Comparing two treatments for benign prostatic hyperplasia
A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High Freqnence Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia
NA · Shanghai East Hospital · NCT05306145
This study is testing whether a new treatment using high-frequency electroporation works better than the standard surgery for men with enlarged prostates to see which one helps improve their urinary flow and symptoms.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 118 (estimated) |
| Ages | 40 Years and up |
| Sex | Male |
| Sponsor | Shanghai East Hospital (other) |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05306145 on ClinicalTrials.gov |
What this trial studies
This clinical trial compares the efficacy and safety of high-frequency irreversible electroporation with transurethral resection of the prostate in men suffering from benign prostatic hyperplasia. A total of 176 patients will be randomly assigned to one of the two treatment arms. The primary outcomes will focus on changes in maximum urinary flow rate and urinary symptoms, assessed using the International Prostate Symptom Score at three months post-treatment. The study aims to provide insights into which treatment may offer better results for patients.
Who should consider this trial
Good fit: Ideal candidates for this study are men over 40 years old with moderate to severe urinary symptoms and specific prostate volume measurements.
Not a fit: Patients with a history of prostate cancer or those with certain urinary tract conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for men with benign prostatic hyperplasia.
How similar studies have performed: While there have been studies on both treatments, this specific comparison of high-frequency irreversible electroporation against transurethral resection is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age over 40 years old 2. IPSS\>8 3. Qmax \<15ml/s 4. Prostatic volume range of 30 to 100ml, measured by MRI 5. Fully understand the clinical trial protocol and sign the informed consent Exclusion Criteria: Have a history of prostate cancer or patients suspicious of prostate cancer Neurogenic bladder Metal implants in their body Previous history of prostatic or urethral surgery With Catheterisation more than 2 weeks Any other conditions that investigator judges that participations who are not suitable for this trial
Where this trial is running
Shanghai
- Haifeng Wang — Shanghai, China (RECRUITING)
Study contacts
- Principal investigator: Haifeng Wang — Shanghai East Hospital,Tongji University School of Medicine
- Study coordinator: Biming He
- Email: 190589109@qq.com
- Phone: +8615502139410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate