Electronic Catheter Stethoscope

University of South Florida

Status: Completed

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

Study type: Observational

Funder types: Other

Identifiers

NCT01463462

USF IRB 00001841

Details and patient eligibility

About

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.

Enrollment: 75 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

75 participants in 1 patient group

Electronic Catheter Stethoscope