Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Daniel Stephan Engeler

Status: Completed

Conditions: Neoplasm of Lateral Wall of Urinary Bladder

Treatments: Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole); Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)

Study type: Interventional

Funder types: Other

Identifiers

NCT01446822

URO-OBT-01

Details and patient eligibility

About

This is a single-center, prospective, randomized, controlled trial comparing two established transurethral electrical resection methods of urinary bladder tumors regarding their risk of stimulating the obturator nerve.

One of the major safety issues with transurethral resection is bladder perforation as a consequence of obturator nerve stimulation followed by muscle contraction of. This is mostly a risk of resection of lateral bladder wall tumors near the course of the obturator nerve. It has been advocated that bipolar may be superior to monopolar resection, based on its different electrical properties. This is an important safety aspect for the patient.

Main study question: In patients with lateral wall urinary bladder tumors, is bipolar superior to monopolar transurethral electroresection regarding risk of stimulation of the obturator nerve without preoperative nerve block?

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
• operability given based on general medical condition
• informed consent

Exclusion criteria

• antiplatelet drugs stopped <7days (except acetylsalicylate <= 100mg p.o. qd)
• prothrombine time <70%
• age <18 years
• patronized Patients
• pregnancy
• severe poor medical condition

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Bipolar transurethral resection

Experimental group

Treatment:

Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)

Monopolar transurethral resection

Active Comparator group

Treatment:

Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)