Trial Outcomes & Findings for RCT Foley Catheter Study for Elective TJA (NCT NCT05428020)

Results Overview

All patients were monitored per hospital protocol for urinary retention. After removal of catheter (control group) and those without (experimental group) upon arrival in the PACU (post anesthesia care unit), patients were given 4 hours to void a volume corresponding to 30ml/hour. If the patient failed to do so, they would have their bladder scanned. Bladder scanned results were all reported by 4 hours after surgery. Patients inability to void a volume corresponding to 30ml/hour AND after straight catheterization (per hospital protocol), meant they developed POUR following surgery.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

388 participants

Primary outcome timeframe

While inpatient following surgery

Results posted on

2023-08-03

Participant Flow

Participant milestones

Participant milestones
Measure	Indwelling Foley Catheter Short-term indwelling foley catheter Indwelling foley catheter: short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).	No Foley Catheter No foley catheter No foley catheter: No foley catheter is placed for surgery
Overall Study STARTED	194	194
Overall Study COMPLETED	194	194
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

RCT Foley Catheter Study for Elective TJA

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Indwelling Foley Catheter n=194 Participants Short-term indwelling foley catheter Indwelling foley catheter: short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).	No Foley Catheter n=194 Participants No foley catheter No foley catheter: No foley catheter is placed for surgery	Total n=388 Participants Total of all reporting groups
Sex: Female, Male Male	69 Participants n=5 Participants	74 Participants n=7 Participants	143 Participants n=5 Participants
Race/Ethnicity, Customized Race · White/caucasion	144 Participants n=5 Participants	158 Participants n=7 Participants	302 Participants n=5 Participants
Race/Ethnicity, Customized Race · Black/African American	46 Participants n=5 Participants	32 Participants n=7 Participants	78 Participants n=5 Participants
Race/Ethnicity, Customized Race · Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	194 participants n=5 Participants	194 participants n=7 Participants	388 participants n=5 Participants
Age, Continuous	67.36 years n=5 Participants	67.12 years n=7 Participants	67.24 years n=5 Participants
Sex: Female, Male Female	125 Participants n=5 Participants	120 Participants n=7 Participants	245 Participants n=5 Participants

PRIMARY outcome

Timeframe: While inpatient following surgery

All patients were monitored per hospital protocol for urinary retention. After removal of catheter (control group) and those without (experimental group) upon arrival in the PACU (post anesthesia care unit), patients were given 4 hours to void a volume corresponding to 30ml/hour. If the patient failed to do so, they would have their bladder scanned. Bladder scanned results were all reported by 4 hours after surgery. Patients inability to void a volume corresponding to 30ml/hour AND after straight catheterization (per hospital protocol), meant they developed POUR following surgery.

Outcome measures

Outcome measures
Measure	Indwelling Foley Catheter n=194 Participants Short-term indwelling foley catheter Indwelling foley catheter: short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).	No Foley Catheter n=194 Participants No foley catheter No foley catheter: No foley catheter is placed for surgery
Number of Patients Who Developed Postoperative Urinary Retention (POUR), Unable to Void a Volume Greater Than or Equal to 30ml/hr	4 Participants	5 Participants

SECONDARY outcome

Timeframe: up to 3 weeks after surgery

Patients who are treated following Total Joint Arthroplasty for UTI

Outcome measures

Outcome measures
Measure	Indwelling Foley Catheter n=194 Participants Short-term indwelling foley catheter Indwelling foley catheter: short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).	No Foley Catheter n=194 Participants No foley catheter No foley catheter: No foley catheter is placed for surgery
Urinary Tract Infections (UTI) as Complication up to 3 Weeks Following Total Joint Arthroplasty	3 Participants	1 Participants

SECONDARY outcome

Timeframe: While inpatient at hospital, immediately following surgery

Patient requires 1 or more straight catheterization while inpatient, due to inability to void 30ml/hr during the patient's hospital stay. Straight catheterizations are performed by placing an indwelling catheter when indicated by retention of ≥450 mL on bladder scans. Bladder scans are performed per hospital protocol for patients unable to void a volume of 30ml/hr in the first 4 hours following surgery. If bladder shows 150 ml to 349 ml of urine, patients are given another 4 hours to void, followed by a repeat bladder scan. If unable to void at that time, or bladder volume is \>450ml, patient will receive one-time catheterization. If bladder scan shows 350 ml to 449 ml of urine, they will be given 2 hours to void and repeat bladder scan. If unable to void or bladder volume is \>450 ml, patient receives one time catheterization. If patient receives straight catheterization, they're monitored according to protocol and a second straight catheterization is done if necessary.

Outcome measures

Outcome measures
Measure	Indwelling Foley Catheter n=194 Participants Short-term indwelling foley catheter Indwelling foley catheter: short-term indwelling catheter inserted in the operating room prior to surgery, removed upon arrival to the floor from post-anesthesia care unit (approx 2-3 hours after surgery).	No Foley Catheter n=194 Participants No foley catheter No foley catheter: No foley catheter is placed for surgery
Straight Catheterization Required While Inpatient Following Total Joint Arthroplasty	10 Participants	14 Participants

Adverse Events

Indwelling Foley Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No Foley Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Anne DeBenedetti, Director of Research, Adult Reconstruction

Rush University Medical Center

Phone: 3124322468

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place