Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery

Not Applicable

Completed

• Conditions: Urinary Incontinence; Pelvic Organ Prolapse
• Interventions: Procedure: Retrograde bladder fill; Other: spontaneous void

• Registration Number: NCT03539107
• Lead Sponsor: Yale University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-15
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Study Start: 2019-09-01
• Primary Completion: 2019-12-20
• Study Completion: 2019-12-20
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 110

Inclusion Criteria

• All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)

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Exclusion Criteria

• Patients who require prolonged Foley catheter or suprapubic catheter

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Retrograde bladder fill	Retrograde bladder fill	Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Spontaneous void	spontaneous void	Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.

Primary Outcome Measures

Name	Time	Method
Failure rate	Up to 2 days post op	The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .

Secondary Outcome Measures

Name	Time	Method
Patient Satisfaction Questionnaire for Voiding Assessment-method used	Up to 2 days post-surgery.	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).
Force of stream (FOS)	Up to 2 days post-surgery.	Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
False pass rate	up to 30 days after discharge.	The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty .
Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions	Up to 2 days post-surgery.	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).
Patient Satisfaction Questionnaire for Voiding Assessment-preferred method	Up to 2 days post-surgery.	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).
Urinary tract infection (UTI)	Up to 30 days post surgery.	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.
Length of hospital stay	Up to 2 days post-surgery.	Length of hospital stay assessed by medical record review.
Patient Satisfaction Questionnaire for Voiding Assessment-recommend method	Up to 2 days post-surgery.	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).
Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method	Up to 2 days post-surgery.	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).
Postoperative pain score	One day post-surgery.	This outcome is measured by a 10-point visual analog scale where 0= no pain, 10=worst pain you have ever experienced.
Post-operative complications	Up to 30 days post-surgery.	Post-operative complications assessed by medical record review.

Trial Locations

Locations (1)

Yale University; 🇺🇸 New Haven, Connecticut, United States