Lower Urinary Tract SymptomsPhase 2NCT03448510
Irreversible Electroporation Versus Standard Medication for Benign Prostatic Obstruction
A Phase 2 study testing Irreversible electroporation and Standard Medication in people with Lower Urinary Tract Symptoms, run by Changhai Hospital at 1 site in China.
Trial summary
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, lung, liver and kidney masses. Read more about this study
- Who is it for?
- Ages 45 years and older, men only
- Conditions the study is for
- Lower Urinary Tract Symptoms
- What is being tested?
- Irreversible electroporation and Standard Medication
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2018to 30 May 2019
- Phase
- Phase 2
- 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 45 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male, 45 years or older.
- The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc.
- Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study.
- The presence of bladder outlet obstruction during pressure-flow study.
- International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
- Prostate volume ≥ 30 ml (using a transrectal ultrasound approach).
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- Total serum prostatic specific antigen (PSA) ≥ 1.5 ng/mL and ≤ 10 ng/mL at screening.
- Subject is able to communicate and complete the questionnaires properly.
- Written informed consent.
Who cannot join
- Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
- Patients with arrhythmia or history of cardiac pacemaker implantation.
- Known lower urinary tract or pelvic surgical history.
- Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
- Known neurogenic or congenital lower urinary tract dysfunction.
- Rigid or flexible cystoscopy examination within the past 7 days at screening.
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- Existence of anatomical abnormalities of the urinary tract (e.g. diverticulum of the bladder or urethra, ectopic ureteral orifice etc.).
- The presence of acute conditions, such as, urinary tract infection, fever, heart failure etc.
- Patients with poor compliance or cognitive competence.
Trial locations and contacts
1 site in 1 country.
China1 site
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Haifeng Wang, MD, PhD, 13681750891, 446720864@qq.com
Qi-Xiang Song, MD, PhD, 15021223013, rex_song918@qq.com
About this study
Official title: The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, lung, liver and kidney masses. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.
Read the detailed description
Benign prostatic obstruction (BPO) is the main reason to cause lower urinary tract symptoms (LUTS) in aged male. Oral medications, such as,α1-adrenoceptor antagonist and 5α-reductase inhibitors are the mainstay treatment options. However, some patients can not tolerate long-term use, due to either side effects or limited efficacy. Though transurethral resection or enucleation of prostate usually achieve significant symptom improvement, it's an end stage procedure and it is only reserved for carefully selected patients.
The development of focal ablative therapy yields minimally invasive treatment option for primary tumors such as the liver, lung, pancreas, kidney, and prostate. Among the novel techniques are cryoablation, radiofrequency ablation (RFA), microwave ablation, and high-intensity focused ultrasonography. Irreversible electroporation (IRE) is a one of the ablation modalities using electric pulses to create nanoscale defects in the cell membrane. IRE is not dependent on thermal energy and is therefore causing minimum damage to the blood vessels, nerves and tissue architecture. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.
- Conditions
- Lower Urinary Tract Symptoms
- Being tested
- Irreversible electroporation, Standard Medication
- Keywords
- lower urinary tract symptoms, male, benign prostatic obstruction, irreversible electroporation, urodynamics
- Medical subject headings
- Lower Urinary Tract Symptoms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Irreversible electroporationDevice
The subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
Standard MedicationDrug
The subject will be prescribed with α-blocker or/and 5α-reductase inhibitors.
| Study group | Role | What they receive |
|---|---|---|
| Irreversible electroporation treatment | Experimental | Subjects will receive irreversible electroporation of the prostate Receives: Device: Irreversible electroporation |
| standard medication group | Active comparator | Subjects will receive either α-blocker or 5α reductase monotherapy or combination therapy. Receives: Drug: Standard Medication |
What is being measured
The primary outcome is the main question the study is designed to answer.
The changes of maximum flow rate (ml/s) between baseline and during follow-up
Maximum flow rate will be measured using urinary flow study
Measured: Measured at baseline and 1, 3, 6 months during follow-up
Secondary outcomes (5)
The changes of IPSS scores between baseline and during follow-up
Measured using a standard IPSS scoring system
Measured: Measured at baseline and 1, 3, 6 months during follow-up
The changes of IIEF scores between baseline and during follow-up
Measured using a standard IIEF scoring system
Measured: Measured at baseline and 1, 3, 6 months during follow-up
The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up
The data will be captured during pressure flow study
Measured: Measured at baseline and 3, 6 months during follow-up
The changes of post void residual volume (ml) between baseline and follow-up
Post void residual volume (ml) will be measured via ultrasound
Measured: Measured at baseline and 1, 3, 6 months during follow-up
The changes of prostate volume (ml) between baseline and follow-up
Prostate volume (ml) will be measured using transrectal prostate ultrasound and calculated as: prostate volume (ml) = length (mm) * width (mm) * height (mm) * 0.52.
Measured: Measured at baseline and 1, 3, 6 during follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2018
- Study start1 Apr 2018 (estimated)
- Primary completion31 Jan 2019 (estimated)
- Study completion30 May 2019 (estimated)
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 Lower Urinary Tract SymptomsStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yinghao Sun, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03448510
- Sponsor's protocol ID
- IRE-2018
- Status last verified
- Feb 2018
- First submitted
- 22 Feb 2018
- Last updated
- 28 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wagstaff PG, Buijs M, van den Bos W, de Bruin DM, Zondervan PJ, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation: state of the art. Onco Targets Ther. 2016 Apr 22;9:2437-46. doi: 10.2147/OTT.S88086. eCollection 2016.
PubMed 27217767
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Irreversible Electroporation Versus Standard Medication for the Treatment of Benign Prostatic Obstruction: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03448510
- Acronym / sponsor ID
- IRE-2018
- Conditions
- Lower Urinary Tract Symptoms
- Keywords
- lower urinary tract symptoms, male, benign prostatic obstruction, irreversible electroporation, urodynamics
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Study start
- 1 Apr 2018 (estimated)
- Primary completion
- 31 Jan 2019 (estimated)
- Study completion
- 30 May 2019 (estimated)
- First posted
- 28 Feb 2018 (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.
Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. It has been verified to be safe on the treatment of prostate, lung, liver and kidney masses. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.
Detailed description
Benign prostatic obstruction (BPO) is the main reason to cause lower urinary tract symptoms (LUTS) in aged male. Oral medications, such as,α1-adrenoceptor antagonist and 5α-reductase inhibitors are the mainstay treatment options. However, some patients can not tolerate long-term use, due to either side effects or limited efficacy. Though transurethral resection or enucleation of prostate usually achieve significant symptom improvement, it's an end stage procedure and it is only reserved for carefully selected patients.
The development of focal ablative therapy yields minimally invasive treatment option for primary tumors such as the liver, lung, pancreas, kidney, and prostate. Among the novel techniques are cryoablation, radiofrequency ablation (RFA), microwave ablation, and high-intensity focused ultrasonography. Irreversible electroporation (IRE) is a one of the ablation modalities using electric pulses to create nanoscale defects in the cell membrane. IRE is not dependent on thermal energy and is therefore causing minimum damage to the blood vessels, nerves and tissue architecture. The present is a randomized, controlled trial, with a main purpose of looking into the safety and feasibility of irreversible electroporation for patients with benign prostatic obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Irreversible electroporation (IRE) is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane.
| Arm | Type | Receives |
|---|---|---|
| Irreversible electroporation treatment | Experimental | Device: Irreversible electroporationSubjects will receive irreversible electroporation of the prostate |
| standard medication group | Active comparator | Drug: Standard MedicationSubjects will receive either α-blocker or 5α reductase monotherapy or combination therapy. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male, 45 years or older.
- The presence of voiding symptoms, i.e. slow stream, intermittent stream, hesitancy, straining, etc.
- Qmax ≥ 5 mL/s and ≤ 15 mL/s with minimum voided volume of 125 mL or more during flow study.
- The presence of bladder outlet obstruction during pressure-flow study.
- International Prostatic Symptom Score (IPSS) ≥ 12 at screening.
Key exclusion criteria (9 listed)
- Diagnosis or suspicion of bladder, prostate, urethral or pelvic tumor.
- Patients with arrhythmia or history of cardiac pacemaker implantation.
- Known lower urinary tract or pelvic surgical history.
- Voiding symptoms as a result of urethral stricture, stone diseases, chronic prostatitis, space-occupying lesions etc.
- Known neurogenic or congenital lower urinary tract dysfunction.
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 |
|---|---|---|
| Irreversible electroporationThe subject will receive Irreversible electroporation procedure which is a novel ablation modality using electric pulses to create nanoscale defects in the cell membrane. | Device | Irreversible electroporation treatment |
| Standard MedicationThe subject will be prescribed with α-blocker or/and 5α-reductase inhibitors. | Drug | standard medication group |
Primary outcome
The changes of maximum flow rate (ml/s) between baseline and during follow-up
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
Maximum flow rate will be measured using urinary flow study
5 secondary outcomes
The changes of IPSS scores between baseline and during follow-up
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
The changes of IIEF scores between baseline and during follow-up
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
The changes of maximum detrusor pressure at maximum flow rate between baseline and during follow-up
Time frame: Measured at baseline and 3, 6 months during follow-up
The changes of post void residual volume (ml) between baseline and follow-up
Time frame: Measured at baseline and 1, 3, 6 months during follow-up
The changes of prostate volume (ml) between baseline and follow-up
Time frame: Measured at baseline and 1, 3, 6 during follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2018.
- Background: PubMed 27217767Wagstaff PG, Buijs M, van den Bos W, de Bruin DM, Zondervan PJ, de la Rosette JJ, Laguna Pes MP. Irreversible electroporation: state of the art. Onco Targets Ther. 2016 Apr 22;9:2437-46. doi: 10.2147/OTT.S88086. eCollection 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Irreversible electroporation and Standard Medication in people with Lower Urinary Tract Symptoms, run by Changhai Hospital 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 9 inclusion and 9 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 28 Feb 2018. 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The changes of maximum flow rate (ml/s) between baseline and during follow-up (time frame: Measured at baseline and 1, 3, 6 months during follow-up). 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 NCT03448510, 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 28 Feb 2018.