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
Phase: NA
Conditions: Prostatic Hyperplasia, Lower Urinary Tract Symptoms, Transurethral Resection of Prostate
Sponsor: Hospital Universitario de Fuenlabrada

 
 
STUDY PROTOCOL 
 
 
 
Bipolar Plasmakinetic TURP Versus Monopolar TURP in the 
Treatment of Lower Urinary Tract Symptoms (LUTS) Due to 
Benign Prostatic Hyperplasia (BPH) 
 
 
NCT number: NCT03936244 
 
 
Date: December 12, 2019 
 

Patients 
Men clinically diagnosed with LUTS in a tertiary-care public institution and 
who required surgical treatment were invited to participate in the study from 
December 2014 to August 2016. Inclusion criteria were prostate volume (PV) 
<80g on transrectal ultrasound (TRUS) with LUTS due to drug-refractory BPH or 
complications derived from BPH (acute urinary retention (AUR), recurrent 
hematuria, recurrent urinary tract infection (UTI) or bladder calculi) or both. 
Patients with a previous history of pelvic surgery or radiotherapy, neurogenic 
bladder dysfunction, or prostate carcinoma were excluded. 
 
Randomized group assignment was ensured by using a table of aleatory 
numbers. Only patients who were willing to continue participating in the trial after 
surgery, filled all the questionnaires during the follow-up and did not present any 
malignancy requiring additional treatment, were eligible for inclusion in the 
analyses. An intention to treat analysis was conducted and, as usual for surgical 
trials, only patients were blinded to the procedure. Ethical approval of the 
institutional review board (IRB) (APR-14-72) was granted, and informed consent 
was obtained from all subjects. 
 
Study variables 
Baseline characteristics included age, comorbidities, American society of 
anesthesiologists classification (ASA), laboratory values including prostate-
specific antigen (PSA), international prostate symptom score (IPSS), maximum 
urinary flow rate (Qmax), post voiding residual urine (PVRU) volume, PV by 
TRUS, QoL score, sexual activity and international index of erectile function (IIEF-
5). Direct questions were included to evaluate stress urinary incontinence (SUI), 
urge urinary incontinence with or without the need for drug use (UUIND and 
UUIWND), retrograde ejaculation, and dysuria. Drugs for LUTS and hemostasis 
used before surgery were recorded. 
 
Operative outcomes included irrigation volume, operation time (from the first 
cut to catheter placement), changes in serum sodium and hemoglobin, amount 
of resected tissue, speed of resection (dividing resected tissue by operative time), 
length of stay and length of the indwelling catheter. 

 
Intraoperative, perioperative, and postoperative complications and sequelae 
at 1, 3, 6, and 12 months were recorded; when applied, complications were 
classified according to the Clavien-Dindo system (CDS). To measure bleeding, 
the variable hemorrhagic complications (HC) was created by grouping hematuria 
and clot retention. Efficacy outcomes (IPSS, QoL score, Qmax, PVRU volume, 
and PV by TRUS) and sexual function (sexual activity and IIEF-5 questionnaire) 
were recorded for the same periods. 
 
Treatment failure was characterized by the need for a re-TURP (residual 
adenoma), readmission or reoperation, or by recurrent UTI. 
 
Surgical technique 
Patients were operated by residents and senior urologists, as per the usual 
daily practice at our teaching institution. M-TURP was conducted with a 26-Ch 
Olympus/Storz resectoscope under continuous glycine irrigation (1.5% glycine, 
Baxter), using a monopolar stainless-steel loop connected to a ForceTriadTM 
generator (Medtronic) (cutting and coagulation, 120W and 80W). PK-TURP was 
performed with a 26-Ch Storz resectoscope under continuous irrigation with 
saline solution (0.9% NaCl, Baxter), using a bipolar Superloop platinum-iridium 
(Gyrus ACMI) resection loop connected to a Plasma KineticTM Superpulse 
generator (Gyrus-ACMI) (180W and 100W). The irrigation liquid was placed 2 
meters above the ground in all cases, with the surgical table at 80cm from the 
floor. A Neptune 2® (Stryker) continuous aspiration system was used during 
surgery at 80mmHg. Nesbit technique was performed in both groups. All 
procedures were performed under spinal anesthesia. Recovered tissue was 
collected and submitted for pathological exam. At the end of both procedures, a 
22-Ch three-way Foley catheter was placed into the bladder with a closed 
drainage system. Continuous irrigation with saline solution was initiated at the 
end of the procedure and interrupted 24 hours after surgery; the irrigation was 
definitively withdrawn after 4 hours of clear urine (defined as being able to read 
the newspaper headline through the urine collection tube). Patients were 
discharged on the first postoperative day, and the catheter was removed 

ambulatory 72 hours after surgery (if clear urine). Blood tests were performed 
before discharge. 
 
Statistical analysis 
The sample size was calculated to detect differences ≥3 points in the IPSS 
questionnaire. An α-error of 5% and a power of 80% were established. The 
sample size was calculated using the STATA® program, and 20% patient loss 
was assumed during follow-up. Comparisons were conducted using the chi-
square/Fisher test and T-Student/Mann-Whitney test as needed. Statistical 
significance was established at p<0.05 for all analyses. Statistical analysis was 
performed using the IBM-SPSS v23.0 statistics.