Trial Outcomes & Findings for Effect of Catheter on Postoperative Urinary Retention (NCT NCT04645264)

NCT ID: NCT04645264

Last Updated: 2022-09-16

Results Overview

How long was the patients post-operative stay?

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 7 participants
• Primary outcome timeframe: Date of surgery until the date of hospital discharge, up to 1 month
• Results posted on: 2022-09-16

Participant Flow

Participant milestones

Measure	Indwelling Foley Indwelling Foley placed during surgery Foley Catheter: The patient is catheterized during surgery.	Straight Catheter straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery Foley Catheter: The patient is catheterized during surgery.	No Catheter Patient is not catheterized
Overall Study STARTED	3	2	2
Overall Study COMPLETED	3	2	2
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Indwelling Foley n=3 Participants Indwelling Foley placed during surgery Foley Catheter: The patient is catheterized during surgery.	Straight Catheter n=2 Participants straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery Foley Catheter: The patient is catheterized during surgery.	No Catheter n=2 Participants Patient is not catheterized	Total n=7 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=3 Participants	0 Participants n=2 Participants	0 Participants n=2 Participants	0 Participants n=7 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=3 Participants	2 Participants n=2 Participants	1 Participants n=2 Participants	5 Participants n=7 Participants
Age, Categorical >=65 years	1 Participants n=3 Participants	0 Participants n=2 Participants	1 Participants n=2 Participants	2 Participants n=7 Participants
Age, Continuous	55 years n=3 Participants	57 years n=2 Participants	58 years n=2 Participants	57 years n=7 Participants
Sex: Female, Male Female	2 Participants n=3 Participants	1 Participants n=2 Participants	1 Participants n=2 Participants	4 Participants n=7 Participants
Sex: Female, Male Male	1 Participants n=3 Participants	1 Participants n=2 Participants	1 Participants n=2 Participants	3 Participants n=7 Participants
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	3 participants n=3 Participants	2 participants n=2 Participants	2 participants n=2 Participants	7 participants n=7 Participants

PRIMARY outcome

Timeframe: Date of surgery until the date of hospital discharge, up to 1 month

How long was the patients post-operative stay?

Outcome measures

Measure	Indwelling Foley n=3 Participants Indwelling Foley placed during surgery Foley Catheter: The patient is catheterized during surgery.	Straight Catheter n=2 Participants straight catheterization (in-and-out straight catheterization) will take place at the end of the surgery Foley Catheter: The patient is catheterized during surgery.	No Catheter n=2 Participants Patient is not catheterized
Length of Hospital Stay	3 days Interval 1.0 to 3.0	2 days Interval 1.0 to 3.0	2 days Interval 1.0 to 3.0

Adverse Events

Indwelling Foley

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Straight Catheter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

No 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

Kern Singh, MD

Rush University Medical Center

Phone: (312) 432-2435

Email: kern.singh@rushortho.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place