Electronic Catheter Stethoscope

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

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 75

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33606
      • Women's Center Operating Rooms at the Tampa General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Current patients having gynecological surgery

Description

Inclusion Criteria

• age 18 or older

• plan to have one of the following types of surgery:

  • laparoscopic or abdominal gynecological surgery
  • vaginal surgery
• able to provide written informed consent

Exclusion Criteria

• under 18 years of age
• bilateral tubal ligation as the single reason for surgery
• current pregnancy
• unable to provide written informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Electronic Catheter Stethoscope

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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)

Collaborators and Investigators

• Sponsor: University of South Florida
• Investigators: Principal Investigator: Stuart Hart, MD, University of South Florida

Study record dates

Study Major Dates

• Study Start: February 1, 2011
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: October 19, 2011
• First Submitted That Met QC Criteria: October 28, 2011
• First Posted (Estimate): November 2, 2011

Study Record Updates

• Last Update Posted (Estimate): May 27, 2016
• Last Update Submitted That Met QC Criteria: May 26, 2016
• Last Verified: May 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type; Neoplasms; Pain; Neurologic Manifestations; Uterine Diseases; Hemorrhage; Connective Tissue Diseases; Pathological Conditions, Anatomical; Neoplasms, Connective Tissue; Neoplasms, Muscle Tissue; Hyperplasia; Endometrial Hyperplasia; Prolapse; Pelvic Organ Prolapse; Adenomyosis; Leiomyoma; Myofibroma; Pelvic Pain; Uterine Hemorrhage
• Other Study ID Numbers: USF IRB 00001841