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

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

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

Study Overview

• Status: Completed
• Conditions: Lower Urinary Tract Symptoms; Prostatic Hyperplasia; Transurethral Resection of Prostate
• Intervention / Treatment: Device: Transurethral Resection of the Prostate (TURP)

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)

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Fuenlabrada, Madrid, Spain, 28942
      • Hospital Universitario de Fuenlabrada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: M-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	Device: Transurethral Resection of the Prostate (TURP); Randomized allocation to M-TURP or PK-TURP
Experimental: 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	Device: Transurethral Resection of the Prostate (TURP); Randomized allocation to M-TURP or PK-TURP

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital Universitario de Fuenlabrada
• Investigators: Principal Investigator: Manuel Álvarez Ardura, M.D., Hospital Universitario de Fuenlabrada; Principal Investigator: Hugo Otaola Arca, M.D., Ph.D., Hospital Universitario de Fuenlabrada; Study Chair: Álvaro Páez Borda, M.D., Ph.D., Hospital Universitario de Fuenlabrada

Publications and helpful links

General Publications

• Cornu JN, Ahyai S, Bachmann A, de la Rosette J, Gilling P, Gratzke C, McVary K, Novara G, Woo H, Madersbacher S. A Systematic Review and Meta-analysis of Functional Outcomes and Complications Following Transurethral Procedures for Lower Urinary Tract Symptoms Resulting from Benign Prostatic Obstruction: An Update. Eur Urol. 2015 Jun;67(6):1066-1096. doi: 10.1016/j.eururo.2014.06.017. Epub 2014 Jun 25.
• Ahyai SA, Gilling P, Kaplan SA, Kuntz RM, Madersbacher S, Montorsi F, Speakman MJ, Stief CG. Meta-analysis of functional outcomes and complications following transurethral procedures for lower urinary tract symptoms resulting from benign prostatic enlargement. Eur Urol. 2010 Sep;58(3):384-97. doi: 10.1016/j.eururo.2010.06.005. Epub 2010 Jun 11.
• Otaola-Arca H, Alvarez-Ardura M, Molina-Escudero R, Fernandez MI, Paez-Borda A. A prospective randomized study comparing bipolar plasmakinetic transurethral resection of the prostate and monopolar transurethral resection of the prostate for the treatment of Benign Prostatic Hyperplasia: efficacy, sexual function, Quality of Life, and complications. Int Braz J Urol. 2021 Jan-Feb;47(1):131-144. doi: 10.1590/S1677-5538.IBJU.2019.0766.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2014
• Primary Completion (Actual): December 12, 2017
• Study Completion (Actual): December 12, 2019

Study Registration Dates

• First Submitted: April 24, 2019
• First Submitted That Met QC Criteria: April 30, 2019
• First Posted (Actual): May 3, 2019

Study Record Updates

• Last Update Posted (Actual): November 12, 2020
• Last Update Submitted That Met QC Criteria: October 19, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Urological Manifestations; Prostatic Diseases; Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
• Other Study ID Numbers: HUF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes