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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.
Condition or disease
Pelvic Organ ProlapseGynecologic CancersUterine LeiomyomataAdenomyosisEndometrial HyperplasiaOther Abnormal Uterine and Vaginal BleedingPelvic MassPelvic Pain
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 Outcome Measures :
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) ]
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Layout table for eligibility information
Ages Eligible for Study:
18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Current patients having gynecological surgery
age 18 or older
plan to have one of the following types of surgery:
laparoscopic or abdominal gynecological surgery
able to provide written informed consent
under 18 years of age
bilateral tubal ligation as the single reason for surgery