Benign Prostatic Hyperplasia
Conditions
Keywords
Benign Prostatic Hyperplasia, High freqnence Irreversible electroporation, Trans Urethral Resection Prostate
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.
Interventions
PROCEDUREHigh freqnence Irreversible electroporation
High freqnence Irreversible electroporation will be performed via the perineum with the guidance of ultrasound under general anaesthesia to the patient with benign prostatic hyperplasia
PROCEDURETrans Urethral Resection Prostate
Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic
Sponsors
Shanghai East Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| maximum urinary flow rate(Qmax) | 3 months after surgical treatment | the change from baseline in maximum urinary flow rate(Qmax) |
| urination function(evaluated by International prostate symptom score, IPSS) | 3 months after surgical treatment | the change from baseline in IPSS (International prostate symptom score) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5) | 3 months after surgical treatment | the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5) |
| sexual function evaluated by the International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex) | 3 months after surgical treatment | the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex) |
| post-void residual urine volume (PVRU) | 3 months after surgical treatment | the change from the baseline in the post-void residual urine volume (PVRU) |
| urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire) | 3 months after surgical treatment | the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire) |
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 3 months after surgical treatment | the change from the baseline in urinary incontinence, evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item |
| quality of life (QOL) evaluated by IPSS QoL subscore | 3 months after surgical treatment | the change from the baseline in QOL, evaluated by IPSS QoL subscore |
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | 3 months after surgical treatment | the change from the baseline in QOL, evaluated by Hospital Anxiety and Depression Scale (HADS) |
| perioperative parameters(operative time) | Day 0 (During surgical procedure) | operative time |
| perioperative parameters(the postoperative hospital stay) | Up to hospital discharge (assessed up to 1 month) | the postoperative hospital stay |
| perioperative parameters(haemoglobin declination) | 6 hours, 24 hours after surgical treatment | haemoglobin declination |
| perioperative parameters(serum sodium declination) | 6 hours, 24 hours after surgical treatment | serum sodium declination |
| perioperative parameters(catheterisation duration) | Up to catheter removal (assessed up to 1 month) | catheterisation duration |
| early postoperative urinary symptoms | 3 months after surgical treatment | include dysuria, urgency, or post micturition pain |
| pain measured by a surgical pain scale | 24 hours, 1 week, 1 month and 3 months | pain measured by a surgical pain scale range from 0 to 10 |
| adverse event | Up to 3 months after surgical treatment | including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation. |
| voided volume | 3 months after surgical treatment | the change from the baseline in voided volume |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORHaifeng Wang
Shanghai East Hospital,Tongji University School of Medicine
Outcome results
None listed