Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms

Study Overview
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Brief Summary
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Randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution

Detailed Description
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The study is a randomized controlled trial with one-year follow-up comparing intra, peri and postoperative outcomes (efficacy, complications and sequelae) for plasmakinetic transurethral resection of prostate (PK-TURP) and monopolar transurethral resection of prostate (M-TURP) in the treatment of LUTS due to BPH in a tertiary-care public institution (Madrid, Spain)

Official Title
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Randomized Controlled Trial Comparing Bipolar Plasmakinetic Transurethral Resection of the Prostate With Monopolar Transurethral Resection of the Prostate in the Treatment of Lower Urinary Tract Symptoms Due to Benign Prostatic Hyperplasia

Conditions
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Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Transurethral Resection of Prostate

Intervention / Treatment
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* Device: Transurethral Resection of the Prostate (TURP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sign the informed consent voluntarily and will be willing to follow-up Prostate volume <80 g Meet any conditions (1) Diagnose of LUTS due to refractory to drugs BPH. (2) presenting complications derived from BPH (bladder calculi, recurrent haematuria, recurrent urinary tract infections, acute urinary retention) The use of antiplatelet agents or anticoagulant drugs is allowed. Exclusion Criteria: Previous history of pelvic surgery Previous history of pelvic radiotherapy Previous history of neurogenic bladder dysfunction Documented or suspected prostate carcinoma Patients with severe cardiopulmonary disease or severe mental disorders Poor compliance, and can not be followed up.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: M-TURP<br>The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine 1.5%, Baxter). The system consists of a generator unit (ForceTriadTM, Medtronic) and a stainless steel loop with an electrical current running through the loop used to cut (120W) prostate tissue and cauterize (80W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator | Device: Transurethral Resection of the Prostate (TURP)<br>* Randomized allocation to M-TURP or PK-TURP<br>|
| Experimental: PK-TURP<br>The PK-TURP procedure requires the use of a resectoscope (Storz, 26Ch), camera system and irrigation fluid (NaCl 0.9%, Baxter). The system consists of a generator unit (PlasmaKineticTM Superpulse de Gyrus, ACMI) and a platinum-iridium superloop with an electrical current running through the loop used to cut (180W) prostate tissue and cauterize (100W). Prostate tissue is cut away in small pieces and removed at the end of the procedure using an Ellik evacuator | Device: Transurethral Resection of the Prostate (TURP)<br>* Randomized allocation to M-TURP or PK-TURP<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International Prostate Symptom Score (IPSS) | International Prostate Symptom Score (with 7 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 7 items will range between 0 to 35 points Interpretation: allows categorizing the lower urinary tract symptoms (LUTS) in 3 categories Mild LUTS: 0-7 points Moderate LUTS: 8-19 points Severe LUTS: 20-35 points | 12 months | 
| Maximum Urinary Flow Rate (Qmax | Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery. | 12 months | 
| Postvoid Residual Urine (PVRU) Volume | Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire | We use the bother score item of the IPSS questionnaire (question 8) at 1, 3, 6, and 12 months after surgery to assess the quality of life (QoL) due to lower urinary tract symptoms (LUTS) Results: will range between 0 to 6 points Interpretation: allows categorizing the QoL in 3 categories Good QoL: 0-2 points Intermediate QoL: 3 points Poor QoL: 4-6points | 12 months | 
| Number of Participants Reporting Sexual Activity in the Last Month | Measure Description: All patients were asked, Did you have sexual activity in the last month? Possible answers were yes or no. Possible answers: yes or no. Measurement moment: at 1, 3, 6 and 12 months after surgery. | 12 months | 
| International Index of Erectile Function (IIEF-5) | International Index of Erectile Function (with 5 questions) at 1, 3, 6, and 12 months after surgery. Results: the sum of the 5 items will range between 1 to 25 points Interpretation: allows categorizing the erectile function of patients Without erectile dysfunction: 22-25 points Mild erectile dysfunction: 17-21 points Mild to moderate erectile dysfunction: 12-16 points Moderate erectile dysfunction: 8-11 points Severe erectile dysfunction: 1-7 points | 12 months | 
| Prostate Volume (PV) | Prostate volume was measured by transrectal ultrasound at 12 months after surgery | 12 months | 
| Operative Time | Operative time (min) | Up to 24 hours | 
| Irrigation Volume | Irrigation volume (L) | Up to 24 hours | 
| Change in Plasmatic Sodium in 24 Hours Post-operation | Compared with the baseline, to demonstrate the sodium loss during operation | 24 hours after surgery | 
| Change in Haemoglobin in 24 Hours Post-operation | Compared with the baseline, to demonstrate the blood loss during operation | 24 hours after surgery | 
| Transfusion Rate | Number of participants requiring blood transfusion during, expressed in % | 1 month | 
| Catheter Duration | Catheter duration (days) | 1 month | 
| Hospital Stay | Hospital stay (days) | 1 month | 
| Resected Tissue Weigh | Resected tissue weigh (grams) | Up to 24 hours | 
| Resected Tissue Percentage | Compared with the baseline, to demonstrate the % of tissue loss during operation | Up to 24 hours | 
| Speed Resection | Speed resection (g/min) | Up to 24 hours | 
| Early Reoperation Rate | The ratio of patient who need reoperation because bleeding complications | 1 month | 
| Late Reoperation Rate | The ratio of patient who need reoperation because residual adenoma or complications | 12 months | 
| Post-TURP Syndrome Rate | Post-transurethral resection of the prostate syndrome rate was recorded. | Up to 24 hours | 
| Clavien Dindo System | It is a system for evaluating surgical complications at 12 months after surgery. Clavien I Any deviation from the normal postoperative course without the need for pharmacological treatment or surgical, endoscopic, and radiological interventions. Acceptable therapeutic regimens are drugs as antiemetics, antipyretics, analgesics, diuretics and electrolytes, and physiotherapy. Clavien II Requiring pharmacological treatment with drugs other than such allowed for grade I complications. Blood transfusions and total parenteral nutrition are also included Clavien III - Requiring surgical, endoscopic or radiological intervention Clavien IV - Life-threatening complication (including central nervous system complications) requiring intensive care unit management Clavien V - Death of a patient | 12 months | 
| Bleeding Complications Rate | Register the number of events of haematuria and acute urinary retention by clots | 1 month | 
| Urinary Tract Infections Rate | Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery. | 12 months | 
| Stenotic Complications Rate: Meatal Stenosis | Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery. | 12 months | 
| Stenotic Complications Rate: Urethral Stricture | Register the number of urethral stricture at 1, 3, 6, and 12 after surgery. | 12 months | 
| Stenotic Complications Rate: Bladder Neck Contracture | Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery. | 12 months | 
| Stress Urinary Incontinence Rate | Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery. | 12 months | 
| Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate | Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery. | 12 months | 
| Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate | Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery. | 12 months | 
| Sequelae Rate: Retrograde Ejaculation | register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery. | 12 months | 
| Sequelae Rate: Dysuria | register the number of dysuria at 1, 3, 6, and 12 after surgery. | 12 months |