Electronic Catheter Stethoscope

Completed

• Conditions: Pelvic Mass; Gynecologic Cancers; Pelvic Pain; Pelvic Organ Prolapse; Uterine Leiomyomata; Adenomyosis; Endometrial Hyperplasia; Other Abnormal Uterine and Vaginal Bleeding

• Registration Number: NCT01463462
• Lead Sponsor: University of South Florida

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-28
• Study First Posted: 2011-11-02
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-26
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Women's Center Operating Rooms at the Tampa General Hospital; 🇺🇸 Tampa, Florida, United States