Electrical Evaluation of Urinary BladderNCT02041442
Electrophysiologic Mapping of the Bladder
A study testing Electrical mapping of the urinary bladder in people with Electrical Evaluation of Urinary Bladder, run by Englewood Hospital and Medical Center at 1 site in United States.
Trial summary
The hypothesis is that the intrinsic electrical activity of the urinary bladder in response to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility of using cardiac electrical mapping catheters to measure bladder voltage in patients at the time of routine urodynamic and… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Electrical Evaluation of Urinary Bladder
- What is being tested?
- Electrical mapping of the urinary bladder
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Jun 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is a female > = 18 years old.
- Subject is willing and able to provide informed consent.
- Subject has subjective and objective evidence for urinary urgency (with or without incontinence), stress incontinence, or mixed incontinence (with features of both urgency and stress).
- Subject requires urodynamic/cystoscopic studies to complete their workup.
Who cannot join
- Active urinary tract infection
- Pregnant women
- Patients on anticholinergic medicine for overactive bladder
- Patients with history of intravesical botulinum toxin injections
- Patients with a sacral neuromodulator implant
- Patients with a history of urinary tract malignancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Englewood Hospital and Medical Center
Englewood, New Jersey, 07631
About this study
Official title: Pilot of Electrophysiologic Mapping of the Urinary Bladder
The hypothesis is that the intrinsic electrical activity of the urinary bladder in response to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility of using cardiac electrical mapping catheters to measure bladder voltage in patients at the time of routine urodynamic and cystoscopic evaluation.
Read the detailed description
This pilot study is looking at the possibility of adapting some of the tools and techniques used by cardiac electrophysiologists (doctors specializing in the electrical activity of the heart) to help diagnose and treat Overactive Bladder. The rationale for this approach is based on the similarities of the two organs. In simple terms, the heart and bladder are both hollow muscular organs that expand and contract to hold and move fluid.
In an electrophysiology study looking at cardiac (heart) arrhythmia (irregular heartbeat), the cardiologist places one or more electrode catheters (thin hollow tube with an electrical conductor on the end) through a vein or artery in the leg or arm to contact heart tissue. By recording the electrical activity at multiple sites of the heart, the catheter allows for mapping of the electrical activity and the arrhythmia mechanism.
In this study, investigators will use the same electrode catheter to contact bladder tissue, introduce a low frequency current, and map the electrical activity of the bladder. A sterile cardiac electrical mapping catheter will be used to make contact with the walls of the bladder and introduce a low frequency current starting with the trigone and then the four quadrants of the dome. Electrical activity will be recorded for each volumetric milestone at each location. It is hoped that the information from this electrophysiological testing of the bladder may eventually lead to treatment of areas of electrical abnormality of interest. No actual treatment of the bladder will be done as part of this pilot study.
- Conditions
- Electrical Evaluation of Urinary Bladder
- Being tested
- Electrical mapping of the urinary bladder
- Keywords
- overactive bladder, cystoscopy
- Medical subject headings
- Urinary Bladder, Overactive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electrical mapping of the urinary bladderProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| All subjects | Experimental | Electrical mapping of the urinary bladder Receives: Procedure: Electrical mapping of the urinary bladder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in electrical activity
goal of this pilot study is to determine whether electrical activity can be recorded from different areas of the bladder using cardiac surface electrodes
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 posted22 Jan 2014 (estimated)
- Study startMar 2014
- Primary completionJun 2016
- Study completionJun 2016
Why it stopped: study to be redesigned based on initial results
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Electrical Evaluation 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Englewood Hospital and Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Vardy, MD, Principal investigator, Englewood Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02041442
- Sponsor's protocol ID
- E-13-529
- Status last verified
- Jun 2016
- First submitted
- 16 Jan 2014
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot of Electrophysiologic Mapping of the Urinary Bladder
- ClinicalTrials.gov ID
- NCT02041442
- Acronym / sponsor ID
- E-13-529
- Conditions
- Electrical Evaluation of Urinary Bladder
- Keywords
- overactive bladder, cystoscopy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: study to be redesigned based on initial results
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Englewood Hospital and Medical CenterUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 22 Jan 2014 (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.
The hypothesis is that the intrinsic electrical activity of the urinary bladder in response to filling is detectable and can be mapped. This is a pilot study to evaluate the feasibility of using cardiac electrical mapping catheters to measure bladder voltage in patients at the time of routine urodynamic and cystoscopic evaluation.
Detailed description
This pilot study is looking at the possibility of adapting some of the tools and techniques used by cardiac electrophysiologists (doctors specializing in the electrical activity of the heart) to help diagnose and treat Overactive Bladder. The rationale for this approach is based on the similarities of the two organs. In simple terms, the heart and bladder are both hollow muscular organs that expand and contract to hold and move fluid.
In an electrophysiology study looking at cardiac (heart) arrhythmia (irregular heartbeat), the cardiologist places one or more electrode catheters (thin hollow tube with an electrical conductor on the end) through a vein or artery in the leg or arm to contact heart tissue. By recording the electrical activity at multiple sites of the heart, the catheter allows for mapping of the electrical activity and the arrhythmia mechanism.
In this study, investigators will use the same electrode catheter to contact bladder tissue, introduce a low frequency current, and map the electrical activity of the bladder. A sterile cardiac electrical mapping catheter will be used to make contact with the walls of the bladder and introduce a low frequency current starting with the trigone and then the four quadrants of the dome. Electrical activity will be recorded for each volumetric milestone at each location. It is hoped that the information from this electrophysiological testing of the bladder may eventually lead to treatment of areas of electrical abnormality of interest. No actual treatment of the bladder will be done as part of this pilot study.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All subjects | Experimental | Procedure: Electrical mapping of the urinary bladderElectrical mapping of the urinary bladder |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is a female > = 18 years old.
- Subject is willing and able to provide informed consent.
- Subject has subjective and objective evidence for urinary urgency (with or without incontinence), stress incontinence, or mixed incontinence (with features of both urgency and stress).
- Subject requires urodynamic/cystoscopic studies to complete their workup.
Key exclusion criteria (6 listed)
- Active urinary tract infection
- Pregnant women
- Patients on anticholinergic medicine for overactive bladder
- Patients with history of intravesical botulinum toxin injections
- Patients with a sacral neuromodulator implant
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 |
|---|---|---|
| Electrical mapping of the urinary bladder | Procedure or surgery | All subjects |
Primary outcome
Change in electrical activity
Time frame: 3 months
goal of this pilot study is to determine whether electrical activity can be recorded from different areas of the bladder using cardiac surface electrodes
Results and safety
The study was stopped early (reason given: study to be redesigned based on initial results). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Related InfoLink provided by the sponsor.
Related trials for Electrical Evaluation of Urinary Bladder
Recruiting
Evaluation of a Non-Implanted Electrical Stimulation Device for Overactive Bladder (OAB)
Overactive Bladder (OAB)
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.
Michael Vardy, MD principal investigator
Englewood Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electrical mapping of the urinary bladder in people with Electrical Evaluation of Urinary Bladder, run by Englewood Hospital and Medical Center at 1 site in United States.
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 4 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: stopped early, as of the sponsor's last update on 3 Jun 2016. 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 United States. 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 was stopped early (reason given: study to be redesigned based on initial results). Results are not available in the source record.
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?
Change in electrical activity (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jun 2016.