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

Hospital Universitario de Fuenlabrada

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03936244

HUF

Details and patient eligibility

About

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

Full 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)

Enrollment: 100 patients

Sex: Male

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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100 participants in 2 patient groups

M-TURP

Active Comparator group

Description:

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

Treatment:

Device: Transurethral Resection of the Prostate (TURP)

PK-TURP

Experimental group

Description:

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

Treatment:

Device: Transurethral Resection of the Prostate (TURP)