An interventional study of Retrograde bladder fill and spontaneous void in Urinary Incontinence and Pelvic Organ Prolapse, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-01-13.
Sponsored by Yale University · Not applicable, Interventional, and Supportive care
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.
1,363 studies on the registry are indexed under Urinary Incontinence; 228 are open to participants now.
This study's enrollment of 110 is above the median of 66 across 1,011 interventional studies indexed under Urinary Incontinence.
Browse Urinary Incontinence studies →Yale University is the lead sponsor of 1,724 studies on the registry; 298 are open to participants now.
Of its 210 completed or terminated interventional studies of FDA-regulated products, 126 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Other: spontaneous void
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Procedure: Retrograde bladder fill
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.
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
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.
This study is completed, as verified in Jan 2020. You cannot join it, but the record below documents what was studied.
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Yale University