Trial Outcomes & Findings for Bipolar Plasmakinetic TURP Vs Monopolar TURP in the Treatment of Lower Urinary Tract Symptoms (NCT NCT03936244)

NCT ID: NCT03936244

Last Updated: 2020-11-12

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 100 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2020-11-12

Participant Flow

Participant milestones

Measure	M-TURP The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Overall Study STARTED	57	43
Overall Study COMPLETED	45	39
Overall Study NOT COMPLETED	12	4

Reasons for withdrawal

Measure	M-TURP The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Overall Study Lost to Follow-up	5	1
Overall Study Physician Decision	7	3

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	M-TURP n=45 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	Total n=84 Participants Total of all reporting groups
Age, Continuous	64.9 years STANDARD_DEVIATION 7.2 • n=45 Participants	66.2 years STANDARD_DEVIATION 7.1 • n=39 Participants	65.5 years STANDARD_DEVIATION 7.2 • n=84 Participants
Sex: Female, Male Female	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=84 Participants
Sex: Female, Male Male	45 Participants n=45 Participants	39 Participants n=39 Participants	84 Participants n=84 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Body mass index (BMI)	27.9 kg/m^2 STANDARD_DEVIATION 4.2 • n=45 Participants	26.8 kg/m^2 STANDARD_DEVIATION 4.2 • n=39 Participants	27.4 kg/m^2 STANDARD_DEVIATION 4.2 • n=84 Participants
Hypertension	27 Participants n=45 Participants	18 Participants n=39 Participants	45 Participants n=84 Participants
Diabetes mellitus	7 Participants n=45 Participants	6 Participants n=39 Participants	13 Participants n=84 Participants
Smoker	7 Participants n=45 Participants	6 Participants n=39 Participants	13 Participants n=84 Participants
ASA classification ASA I	1 Participants n=45 Participants	1 Participants n=39 Participants	2 Participants n=84 Participants
ASA classification ASA II	38 Participants n=45 Participants	33 Participants n=39 Participants	71 Participants n=84 Participants
ASA classification ASA III	6 Participants n=45 Participants	5 Participants n=39 Participants	11 Participants n=84 Participants
Serum PSA	2 ng/mL STANDARD_DEVIATION 3 • n=45 Participants	1.3 ng/mL STANDARD_DEVIATION 0.9 • n=39 Participants	1.7 ng/mL STANDARD_DEVIATION 2.2 • n=84 Participants
Creatinine	0.9 mg/dL STANDARD_DEVIATION 0.3 • n=45 Participants	0.9 mg/dL STANDARD_DEVIATION 0.1 • n=39 Participants	0.9 mg/dL STANDARD_DEVIATION 0.3 • n=84 Participants
Serum sodium	140.8 mEq/L STANDARD_DEVIATION 2.3 • n=45 Participants	140.5 mEq/L STANDARD_DEVIATION 2.5 • n=39 Participants	140.7 mEq/L STANDARD_DEVIATION 2.4 • n=84 Participants
Hemoglobin	14.7 g/dL STANDARD_DEVIATION 1.3 • n=45 Participants	15.1 g/dL STANDARD_DEVIATION 1.1 • n=39 Participants	14.9 g/dL STANDARD_DEVIATION 1.2 • n=84 Participants
IPSS	24.7 units on a scale STANDARD_DEVIATION 6.1 • n=45 Participants	23.8 units on a scale STANDARD_DEVIATION 4.8 • n=39 Participants	24.3 units on a scale STANDARD_DEVIATION 6.1 • n=84 Participants
QoL score	5.2 units on a scale STANDARD_DEVIATION 0.8 • n=45 Participants	4.8 units on a scale STANDARD_DEVIATION 1.3 • n=39 Participants	5.1 units on a scale STANDARD_DEVIATION 1.1 • n=84 Participants
Number of Participants Reporting Sexual Activity in the Last Month	37 Participants n=45 Participants	28 Participants n=39 Participants	65 Participants n=84 Participants
IIEF score	11.7 units on a scale STANDARD_DEVIATION 7.1 • n=45 Participants	10.5 units on a scale STANDARD_DEVIATION 7.9 • n=39 Participants	11.2 units on a scale STANDARD_DEVIATION 7.5 • n=84 Participants
Qmax	10.9 mL/s STANDARD_DEVIATION 5.5 • n=45 Participants	9.3 mL/s STANDARD_DEVIATION 4 • n=39 Participants	10.1 mL/s STANDARD_DEVIATION 4.9 • n=84 Participants
PVRU volume	60.6 mL STANDARD_DEVIATION 83.4 • n=45 Participants	93.1 mL STANDARD_DEVIATION 91.1 • n=39 Participants	75.9 mL STANDARD_DEVIATION 88.0 • n=84 Participants
PV by TRUS	38.3 mL STANDARD_DEVIATION 17.4 • n=45 Participants	41.4 mL STANDARD_DEVIATION 17.1 • n=39 Participants	39.7 mL STANDARD_DEVIATION 17.2 • n=84 Participants
Stress urinary incontinence	0 Participants n=45 Participants	0 Participants n=39 Participants	0 Participants n=84 Participants
Urge urinary incontinence with need for drug use (UUIND)	1 Participants n=45 Participants	2 Participants n=39 Participants	3 Participants n=84 Participants
urge Urinary incontinence without the need for drug use (UUIWND)	13 Participants n=45 Participants	9 Participants n=39 Participants	22 Participants n=84 Participants
Retrograde ejaculation	5 Participants n=45 Participants	3 Participants n=39 Participants	8 Participants n=84 Participants
Dysuria	5 Participants n=45 Participants	6 Participants n=39 Participants	11 Participants n=84 Participants
Drugs for hemostasis None	31 Participants n=45 Participants	30 Participants n=39 Participants	61 Participants n=84 Participants
Drugs for hemostasis Antiaggregants	12 Participants n=45 Participants	5 Participants n=39 Participants	17 Participants n=84 Participants
Drugs for hemostasis Anticoagulants	2 Participants n=45 Participants	4 Participants n=39 Participants	6 Participants n=84 Participants
Drugs for LUTS None	1 Participants n=45 Participants	1 Participants n=39 Participants	2 Participants n=84 Participants
Drugs for LUTS Storage symptoms	1 Participants n=45 Participants	2 Participants n=39 Participants	3 Participants n=84 Participants
Drugs for LUTS Voiding symptoms	43 Participants n=45 Participants	36 Participants n=39 Participants	79 Participants n=84 Participants
Indication of surgery Drug failure	35 Participants n=45 Participants	28 Participants n=39 Participants	63 Participants n=84 Participants
Indication of surgery Acute urinary retention (AUR)	9 Participants n=45 Participants	10 Participants n=39 Participants	19 Participants n=84 Participants
Indication of surgery Vesical calculi	1 Participants n=45 Participants	1 Participants n=39 Participants	2 Participants n=84 Participants

PRIMARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
International Prostate Symptom Score (IPSS) 1 month	14.6 points Standard Deviation 7.4	12.7 points Standard Deviation 7.4
International Prostate Symptom Score (IPSS) 3 months	12.2 points Standard Deviation 8.2	11.3 points Standard Deviation 7.8
International Prostate Symptom Score (IPSS) 6 months	9.7 points Standard Deviation 7.7	9.4 points Standard Deviation 5.9
International Prostate Symptom Score (IPSS) 12 months	9.7 points Standard Deviation 8	7.4 points Standard Deviation 4.7

PRIMARY outcome

Timeframe: 12 months

Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Maximum Urinary Flow Rate (Qmax 1 months	17.5 mL/s Standard Deviation 9	18.9 mL/s Standard Deviation 8.3
Maximum Urinary Flow Rate (Qmax 3 months	18.2 mL/s Standard Deviation 8.9	16.8 mL/s Standard Deviation 9
Maximum Urinary Flow Rate (Qmax 6 months	21 mL/s Standard Deviation 10.1	18.7 mL/s Standard Deviation 8.1
Maximum Urinary Flow Rate (Qmax 12 months	21.2 mL/s Standard Deviation 9.5	19.2 mL/s Standard Deviation 7.2

PRIMARY outcome

Timeframe: 12 months

Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Postvoid Residual Urine (PVRU) Volume 1 month	14.2 mL Standard Deviation 28.8	13 mL Standard Deviation 22.3
Postvoid Residual Urine (PVRU) Volume 3 months	22.8 mL Standard Deviation 44.9	18.2 mL Standard Deviation 26.5
Postvoid Residual Urine (PVRU) Volume 6 months	15.3 mL Standard Deviation 28.9	14.7 mL Standard Deviation 25
Postvoid Residual Urine (PVRU) Volume 12 months	14 mL Standard Deviation 28.3	8.3 mL Standard Deviation 17.7

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire 1 month	3.7 points Standard Deviation 1.9	2.9 points Standard Deviation 2.1
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire 3 months	2.9 points Standard Deviation 1.8	2.6 points Standard Deviation 1.9
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire 6 months	2.3 points Standard Deviation 1.9	1.6 points Standard Deviation 1.6
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire 12 months	2.4 points Standard Deviation 1.9	1.5 points Standard Deviation 1.2

SECONDARY outcome

Timeframe: 12 months

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.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Number of Participants Reporting Sexual Activity in the Last Month 1 month	23 Participants	22 Participants
Number of Participants Reporting Sexual Activity in the Last Month 3 months	33 Participants	28 Participants
Number of Participants Reporting Sexual Activity in the Last Month 6 months	30 Participants	29 Participants
Number of Participants Reporting Sexual Activity in the Last Month 12 months	29 Participants	30 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
International Index of Erectile Function (IIEF-5) 1 month	8.5 points Standard Deviation 7.9	9.5 points Standard Deviation 8
International Index of Erectile Function (IIEF-5) 3 months	9.9 points Standard Deviation 8.2	10.7 points Standard Deviation 8.1
International Index of Erectile Function (IIEF-5) 6 months	10.7 points Standard Deviation 8.5	12.4 points Standard Deviation 8.2
International Index of Erectile Function (IIEF-5) 12 months	9.7 points Standard Deviation 8.6	11 points Standard Deviation 8.1

SECONDARY outcome

Timeframe: 12 months

Prostate volume was measured by transrectal ultrasound at 12 months after surgery

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Prostate Volume (PV)	22.3 mL Standard Deviation 13	22.5 mL Standard Deviation 12.2

SECONDARY outcome

Timeframe: Up to 24 hours

Operative time (min)

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Operative Time	39.7 minutes Standard Deviation 14.1	47.7 minutes Standard Deviation 21.4

SECONDARY outcome

Timeframe: Up to 24 hours

Irrigation volume (L)

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Irrigation Volume	16 L Standard Deviation 6.8	20.2 L Standard Deviation 11.8

SECONDARY outcome

Timeframe: 24 hours after surgery

Compared with the baseline, to demonstrate the sodium loss during operation

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Change in Plasmatic Sodium in 24 Hours Post-operation	3.3 mEq/L Standard Deviation 4.1	2.2 mEq/L Standard Deviation 3.6

SECONDARY outcome

Timeframe: 24 hours after surgery

Compared with the baseline, to demonstrate the blood loss during operation

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Change in Haemoglobin in 24 Hours Post-operation	0.9 mg/dL Standard Deviation 1.1	1 mg/dL Standard Deviation 1.1

SECONDARY outcome

Timeframe: 1 month

Number of participants requiring blood transfusion during, expressed in %

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Transfusion Rate	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

Catheter duration (days)

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Catheter Duration	3.6 days Standard Deviation 1.4	3.5 days Standard Deviation 0.8

SECONDARY outcome

Timeframe: 1 month

Hospital stay (days)

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Hospital Stay	1.1 days Standard Deviation 0.4	1.1 days Standard Deviation 0.8

SECONDARY outcome

Timeframe: Up to 24 hours

Resected tissue weigh (grams)

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Resected Tissue Weigh	12.7 grams Standard Deviation 8.2	12.4 grams Standard Deviation 9.9

SECONDARY outcome

Timeframe: Up to 24 hours

Compared with the baseline, to demonstrate the % of tissue loss during operation

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Resected Tissue Percentage	33.5 % of resected tissue Standard Deviation 17	28.8 % of resected tissue Standard Deviation 19

SECONDARY outcome

Timeframe: Up to 24 hours

Speed resection (g/min)

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Speed Resection	0.9 g/min Standard Deviation 0.3	0.9 g/min Standard Deviation 0.3

SECONDARY outcome

Timeframe: 1 month

The ratio of patient who need reoperation because bleeding complications

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Early Reoperation Rate	2 Participants	1 Participants

SECONDARY outcome

Timeframe: 12 months

The ratio of patient who need reoperation because residual adenoma or complications

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Late Reoperation Rate	2 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 24 hours

Post-transurethral resection of the prostate syndrome rate was recorded.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Post-TURP Syndrome Rate	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

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

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Clavien Dindo System Clavien I	2 Participants	2 Participants
Clavien Dindo System Clavien II	2 Participants	2 Participants
Clavien Dindo System Clavien III	2 Participants	1 Participants
Clavien Dindo System Clavien IV	0 Participants	0 Participants
Clavien Dindo System Clavien V	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 month

Register the number of events of haematuria and acute urinary retention by clots

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Bleeding Complications Rate	8 Participants	7 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Urinary Tract Infections Rate 1 month	5 Participants	1 Participants
Urinary Tract Infections Rate 3 months	0 Participants	0 Participants
Urinary Tract Infections Rate 6 months	0 Participants	0 Participants
Urinary Tract Infections Rate 12 months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Stenotic Complications Rate: Meatal Stenosis 1 month	2 Participants	2 Participants
Stenotic Complications Rate: Meatal Stenosis 3 months	5 Participants	2 Participants
Stenotic Complications Rate: Meatal Stenosis 6 months	2 Participants	0 Participants
Stenotic Complications Rate: Meatal Stenosis 12 months	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Stenotic Complications Rate: Urethral Stricture 1 month	0 Participants	0 Participants
Stenotic Complications Rate: Urethral Stricture 3 months	2 Participants	1 Participants
Stenotic Complications Rate: Urethral Stricture 6 months	2 Participants	2 Participants
Stenotic Complications Rate: Urethral Stricture 12 months	1 Participants	2 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Stenotic Complications Rate: Bladder Neck Contracture 1 month	0 Participants	0 Participants
Stenotic Complications Rate: Bladder Neck Contracture 3 months	1 Participants	0 Participants
Stenotic Complications Rate: Bladder Neck Contracture 6 months	2 Participants	0 Participants
Stenotic Complications Rate: Bladder Neck Contracture 12 months	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Stress Urinary Incontinence Rate 1 month	18 Participants	12 Participants
Stress Urinary Incontinence Rate 3 months	12 Participants	9 Participants
Stress Urinary Incontinence Rate 6 months	7 Participants	3 Participants
Stress Urinary Incontinence Rate 12 months	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate 1 month	9 Participants	3 Participants
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate 3 months	3 Participants	3 Participants
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate 6 months	3 Participants	2 Participants
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate 12 months	0 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate 1 month	8 Participants	4 Participants
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate 3 months	6 Participants	3 Participants
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate 6 months	6 Participants	4 Participants
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate 12 months	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 12 months

register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Sequelae Rate: Retrograde Ejaculation 1 month	17 Participants	13 Participants
Sequelae Rate: Retrograde Ejaculation 3 months	24 Participants	18 Participants
Sequelae Rate: Retrograde Ejaculation 6 months	21 Participants	17 Participants
Sequelae Rate: Retrograde Ejaculation 12 months	23 Participants	18 Participants

SECONDARY outcome

Timeframe: 12 months

register the number of dysuria at 1, 3, 6, and 12 after surgery.

Outcome measures

Measure	M-TURP n=45 Participants The M-TURP procedure requires the use of a resectoscope (Olympus or Storz, 26Ch), camera system and irrigation fluid (Glycine al 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 Participants 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Sequelae Rate: Dysuria 1 month	5 Participants	0 Participants
Sequelae Rate: Dysuria 3 months	0 Participants	0 Participants
Sequelae Rate: Dysuria 6 months	0 Participants	0 Participants
Sequelae Rate: Dysuria 12 months	0 Participants	0 Participants

Adverse Events

M-TURP

Serious events: 2 serious events

Other events: 4 other events

Deaths: 0 deaths

PK-TURP

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Measure	M-TURP n=45 participants at risk 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 participants at risk 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Renal and urinary disorders Need for reintervention	4.4% 2/45 • 1 year Clavien-Dindo classification	2.6% 1/39 • 1 year Clavien-Dindo classification

Other adverse events

Measure	M-TURP n=45 participants at risk 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP	PK-TURP n=39 participants at risk 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 Transurethral Resection of the Prostate (TURP): Randomized allocation to M-TURP or PK-TURP
Renal and urinary disorders Stenotic events without the need for surgery	8.9% 4/45 • Number of events 4 • 1 year Clavien-Dindo classification	10.3% 4/39 • Number of events 4 • 1 year Clavien-Dindo classification

Additional Information

Dr. Hugo Otaola Arca

Hospital Universitario Fuenlabrada

Phone: +56 9 4108 9452

Email: hugotaolarca@hotmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place