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

Not Applicable

Completed

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

Interventions: Device: Transurethral Resection of the Prostate (TURP)

Registration Number: NCT03936244

Lead Sponsor: Hospital Universitario de Fuenlabrada

Brief Summary: 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: 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)

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 100

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PK-TURP	Transurethral Resection of the Prostate (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
M-TURP	Transurethral Resection of the Prostate (TURP)	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

Primary Outcome Measures

Name	Time	Method
Postvoid Residual Urine (PVRU) Volume	12 months	Postvoid residual urine volume (mL) was measured by abdominal ultrasound after urination at 1, 3, 6, and 12 months after surgery.
International Prostate Symptom Score (IPSS)	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
Maximum Urinary Flow Rate (Qmax	12 months	Maximum urinary flow rate (mL/s) at 1, 3, 6, and 12 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Number of Participants Reporting Sexual Activity in the Last Month	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.
Operative Time	Up to 24 hours	Operative time (min)
Hospital Stay	1 month	Hospital stay (days)
Catheter Duration	1 month	Catheter duration (days)
Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire	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
International Index of Erectile Function (IIEF-5)	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
Prostate Volume (PV)	12 months	Prostate volume was measured by transrectal ultrasound at 12 months after surgery
Irrigation Volume	Up to 24 hours	Irrigation volume (L)
Change in Plasmatic Sodium in 24 Hours Post-operation	24 hours after surgery	Compared with the baseline, to demonstrate the sodium loss during operation
Change in Haemoglobin in 24 Hours Post-operation	24 hours after surgery	Compared with the baseline, to demonstrate the blood loss during operation
Transfusion Rate	1 month	Number of participants requiring blood transfusion during, expressed in %
Resected Tissue Weigh	Up to 24 hours	Resected tissue weigh (grams)
Speed Resection	Up to 24 hours	Speed resection (g/min)
Sequelae Rate: Retrograde Ejaculation	12 months	register the number of retrograde ejaculation at 1, 3, 6, and 12 after surgery.
Resected Tissue Percentage	Up to 24 hours	Compared with the baseline, to demonstrate the % of tissue loss during operation
Late Reoperation Rate	12 months	The ratio of patient who need reoperation because residual adenoma or complications
Early Reoperation Rate	1 month	The ratio of patient who need reoperation because bleeding complications
Post-TURP Syndrome Rate	Up to 24 hours	Post-transurethral resection of the prostate syndrome rate was recorded.
Clavien Dindo System	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
Bleeding Complications Rate	1 month	Register the number of events of haematuria and acute urinary retention by clots
Urinary Tract Infections Rate	12 months	Register the number of urinary tract infections at 1, 3, 6, and 12 months after surgery.
Stenotic Complications Rate: Meatal Stenosis	12 months	Register the number of meatal stenosis at 1, 3, 6, and 12 after surgery.
Stenotic Complications Rate: Urethral Stricture	12 months	Register the number of urethral stricture at 1, 3, 6, and 12 after surgery.
Urge Urinary Incontinence With Need for Drug Use (UUIND) Rate	12 months	Register the number of patients with urge urinary incontinence with need for drug use at 1, 3, 6, and 12 after surgery.
Urge Urinary Incontinence Without Need for Drug Use (UUIWND) Rate	12 months	Register the number of patients with urge urinary incontinence without need for drug use at 1, 3, 6, and 12 after surgery.
Sequelae Rate: Dysuria	12 months	register the number of dysuria at 1, 3, 6, and 12 after surgery.
Stenotic Complications Rate: Bladder Neck Contracture	12 months	Register the number of bladder neck contracture at 1, 3, 6, and 12 after surgery.
Stress Urinary Incontinence Rate	12 months	Register the number of patients with stress urinary incontinence at 1, 3, 6, and 12 after surgery.