Electronic Catheter Stethoscope

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.

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Key information

Conditions

Pelvic Organ Prolapse Adenomyosis Connective Tissue Diseases Endometrial Hyperplasia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Gynecologic Cancers Hemorrhage Myofibroma Neoplasms Neoplasms by Histologic Type Neoplasms, Connective Tissue Neoplasms, Connective and Soft Tissue Neurologic Manifestations Other Abnormal Uterine and Vaginal Bleeding Pain Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Pelvic Mass Pelvic Pain Prolapse Signs and Symptoms Skin and Connective Tissue Diseases Urogenital Diseases Uterine Diseases Uterine Hemorrhage Uterine Leiomyomata

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Women's Center Operating Rooms at the Tampa General Hospital

Tampa, Florida, 33606, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

bladder and ureter sounds during pelvic surgery.

Time frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)

Secondary outcomes

changes from baseline bladder and ureteral function sounds

Time frame: from time of bladder catheter placement and initiation of recording during surgery to completion of pelvic surgery (within 8 hours)

Sponsors and collaborators

Lead sponsor

University of South Florida

Other

Registry information

Official study title

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

Important dates

Study start: 2011
Primary completion: 2016
Study completion: 2016
First posted: Nov 2, 2011
Registry last updated: May 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed