Status:
TERMINATED
At Home Early vs. Delayed Catheter Removal Following Failed Postoperative Voiding Trial: a Randomized Trial
Lead Sponsor:
Wake Forest University Health Sciences
Conditions:
Urinary Retention Postoperative
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This study aims to investigate whether patients who self-remove their indwelling transurethral catheters on POD 1 have similar rates of postoperative catheter reinsertion for urinary retention (within...
Detailed Description
Studies estimate the rate of post-operative urinary retention (POUR) after pelvic reconstructive surgery to be between 2.5-43% in all patients1. Consequently, patients undergoing pelvic reconstructive...
Eligibility Criteria
Inclusion
- English speaking Age 18+ Undergoing pelvic reconstructive surgery with ERAS protocol Incomplete bladder emptying after same day VT in PACU (as defined by an ultrasound or straight catheter post void residual of greater than 50% the total instilled volume within 10 minutes following a void postoperatively) Able to complete a telephone appointment on either postoperative day 1 or 3
Exclusion
- Active urinary tract infection, defined by CDC criteria Patients undergoing pelvic reconstructive surgery where ERAS protocol is not utilized (examples: isolated Labiaplasty, chemodenervation with onabotulinum toxin A, urethral bulking, mid-urethral sling, sacral neuromodulation) Contraindication to ERAS protocol and/or its medications Elevated pre-op PVR greater than 200mL (on urodynamic testing or uroflow or straight catheter sample, that remains elevated after prolapse is reduced) Limited manual dexterity (limiting self-removal of catheter) Intra-op cystotomy or urinary tract injury Planned long term catheterization (e.g., fistula repair, urethral diverticulum) Planned hospital admission or patients who are not discharged from hospital the same day of their surgery Pregnancy Dependent on catheterization to void preoperatively Patients who request clean intermittent catheterization (CIC) after immediate failed VT Neurological conditions that affect voiding function (examples: spinal cord lesions, multiple sclerosis, Parkinson's disease, past stroke history with residual neurologic deficits) Concomitant surgical procedure by another service Conversion to open surgery Patients discharged to nursing home or rehabilitation care facility
Key Trial Info
Start Date :
June 29 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 6 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05353400
Start Date
June 29 2022
End Date
April 6 2023
Last Update
May 6 2023
Active Locations (1)
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1
Atrium Health
Charlotte, North Carolina, United States, 28203