Voiding Assessment Based on Minimum Spontaneous Void of 150 mL Compared to Retrograde Fill Method After Female Pelvic Floor Reconstructive Surgery
1 other identifier
interventional
110
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 15, 2018
CompletedFirst Posted
Study publicly available on registry
May 29, 2018
CompletedStudy Start
First participant enrolled
September 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 20, 2019
CompletedJanuary 13, 2020
January 1, 2020
4 months
May 15, 2018
January 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Failure rate
The percentage of subjects who did not meet the required voiding assessment criteria and needed catheterization .
Up to 2 days post op
Secondary Outcomes (12)
False pass rate
up to 30 days after discharge.
Force of stream (FOS)
Up to 2 days post op.
Force of stream (FOS)
Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-method used
Up to 2 days post-surgery.
Patient Satisfaction Questionnaire for Voiding Assessment-negative emotions
Up to 2 days post-surgery.
- +7 more secondary outcomes
Study Arms (2)
Spontaneous void
EXPERIMENTALSubjects will not have retrograde fill of bladder, rather will be required to void 150 mL spontaneously prior to discharge.
Retrograde bladder fill
ACTIVE COMPARATORSubjects will have their bladder retrograde filled with 300mL of fluid prior to a voiding trial.
Interventions
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.
Eligibility Criteria
You may qualify if:
- All 18-year-old or older women who undergo surgery for urinary incontinence and/or pelvic organ prolapse (POP)
You may not qualify if:
- Patients who require prolonged Foley catheter or suprapubic catheter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Yale Universitylead
Study Sites (1)
Yale University
New Haven, Connecticut, 06510, United States
Related Publications (1)
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.
PMID: 34184246DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Harmanli Oz, MD
Yale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 15, 2018
First Posted
May 29, 2018
Study Start
September 1, 2019
Primary Completion
December 20, 2019
Study Completion
December 20, 2019
Last Updated
January 13, 2020
Record last verified: 2020-01