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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Benign Prostatic Hyperplasia
- Sponsor
- Shanghai East Hospital
- Enrollment
- 118
- Locations
- 1
- Primary Endpoint
- maximum urinary flow rate(Qmax)
- Status
- Recruiting
- Last Updated
- last year
Overview
Brief Summary
This trial is comparing the effects and safety in treating men with benign prostatic hyperplasia between high freqnence irreversible electroporation and trans urethral resection prostate.
Detailed Description
A Prospective, Single-center, Randomized Controlled Trial Comparing the Efficacy and Safety of High-Frequency Irreversible Electroporation and Trans Urethral Resection Prostate for Benign Prostatic Hyperplasia One hundred and seventy-six patients with benign prostatic hyperplasia will include in this study. The clinical trial validation process will be as follows: (1) all patients are randomly divided into two arms: arm 1, high-freqnence irreversible electroporation; arm 2, transurethral resection prostate. The primary outcome is the change in maximum urinary flow rate and urinary symptoms by questionnaire of International Prostate Symptom Score at 3 months after surgical treatment.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age over 40 years old
- •Qmax \<15ml/s
- •Prostatic volume range of 30 to 100ml, measured by MRI
- •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
Outcomes
Primary Outcomes
maximum urinary flow rate(Qmax)
Time Frame: 1 and 3 months after surgical treatment
the change from baseline in maximum urinary flow rate(Qmax)
urination function(evaluated by International prostate symptom score, IPSS)
Time Frame: 1 and 3 months after surgical treatment
the change from baseline in IPSS (International prostate symptom score)
Secondary Outcomes
- sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5)(1 and 3 months after surgical treatment)
- sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex)(1 and 3 months after surgical treatment)
- post-void residual urine volume (PVRU)(1 and 3 months after surgical treatment)
- urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire)(1 and 3 months after surgical treatment)
- urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item(1 and 3 months after surgical treatment)
- quality of life (QOL) evaluated by IPSS QoL subscore(1 and 3 months after surgical treatment)
- quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS))(1 and 3 months after surgical treatment)
- perioperative parameters(operative time)(1 month)
- perioperative parameters(the postoperative hospital stay)(1 month)
- perioperative parameters(haemoglobin declination)(6 hours, 24 hours after surgical treatment)
- perioperative parameters(serum sodium declination)(6 hours, 24 hours after surgical treatment)
- perioperative parameters(catheterisation duration)(1 month)
- early postoperative urinary symptoms(1 and 3 months after surgical treatment)
- pain measured by a surgical pain scale(24 hours, 1 week, 1 month and 3 months)
- adverse event(1 and 3 months after surgical treatment)
- voided volume(1 and 3 months after surgical treatment)