Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors

Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01446822

Enrollment

Registered

2011-10-05

Start date

2011-10-31

Completion date

2016-09-30

Last updated

2018-03-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neoplasm of Lateral Wall of Urinary Bladder

Keywords

urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve

Brief summary

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?

Interventions

DEVICEBipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)

Lateral wall urinary bladder tumors are resected transurethrally without obturator nerve block or relaxation under general anesthesia. If resection not possible because of adductor muscle contraction, patients undergo relaxation.

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

Lateral wall urinary bladder tumors are resected transurethrally without obturator nerve block or relaxation under general anesthesia. If resection is not possible because of adductor muscle contraction, patients are treated by bipolar resection. If this is still not possible, they undergo relaxation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Successful resection of bladder tumor	Intraoperative	Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles

Secondary

Measure	Time frame	Description
Complications	3 months	Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification

Countries

Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026