Electronic Catheter Stethoscope

Sponsor

University of South Florida (Other)

Overall Status

Completed

CT.gov ID

NCT01463462

Collaborator

(none)

Enrollment

Location

Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is an observational, exploratory study designed to collect (record) and analyze normal and abnormal sound data from the human bladder during surgery using a novel sensor-based catheter system (Electronic Catheter Stethoscope) and to develop algorithms to detect changes of baseline bladder and ureteral function. The Electronic Catheter Stethoscope device will measure acoustic and pressure data within the bladder. The measurements will be used to detect any leakage from the bladder and/or changes in baseline ureteral flow by correlation of sound data with surgical data reported by the surgeon. These data will be used to develop algorithms to detect changes of baseline bladder and ureteral function. The algorithms will be tested in future clinical trials.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse Gynecologic Cancers Uterine Leiomyomata Adenomyosis Endometrial Hyperplasia Other Abnormal Uterine and Vaginal Bleeding Pelvic Mass Pelvic Pain

Study Design

Study Type:

Observational

Actual Enrollment :

75 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Use of the Electronic Catheter Stethoscope for the Detection of Urinary Tract Injury During Gynecologic Surgery

Study Start Date :

Feb 1, 2011

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

Apr 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Electronic Catheter Stethoscope

Outcome Measures

Primary Outcome Measures

bladder and ureter sounds during pelvic surgery. [from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)]

Secondary Outcome Measures

changes from baseline bladder and ureteral function sounds [from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)]