Electronic Catheter Stethoscope

Pelvic Organ Prolapse Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01463462
• Other study ID #: USF IRB 00001841
• Status: Completed
• Phase: N/A
• First received: October 19, 2011
• Last updated: May 26, 2016
• Start date: February 2011
• Est. completion date: April 2016

Study information

• Verified date: May 2016
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Women's Center Operating Rooms at the Tampa General Hospital	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of South Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	Yes
Secondary	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)	Yes