Neoplasm of Lateral Wall of Urinary BladderNCT01446822
Safety Study of Bipolar Versus Monopolar Transurethral Resection of Bladder Tumors
A study testing Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) and Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) in people with Neoplasm of Lateral Wall of Urinary Bladder, run by Daniel Stephan Engeler at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neoplasm of Lateral Wall of Urinary Bladder
- What is being tested?
- Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) and Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- Oct 2011to Sep 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
- operability given based on general medical condition
- informed consent
Who cannot join
- antiplatelet drugs stopped <7days (except acetylsalicylate <= 100mg p.o. qd)
- prothrombine time <70%
- age <18 years
- patronized Patients
- pregnancy
- severe poor medical condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
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?
- Being tested
- Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius), Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)
- Keywords
- urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve
- Medical subject headings
- Urinary Bladder Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)Device
Also called PlasmaKinetic resectoscope, Gyrus PlasmaKinetic SuperPulse generator (Gyrus Medical Inc., Maple Grove, USA), Fresenius Natriumchlorid 9,0g/l (Fresenius Kabi AG, Homburg, Germany)
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.
Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)Device
Also called Resectoscope Model 27050 (Karl Storz GmbH & Co. KG, Tuttlingen, Germany), Erbotom ICC 350 (Deltamed-ERBE AG,Winterthur, Switzerland), Purisole®SM (Fresenius Kabi AG, Homburg, Germany)
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 group | Role | What they receive |
|---|---|---|
| Bipolar transurethral resection | Experimental | Not described Receives: Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) |
| Monopolar transurethral resection | Active comparator | Not described Receives: Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful resection of bladder tumor
Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles
Measured: Intraoperative
Secondary outcomes (1)
Complications
Degree of severity of the complications (perforation of the bladder, intraoperative bleeding, postoperative bleeding, others) according to the Clavien-classification
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2011 (estimated)
- Study startOct 2011
- Primary completionJun 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neoplasm of Lateral Wall of Urinary BladderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniel Stephan Engeler
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniel Stephan Engeler, Cantonal Hospital of St. Gallen
- Investigators
- Daniel S Engeler, MD, Study chair, Cantonal Hospital of St. Gallen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01446822
- Sponsor's protocol ID
- URO-OBT-01
- Status last verified
- Mar 2018
- First submitted
- 3 Oct 2011
- Last updated
- 5 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Gramann T, Schwab C, Zumstein V, Betschart P, Meier M, Schmid HP, Engeler DS. Transurethral resection of bladder cancer on the lateral bladder wall without obturator nerve block: extent of adductor spasms using the monopolar versus bipolar technique-a prospective randomised study. World J Urol. 2018 Jul;36(7):1085-1091. doi: 10.1007/s00345-018-2248-0. Epub 2018 Mar 1.
PubMed 29497859
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transurethral Resection of Bladder Tumors Without Obturator Nerve Block or Relaxation: Extent of Adductor Muscle Contraction With Monopolar Versus Bipolar Resection Technique
- ClinicalTrials.gov ID
- NCT01446822
- Acronym / sponsor ID
- URO-OBT-01
- Keywords
- urinary bladder neoplasm, bipolar transurethral resection, monopolar transurethral resection, obturator nerve
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Daniel Stephan EngelerUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jun 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 5 Oct 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bipolar transurethral resection | Experimental | Device: Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) |
| Monopolar transurethral resection | Active comparator | Device: Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- neoplasms of the lateral wall of the urinary bladder (laterally to the corresponding ostium)
- operability given based on general medical condition
- informed consent
Key exclusion criteria (6 listed)
- antiplatelet drugs stopped <7days (except acetylsalicylate <= 100mg p.o. qd)
- prothrombine time <70%
- age <18 years
- patronized Patients
- pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius)Also: PlasmaKinetic resectoscope, Gyrus PlasmaKinetic SuperPulse generator (Gyrus Medical Inc., Maple Grove, USA), Fresenius Natriumchlorid 9,0g/l (Fresenius Kabi AG, Homburg, Germany)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. | Device | Bipolar transurethral resection |
| Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole)Also: Resectoscope Model 27050 (Karl Storz GmbH & Co. KG, Tuttlingen, Germany), Erbotom ICC 350 (Deltamed-ERBE AG,Winterthur, Switzerland), Purisole®SM (Fresenius Kabi AG, Homburg, Germany)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. | Device | Monopolar transurethral resection |
Primary outcome
Successful resection of bladder tumor
Time frame: Intraoperative
Successful resection of the neoplasm without relevant stimulation of the obturator nerve and consecutive contraction of the ipsilateral adductor muscles
1 secondary outcome
Complications
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2018.
- Results publication: PubMed 29497859Gramann T, Schwab C, Zumstein V, Betschart P, Meier M, Schmid HP, Engeler DS. Transurethral resection of bladder cancer on the lateral bladder wall without obturator nerve block: extent of adductor spasms using the monopolar versus bipolar technique-a prospective randomised study. World J Urol. 2018 Jul;36(7):1085-1091. doi: 10.1007/s00345-018-2248-0. Epub 2018 Mar 1.
- Full text view of publication in World Journal of UrologyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daniel S Engeler, MD study chair
Cantonal Hospital of St. Gallen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bipolar transurethral resection of the urinary bladder (PlasmaKinetic, Gyrus, Fresenius) and Monopolar transurethral resection of the urinary bladder (Storz GmbH &Co., Erbotom, Purisole) in people with Neoplasm of Lateral Wall of Urinary Bladder, run by Daniel Stephan Engeler at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Successful resection of bladder tumor (time frame: Intraoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01446822, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Mar 2018.