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


N/A
18 Years
N/A
Open (Enrolling)
Female
Pelvic Organ Prolapse, Gynecologic Cancers, Uterine Leiomyomata, Adenomyosis, Endometrial Hyperplasia, Other Abnormal Uterine and Vaginal Bleeding, Pelvic Mass, Pelvic Pain

Thank you

Trial Information

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

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

bladder and ureter sounds during pelvic surgery.

Outcome Time Frame:

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

Safety Issue:

Yes

Principal Investigator

Stuart Hart, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of South Florida

Authority:

United States: Institutional Review Board

Study ID:

USF IRB 00001841

NCT ID:

NCT01463462

Start Date:

February 2011

Completion Date:

Related Keywords:

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

Name

Location
Women's Center Operating Rooms at the Tampa General Hospital Tampa, Florida  33606