The goal of this randomized clinical trial is to determine if removal of transurethral urinary catheters by patients at home is as safe as catheter removal in the office following urogynecologic surgery. Participants will be randomized to either standard catheter removal in the office or catheter self-removal at home.
This is a prospective, randomized, two-parallel arm, non-inferiority trial to evaluate two methods of catheter discontinuation in women with post-operative urinary retention (POUR) after surgery for pelvic organ prolapse (POP) or stress urinary incontinence (SUI). This study will evaluate whether self-discontinuation of transurethral catheter by patients is non-inferior to standard office discontinuation based on rates of persistent POUR on post-operative day (POD) 1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Self-discontinuation of a transurethral catheter
University of Texas of Austin - Dell Seton Medical Center
Austin, Texas, United States
RECRUITINGSeton Medical Center Austin
Austin, Texas, United States
RECRUITINGAscension Seton Hays Hospital
Kyle, Texas, United States
RECRUITINGNumber of Participants With Postoperative Urinary Retention
Non-inferiority comparison of the rates of persistent POUR on POD1 between catheter self-discontinuation and standard office catheter. Persistent POUR is defined as PVR greater than 100 mL by bladder scan on POD1.
Time frame: Post-operative day 1
Rates of postoperative urinary tract infection (UTI)
Rates of postoperative UTI within 6 weeks of surgery - UTI will be defined as treatment with antibiotics for symptoms of UTI.
Time frame: within 6 weeks of surgery
Incidence of recurrent POUR
Recurrent POUR will be defined as any participant with successful POD1 voiding trial who later requires replacement of catheter due to recurrent POUR within 6 weeks of surgery. Recurrent POUR is defined as PVR greater than 100 mL by bladder scan after passing initial POD1 voiding trial.
Time frame: within 6 weeks of surgery
Number of postoperative patient encounters
Number of postoperative patient encounters, including any patient call to the office, electronic medical record message to office from patient, office visit, or emergency department visit.
Time frame: within 6 weeks of surgery
Patient satisfaction assessment via the Acceptability of Intervention Measure (AIM) Questionnaire
Patient satisfaction with catheter removal method as assessed via the Acceptability of Intervention Measure (AIM) Questionnaire. The AIM Questionnaire is a 4-item questionnaire on a 5-point Likert scale. Response Scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree Scoring Instructions: Scale is created by averaging responses. Scale values range from 1 to 5. The higher the score is, the higher the degree the patient finds the intervention acceptable.
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Seton Medical Center Williamson
Round Rock, Texas, United States
RECRUITINGTime frame: Post-operative day 1
Patient satisfaction assessment via the the Surgical Satisfaction Questionnaire - 8 (SSQ-8).
Patient satisfaction with catheter removal method as assessed via the Surgical Satisfaction Questionnaire - 8 (SSQ-8). The SSQ-8 is an 8-item questionnaire, with responses recorded on a 5-point Likert scale with responses from 0 "Very Unsatisfied" to 4 "Very Satisfied." Scoring uses the mean average of the 8 scores being multiplied by 25 (the questionnaire is considered incomplete if more than 2 items are not answered), yielding a potential range of scores from 0 to 100. The higher the score is, the greater the degree of surgical satisfaction.
Time frame: Post-operative day 1