Composite Steep-pulseTreatment Device Used in Patients With Benign Prostatic Hyperplasia

NCT05531344 | Completed Phase 2

• 1 other identifier: REMD02
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Benign Prostatic Hyperplasia

Keywords

IRE; Composite Steep-pulse Treatment Device; Benign Prostatic Hyperplasia; randomized; medication-control; superiority; multi-center

Outcome Measures

Primary Outcomes (1)

• 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.

  0,3 months

Secondary Outcomes (4)

• Difference value of size of prostate between different visits

  0,3 months

• Difference value of Qmax between different visits

  0,1,3 months

• Difference value of IPSS score between different visits

  0,1,3 months

• Operability of host system of device

  The day of surgery

Study Arms (2)

Composite Steep-pulse Treatment Device

EXPERIMENTAL

Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Device

Device: Composite Steep-pulse Treatment Device

Tamsulosin

ACTIVE COMPARATOR

Tamsulosin Hydrochloride Sustained Release Capsules, 0.2mg, once a day,3 months

Drug: Tamsulosin Hydrochloride Capsules

Interventions

Composite Steep-pulse Treatment Device DEVICE

Applying the Composite Steep-pulse Treatment Device to treat the patients with Benign Prostatic Hyperplasia

Composite Steep-pulse Treatment Device

Tamsulosin Hydrochloride Capsules DRUG

Applying Tamsulosin Hydrochloride Capsules to treat the patients with Benign Prostatic Hyperplasia

Tamsulosin

Eligibility Criteria

• Age: 50 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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.

Sponsors & Collaborators

• REMD Medical Technology: lead
• RenJi Hospital: collaborator
• Dongfang Hospital Affiliated to Tongji University: collaborator
• Shanghai Pudong Hospital: collaborator
• Qilu Hospital of Shandong University: collaborator
• Ningbo No.2 Hospital: collaborator
• Shangdong Yiyuan Hospital: collaborator
• Tongji Hospital: collaborator
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Hunan Provincial People's Hospital: collaborator

Study Sites (1)

Remd Medical Technology

Shanghai, Shanghai Municipality, 200000, China

Location

Related Publications (1)

• 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.

  PMID: 18082216 BACKGROUND

MeSH Terms

Conditions

Prostatic Hyperplasia

Interventions

Tamsulosin

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Benzenesulfonamides; Sulfonamides; Amides; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2022
• First Posted: September 7, 2022
• Study Start: August 20, 2020
• Primary Completion: July 8, 2022
• Study Completion: July 8, 2022
• Last Updated: September 7, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)