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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Freqnence Irreversible Electroporation | Experimental | Using high freqnence irreversible electroporation to treat patients with benign prostatic hyperplasia |
|
| Trans Urethral Resection Prostate | Active Comparator | Using trans urethral resection prostate to treat patients with benign prostatic hyperplasia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High freqnence Irreversible electroporation | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| maximum urinary flow rate(Qmax) | the change from baseline in maximum urinary flow rate(Qmax) | 3 months after surgical treatment |
| urination function(evaluated by International prostate symptom score, IPSS) | the change from baseline in IPSS (International prostate symptom score) | 3 months after surgical treatment |
| Measure | Description | Time Frame |
|---|---|---|
| sexual function evaluated by International Index of Erectile Function Questionnaire-5 (IIEF-5) | the change from baseline in International Index of Erectile Function Questionnaire-5 (IIEF-5) | 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) |
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Inclusion Criteria:
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
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| Name | Affiliation | Role |
|---|---|---|
| Haifeng Wang | Shanghai East Hospital of Tongji University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haifeng Wang | Shanghai | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39788775 | Derived | He BM, Shi ZK, Chen R, Wang HF. Study protocol for a single-centre non-inferior double-blinded randomised controlled trial in China comparing the efficacy and safety of high-frequency irreversible electroporation with transurethral resection of the prostate in treating lower urinary tract symptoms and benign prostatic obstruction (the GIANT trial). BMJ Open. 2025 Jan 9;15(1):e092489. doi: 10.1136/bmjopen-2024-092489. |
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IPD used in the results publication will be shared
IPD and supporting information will be available after the first relevant article is published and last for 10 years after the latest relevant article is published.
Approvals need to be sort from the data custodians at the health services involved in line with China regulations
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
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| Trans Urethral Resection Prostate | Procedure | Trans urethral resection prostate will be performed under general anaesthesia to the patient with benign prostatic |
|
the change from baseline in International Consultation on Incontinence Questionnaire Male Sexual Matters Associated with Lower Urinary Tract Symptoms Module (ICIQ--MLUTSsex) |
| 3 months after surgical treatment |
| post-void residual urine volume (PVRU) | the change from the baseline in the post-void residual urine volume (PVRU) | 3 months after surgical treatment |
| urinary incontinence evaluated by ICIQ (International Consultation on Incontinence Questionnaire) | the change from baseline in by ICIQ (International Consultation on Incontinence Questionnaire) | 3 months after surgical treatment |
| urinary incontinence evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | the change from the baseline in urinary incontinence, evaluated by separate EPIC (Expanded Prostate Cancer Index Composite) pad-use item | 3 months after surgical treatment |
| quality of life (QOL) evaluated by IPSS QoL subscore | the change from the baseline in QOL, evaluated by IPSS QoL subscore | 3 months after surgical treatment |
| quality of life (QOL) evaluated by Hospital Anxiety and Depression Scale (HADS)) | the change from the baseline in QOL, evaluated by Hospital Anxiety and Depression Scale (HADS) | 3 months after surgical treatment |
| perioperative parameters(operative time) | operative time | Day 0 (During surgical procedure) |
| perioperative parameters(the postoperative hospital stay) | the postoperative hospital stay | Up to hospital discharge (assessed up to 1 month) |
| perioperative parameters(haemoglobin declination) | haemoglobin declination | 6 hours, 24 hours after surgical treatment |
| perioperative parameters(serum sodium declination) | serum sodium declination | 6 hours, 24 hours after surgical treatment |
| perioperative parameters(catheterisation duration) | catheterisation duration | Up to catheter removal (assessed up to 1 month) |
| early postoperative urinary symptoms | include dysuria, urgency, or post micturition pain | 3 months after surgical treatment |
| pain measured by a surgical pain scale | pain measured by a surgical pain scale range from 0 to 10 | 24 hours, 1 week, 1 month and 3 months |
| adverse event | including TUR syndrome, blood transfusion, clot retention, uti, transient incontience, retrograde ejaculation. | Up to 3 months after surgical treatment |
| voided volume | the change from the baseline in voided volume | 3 months after surgical treatment |
| D052801 |
| Male Urogenital Diseases |