This study will compare voiding assessment based on a minimum spontaneous voided volume of 150 cc with the standard retrograde fill approach in women after pelvic floor procedures.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
110
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Yale University
New Haven, Connecticut, United States
Failure rate
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
Time frame: Up to 2 days post op
False pass rate
The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty .
Time frame: up to 30 days after discharge.
Force of stream (FOS)
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
Time frame: Up to 2 days post op.
Force of stream (FOS)
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-method used
This question asks "How satisfied were you with the method we used to evaluate how well you could urinate after our surgery?" It is measured on a continuum from 0 (very dissatisfied) to 100 (very satisfied).
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions
This question asks "Did you experience any negative emotions such as fear or anxiety when we were evaluating urination after our surgery?" It is measured on a continuum from 0 (many negative emotions) to 100 (no negative emotions).
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-recommend method
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This question asks "How likely would you be to recommend to a friend or family member, the method we used to evaluate your urination after our surgery, if they were in the same situation?" It is measured on a continuum from 0 (very unlikely) to 100 (very likely).
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method
This question asks "How convenient was the method we used to evaluate your urination after our surgery (e.g. time, ease etc.)? It is measured on a continuum from 0 (very inconvenient) to 100 (very convenient).
Time frame: Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-preferred method
This question asks the patient: "If it was all up to you, which It is measured on a continuum from 0 (strongly prefer backfill before catheter) to 100 (strongly prefer no backfill before catheter removal).
Time frame: Up to 2 days post-surgery.
Postoperative pain score
This outcome is measured by a 10-point visual analog scale where 0= no pain, 10=worst pain you have ever experienced.
Time frame: One day post-surgery.
Urinary tract infection (UTI)
UTI is defined as culture-proven bladder infection or, in the absence of a culture, clinical suspicion of a bladder infection that resulted in treatment.
Time frame: Up to 30 days post surgery.
Post-operative complications
Post-operative complications assessed by medical record review.
Time frame: Up to 30 days post-surgery.
Length of hospital stay
Length of hospital stay assessed by medical record review.
Time frame: Up to 2 days post-surgery.