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

NCT03936244 | Completed Results FDA Device

• 1 other identifier: HUF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms; Transurethral Resection of Prostate

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (28)

• Quality of Life (QoL): Bother Score Item of the IPSS Questionnaire

  12 months

• Number of Participants Reporting Sexual Activity in the Last Month

  12 months

• International Index of Erectile Function (IIEF-5)

  12 months

• Prostate Volume (PV)

  12 months

• Operative Time

  Up to 24 hours

Study Arms (2)

M-TURP

ACTIVE COMPARATOR

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)

PK-TURP

EXPERIMENTAL

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)

Interventions

Transurethral Resection of the Prostate (TURP) DEVICE

Randomized allocation to M-TURP or PK-TURP

M-TURP; PK-TURP

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Fuenlabrada: lead

Study Sites (1)

Hospital Universitario de Fuenlabrada

Fuenlabrada, Madrid, 28942, Spain

Location

Related Publications (3)

• 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.

  PMID: 20825758 BACKGROUND

• 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.

  PMID: 24972732 BACKGROUND

• 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.

  PMID: 33047918 RESULT

MeSH Terms

Conditions

Prostatic Hyperplasia; Lower Urinary Tract Symptoms

Interventions

Transurethral Resection of Prostate

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Results Point of Contact

• Title: Dr. Hugo Otaola Arca
• Organization: Hospital Universitario Fuenlabrada

hugotaolarca@hotmail.com

+56 9 4108 9452

Study Officials

• Manuel Álvarez Ardura, M.D.

  Hospital Universitario de Fuenlabrada

  PRINCIPAL INVESTIGATOR

• Hugo Otaola Arca, M.D., Ph.D.

  Hospital Universitario de Fuenlabrada

  PRINCIPAL INVESTIGATOR

• Álvaro Páez Borda, M.D., Ph.D.

  Hospital Universitario de Fuenlabrada

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: April 24, 2019
• First Posted: May 3, 2019
• Study Start: December 5, 2014
• Primary Completion: December 12, 2017
• Study Completion: December 12, 2019
• Last Updated: November 12, 2020
• Results First Posted: October 19, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)