NCT02041442

Brief 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 cystoscopic evaluation.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2014

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 22, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2016

Completed
Last Updated

June 3, 2016

Status Verified

June 1, 2016

Enrollment Period

2.3 years

First QC Date

January 16, 2014

Last Update Submit

June 2, 2016

Conditions

Electrical Evaluation of Urinary Bladder

Keywords

overactive bladdercystoscopy

Outcome Measures

Primary Outcomes (1)

  • 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

    3 months

Study Arms (1)

All subjects

EXPERIMENTAL

Electrical mapping of the urinary bladder

Procedure: Electrical mapping of the urinary bladder

Interventions

Electrical mapping of the urinary bladderPROCEDURE
All subjects

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Englewood Hospital and Medical Center

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Conditions

Urinary Bladder, Overactive

Condition Hierarchy (Ancestors)

Urinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Michael Vardy, MD

    Englewood Hospital and Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 16, 2014

First Posted

January 22, 2014

Study Start

March 1, 2014

Primary Completion

June 1, 2016

Study Completion

June 1, 2016

Last Updated

June 3, 2016

Record last verified: 2016-06

Locations

US(1)