, medication-control, superiority, multicenter clinical study trial.
This study is studying the effects and safety in treating patients from nine different centers with Benign prostatic hyperplasia, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of hyperplasia tissue cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and urodynamic data analysis of each patient will be evaluated in each study patients.
Read the detailed description
Background:
Benign prostatic hyperplasia (BPH) is a frequently-occurring disease in elderly males. The incidence of BPH is as high as 50% in males over 50 years old, while the incidence of BPH is as high as 80% in males over 80 years old.
Current treatments for benign prostatic hyperplasia include oral drug therapy and surgical treatment. Drug therapy mainly includes:1. 5-α reductase inhibitors, such as Finasteride, which can delay or reduce the prostate volume, but it is required for 3-6 months to take effect, and patients need prolonged maintenance therapy. And it is contraindicated in patients with abnormal liver function, because the drug needs to be metabolized by the liver; 2. α receptor blockers, such as Tamsulosin and Doxazosin, which are able to relax the bladder neck, prostate and urethral smooth muscle, thereby reducing prostatic urethral resistance. It cannot reduce the size of the prostate gland, so it cannot fundamentally prevent the development of benign prostatic hyperplasia, while the effect on large volume benign prostatic hyperplasia is not obvious, and it is contraindicated in patients with renal insufficiency; 3 Traditional medicines, which can only be used as a supplementary drug.
Surgery is the second-line treatment of BPH, and its standard procedure is transurethral resection of the prostate (TURP), which is considered to be the gold standard surgical procedure due to its exact efficacy and minimally invasive nature. However, large-scale retrospective studies have shown severe complications after TURP, especially TURP syndrome, postoperative urinary incontinence, urethral stricture, etc., hence there are still many concerns about the application of this procedure. Although plasma transurethral resection of the prostate and various laser prostate surgeries have sprung up in recent years, the basic surgical operation concept is not changed and the common problems existing in the procedure cannot be completely avoided. Luckily, with the development of technology, more and more new and effective treatments have emerged for BPH.
In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading to necrosis of tumor or diseased cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device in the treatment of BPH.
- This study will assess the safety of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device in the treatment of BPH.
Methods:
- patients recruitment
- Irreversible Electroporation of malignant diseased Cell under Composite Steep-pulse Treatment for the patients with Benign Prostatic Hyperplasia;
- Some factors such as prostate MRI, IPSS score, Qmax will be performed to evaluate the efficacy of the treatment.
- Other factors such as the routine blood test, the routine urine test, the blood biochemistry test, ect. will be performed to evaluate the safety of the treatment.
- Conditions
- Benign Prostatic Hyperplasia
- Being tested
- Composite Steep-pulse Treatment Device, Tamsulosin Hydrochloride Capsules
- Keywords
- IRE, Composite Steep-pulse Treatment Device, Benign Prostatic Hyperplasia, randomized, medication-control, superiority, multi-center
- Medical subject headings
- Prostatic Hyperplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Composite Steep-pulse Treatment DeviceDevice
Applying the Composite Steep-pulse Treatment Device to treat the patients with Benign Prostatic Hyperplasia
Tamsulosin Hydrochloride CapsulesDrug
Applying Tamsulosin Hydrochloride Capsules to treat the patients with Benign Prostatic Hyperplasia
| Study group | Role | What they receive |
|---|---|---|
| Composite Steep-pulse Treatment Device | Experimental | Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device Receives: Device: Composite Steep-pulse Treatment Device |
| Tamsulosin | Active comparator | Tamsulosin Hydrochloride Sustained Release Capsules, 0.2mg, once a day,3 months Receives: Drug: Tamsulosin Hydrochloride Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference value in urinary Qmax between 3 months after treatment with baseline.
The Qmax was measured before treatment, 1 month and 3 months after treatment,and baseline difference values (posttreatment-Pretreatment) were calculated. The difference value of Qmax at 3 months after treatment with baseline was used as the primary outcome.
Measured: 0,3 months
Secondary outcomes (4)
Difference value of size of prostate between different visits
Before and 3 months after treatment, prostate size was measured by prostate magnetic resonance scanning, and the rate of change was calculated.
Measured: 0,3 months
Difference value of Qmax between different visits
Qmax was measured before treatment, 1 month and 3 months after treatment.
Measured: 0,1,3 months
Difference value of IPSS score between different visits
Before treatment, 1 month and 3 months after treatment, the prostate function of the subjects was calculated according to the International Prostate Symptom Score (I PSS), and the total score and improvement score were counted, respectively.
Measured: 0,1,3 months
Operability of host system of device
Evaluate the operability of the host system of device after surgery: satisfied, commonly, dissatisfied
Measured: The day of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2022
- Study start20 Aug 2020
- Primary completion8 Jul 2022
- Study completion8 Jul 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 Benign Prostatic HyperplasiaStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- REMD Medical Technology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- RenJi Hospital, Dongfang Hospital Affiliated to Tongji University, Shanghai Pudong Hospital, Qilu Hospital of Shandong University, Ningbo No.2 Hospital, Shangdong Yiyuan Hospital, Tongji Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Provincial People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05531344
- Sponsor's protocol ID
- REMD02
- Status last verified
- Aug 2022
- First submitted
- 3 Sep 2022
- Last updated
- 7 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.
PubMed 18082216
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Device Used in Patients With Benign Prostatic Hyperplasia
- ClinicalTrials.gov ID
- NCT05531344
- Acronym / sponsor ID
- REMD02
- Conditions
- Benign Prostatic Hyperplasia
- Keywords
- IRE, Composite Steep-pulse Treatment Device, Benign Prostatic Hyperplasia, randomized, medication-control, superiority, multi-center
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- REMD Medical TechnologyIndustry (pharma, biotech, devices)
- Collaborators
- RenJi Hospital, Dongfang Hospital Affiliated to Tongji University, Shanghai Pudong Hospital, Qilu Hospital of Shandong University, Ningbo No.2 Hospital, Shangdong Yiyuan Hospital, Tongji Hospital, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Hunan Provincial People's Hospital
- Study start
- 20 Aug 2020 (actual)
- Primary completion
- 8 Jul 2022 (actual)
- Study completion
- 8 Jul 2022 (actual)
- First posted
- 7 Sep 2022 (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.
This is a prospective, randomized, open-label, parallel-group, medication-control, superiority, multicenter clinical study trial.
This study is studying the effects and safety in treating patients from nine different centers with Benign prostatic hyperplasia, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of hyperplasia tissue cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and urodynamic data analysis of each patient will be evaluated in each study patients.
Detailed description
Background:
Benign prostatic hyperplasia (BPH) is a frequently-occurring disease in elderly males. The incidence of BPH is as high as 50% in males over 50 years old, while the incidence of BPH is as high as 80% in males over 80 years old.
Current treatments for benign prostatic hyperplasia include oral drug therapy and surgical treatment. Drug therapy mainly includes:1. 5-α reductase inhibitors, such as Finasteride, which can delay or reduce the prostate volume, but it is required for 3-6 months to take effect, and patients need prolonged maintenance therapy. And it is contraindicated in patients with abnormal liver function, because the drug needs to be metabolized by the liver; 2. α receptor blockers, such as Tamsulosin and Doxazosin, which are able to relax the bladder neck, prostate and urethral smooth muscle, thereby reducing prostatic urethral resistance. It cannot reduce the size of the prostate gland, so it cannot fundamentally prevent the development of benign prostatic hyperplasia, while the effect on large volume benign prostatic hyperplasia is not obvious, and it is contraindicated in patients with renal insufficiency; 3 Traditional medicines, which can only be used as a supplementary drug.
Surgery is the second-line treatment of BPH, and its standard procedure is transurethral resection of the prostate (TURP), which is considered to be the gold standard surgical procedure due to its exact efficacy and minimally invasive nature. However, large-scale retrospective studies have shown severe complications after TURP, especially TURP syndrome, postoperative urinary incontinence, urethral stricture, etc., hence there are still many concerns about the application of this procedure. Although plasma transurethral resection of the prostate and various laser prostate surgeries have sprung up in recent years, the basic surgical operation concept is not changed and the common problems existing in the procedure cannot be completely avoided. Luckily, with the development of technology, more and more new and effective treatments have emerged for BPH.
In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading to necrosis of tumor or diseased cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device, may have the potential to conquer these disadvantages.
Purpose:
- This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device in the treatment of BPH.
- This study will assess the safety of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device in the treatment of BPH.
Methods:
- patients recruitment
- Irreversible Electroporation of malignant diseased Cell under Composite Steep-pulse Treatment for the patients with Benign Prostatic Hyperplasia;
- Some factors such as prostate MRI, IPSS score, Qmax will be performed to evaluate the efficacy of the treatment.
- Other factors such as the routine blood test, the routine urine test, the blood biochemistry test, ect. will be performed to evaluate the safety of the treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Composite Steep-pulse Treatment Device | Experimental | Device: Composite Steep-pulse Treatment DeviceComposite Steep-pulse(High-frequency irreversible electroporation) Treatment Device |
| Tamsulosin | Active comparator | Drug: Tamsulosin Hydrochloride CapsulesTamsulosin Hydrochloride Sustained Release Capsules, 0.2mg, once a day,3 months |
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)
- Males between 50 to 80 years old;
- Patients who Fully understand the treatment plan for irreversible electroporation, and accept the trial treatment and signed informed consent form;
- International Prostate Symptom Score (IPSS)≥12;
- Patients who have no willing to perform enucleation or transurethral resection of prostate;
- Maximum urinary flow rate (Qmax) >5ml/min and ≤15ml/min, voided volume ≥150ml;
Key exclusion criteria (10 listed)
- Patients with a history of prostate cancer, or who confirmed diagnosis of prostate cancer (needle biopsy of the prostate is required for patients indicated for needle aspiration, and if the needle result suggests benign prostatic hyperplasia, enrollment is allowed);
- Patients with second-degree or higher atrioventricular block and other cardiac diseases with clear contraindications to anesthesia;
- Patients with cardiac pacemakers and metallic replacement of pelvis or hip joints;
- Patients who underwent previous prostate surgery for benign prostatic hyperplasia;
- patients who have history of soft or rigid cystoscopy or other transurethral device use within 7 days prior to Informed Consent Form signed;
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 |
|---|---|---|
| Composite Steep-pulse Treatment DeviceApplying the Composite Steep-pulse Treatment Device to treat the patients with Benign Prostatic Hyperplasia | Device | Composite Steep-pulse Treatment Device |
| Tamsulosin Hydrochloride CapsulesApplying Tamsulosin Hydrochloride Capsules to treat the patients with Benign Prostatic Hyperplasia | Drug | Tamsulosin |
Primary outcome
Difference value in urinary Qmax between 3 months after treatment with baseline.
Time frame: 0,3 months
The Qmax was measured before treatment, 1 month and 3 months after treatment,and baseline difference values (posttreatment-Pretreatment) were calculated. The difference value of Qmax at 3 months after treatment with baseline was used as the primary outcome.
4 secondary outcomes
Difference value of size of prostate between different visits
Time frame: 0,3 months
Difference value of Qmax between different visits
Time frame: 0,1,3 months
Difference value of IPSS score between different visits
Time frame: 0,1,3 months
Operability of host system of device
Time frame: The day of surgery
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 7 Sep 2022.
- Background: PubMed 18082216Roehrborn CG, Siami P, Barkin J, Damiao R, Major-Walker K, Morrill B, Montorsi F; CombAT Study Group. The effects of dutasteride, tamsulosin and combination therapy on lower urinary tract symptoms in men with benign prostatic hyperplasia and prostatic enlargement: 2-year results from the CombAT study. J Urol. 2008 Feb;179(2):616-21; discussion 621. doi: 10.1016/j.juro.2007.09.084. Epub 2007 Dec 21.
- 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.
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?
A Phase 2/3 study testing Composite Steep-pulse Treatment Device and Tamsulosin Hydrochloride Capsules in people with Benign Prostatic Hyperplasia, run by REMD Medical Technology at 1 site in China.
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 10 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 7 Sep 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 China. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 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?
Difference value in urinary Qmax between 3 months after treatment with baseline. (time frame: 0,3 months). 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 NCT05531344, 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 7 Sep 2022.