Back to resultsVoiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
Primary Purpose
Urinary Incontinence, Pelvic Organ Prolapse
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Retrograde bladder fill
spontaneous void
Sponsored by
About this trial
This is an interventional supportive care trial for Urinary Incontinence
Eligibility Criteria
Inclusion Criteria:
- All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
Exclusion Criteria:
- Patients who require prolonged Foley catheter or suprapubic catheter
Sites / Locations
- Yale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Spontaneous void
Retrograde bladder fill
Arm Description
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Outcomes
Primary Outcome Measures
Failure rate
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
Secondary Outcome Measures
False pass rate
The percentage of women who initially met the voiding assessment but returned for re-catheterization due to voiding difficulty .
Force of stream (FOS)
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
Force of stream (FOS)
Patient reported force of stream (FOS) during voiding; (0 being no urination, 10 being normal strong flow).
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).
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).
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).
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).
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).
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.
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.
Post-operative complications
Post-operative complications assessed by medical record review.
Length of hospital stay
Length of hospital stay assessed by medical record review.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03539107
Brief Title
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
Official Title
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
December 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urinary Incontinence, Pelvic Organ Prolapse
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Spontaneous void
Arm Type
Experimental
Arm Description
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Arm Title
Retrograde bladder fill
Arm Type
Active Comparator
Arm Description
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Intervention Type
Procedure
Intervention Name(s)
Retrograde bladder fill
Intervention Description
Subjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Intervention Type
Other
Intervention Name(s)
spontaneous void
Intervention Description
Subjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Primary Outcome Measure Information:
Title
Failure rate
Description
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
Time Frame
Up to 2 days post op
Secondary Outcome Measure Information:
Title
False pass rate
Description
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.
Title
Force of stream (FOS)
Description
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.
Title
Force of stream (FOS)
Description
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.
Title
Patient Satisfaction Questionnaire for Voiding Assessment-method used
Description
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.
Title
Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions
Description
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.
Title
Patient Satisfaction Questionnaire for Voiding Assessment-recommend method
Description
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.
Title
Patient Satisfaction Questionnaire for Voiding Assessment-convenience of method
Description
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.
Title
Patient Satisfaction Questionnaire for Voiding Assessment-preferred method
Description
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.
Title
Postoperative pain score
Description
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.
Title
Urinary tract infection (UTI)
Description
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.
Title
Post-operative complications
Description
Post-operative complications assessed by medical record review.
Time Frame
Up to 30 days post-surgery.
Title
Length of hospital stay
Description
Length of hospital stay assessed by medical record review.
Time Frame
Up to 2 days post-surgery.
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
Exclusion Criteria:
Patients who require prolonged Foley catheter or suprapubic catheter
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmanli Oz, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
34184246
Citation
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
Results Reference
derived
Learn more about this trial
Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
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