Trial Outcomes & Findings for Combined Spinal Epidural Urinary Retention (NCT NCT01597791)

Last Updated: 2018-10-05

Results Overview

This study will be assessed by collecting a twenty-four to forty-eight hour midstream urine sample and performing a urine culture. The clinical and laboratory criteria used to define a urinary tract infection.

Recruitment status

TERMINATED

Study phase

Target enrollment

56 participants

Primary outcome timeframe

48 Hours

Results posted on

2018-10-05

Participant Flow

Participant milestones

Participant milestones
Measure	Foley Catheter Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Foley catheter: Foley catheter placement after CSE.	No Foley Catheter Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
Overall Study STARTED	28	28
Overall Study COMPLETED	20	18
Overall Study NOT COMPLETED	8	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Foley Catheter Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Foley catheter: Foley catheter placement after CSE.	No Foley Catheter Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
Overall Study Physician Decision	2	1
Overall Study Cesarean Section	6	7
Overall Study Subject withdrawal	0	1
Overall Study Protocol Violation	0	1

Baseline Characteristics

Combined Spinal Epidural Urinary Retention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Foley Catheter n=20 Participants Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Foley catheter: Foley catheter placement after CSE.	No Foley Catheter n=18 Participants Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.	Total n=38 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	34 years STANDARD_DEVIATION 6.8 • n=5 Participants	33 years STANDARD_DEVIATION 3.8 • n=7 Participants	33.4 years STANDARD_DEVIATION 5.6 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 Participants n=5 Participants	18 Participants n=7 Participants	38 Participants n=5 Participants

PRIMARY outcome

Timeframe: 48 Hours

Outcome measures

Outcome measures
Measure	Foley Catheter n=20 Participants Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Foley catheter: Foley catheter placement after CSE.	No Foley Catheter n=18 Participants Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
Number of Participants With Positive Urine Culture	3 participants with positive urine culture	1 participants with positive urine culture

Adverse Events

Foley Catheter

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

No Foley Catheter

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Foley Catheter n=20 participants at risk Control group will have a Foley catheter placed after the CSE is performed as is the usual practice at this institution. Foley catheter: Foley catheter placement after CSE.	No Foley Catheter n=18 participants at risk Spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals. No foley catheter: Spontaneous Micturation/ Post Void Residual. the spontaneous micturition algorithm will be assessed for spontaneous micturition and post void residual (PVR) volumes via ultrasonography at regular time intervals.
Renal and urinary disorders Urinary Retention	30.0% 6/20 • Number of events 6 • 1 day Urinary retention	33.3% 6/18 • Number of events 6 • 1 day Urinary retention

Additional Information

Paul Fitzgerald

Northwestern University

Phone: 312-695-1064

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place