Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

• ClinicalTrials.gov Identifier: NCT01460303
• Recruitment Status: Completed
• First Posted: October 26, 2011
• Results First Posted: September 5, 2017
• Last Update Posted: May 4, 2018
• Sponsor: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Michael Flynn, University of Massachusetts, Worcester

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Conditions: Bladder Dysfunction; Urinary Retention
• Interventions: Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag; Device: Transurethral catheter with leg bag
• Enrollment: 49

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	OPTION-vf Patient Controlled Catheter	Transurethral Catheter w/Leg Bag
Arm/Group Description	Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).	Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
Period Title: Overall Study
Started	25	24
Completed	25	24
Not Completed	0	0

Baseline Characteristics

Arm/Group Title		OPTION-vf Patient Controlled Catheter	Transurethral Catheter w/Leg Bag	Total
Arm/Group Description		Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).	Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).	Total of all reporting groups
Overall Number of Baseline Participants		25	24	49
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	25 participants	24 participants	49 participants
		61.5 (12.4)	59.7 (12.4)	60.6 (1.27)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	24 participants	49 participants
	Female	25 100.0%	24 100.0%	49 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	25 participants	24 participants	49 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	0 0.0%	0 0.0%	0 0.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	22 88.0%	21 87.5%	43 87.8%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	3 12.0%	3 12.5%	6 12.2%
Region of Enrollment; Measure Type: Number; Unit of measure: Participants
United States	Number Analyzed	25 participants	24 participants	49 participants
		25	24	49

Outcome Measures

1. Primary Outcome

Title	Total Catheter Related Pain
Description	Total Catheter Related Pain Range Scale (0 = none, to 10 = worst) on the Post Operative Questionnaire All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative questionnaire was completed by the subject one time at that appointment.
Time Frame	5-10 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPTION-vf Patient Controlled Catheter	Transurethral Catheter w/Leg Bag
Arm/Group Description:	Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm. Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).	Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm. Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
Overall Number of Participants Analyzed	24	25
Median (Standard Deviation); Unit of Measure: units on a scale
	1.25 (2.65)	2.3 (3.5)

2. Secondary Outcome

Title	Composite Satisfaction Score (CSS)
Description	The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.; Total Pain (0 none, 10 worst); Total Catheter Related Pain Range Scale (0 none, 10 worst); Ease of catheter use (0 easy, 10 difficult); Feeling of frustration (0 none, 10 very much); Limited social activities (0 none, 10 very much) All subjects were given and appointment for an outpatient voiding trial after hospital discharge. The Post Operative Questionnaire was completed by the subject one time at that appointment.
Time Frame	5-10 days postoperatively

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	OPTION-vf Patient Controlled Catheter	Transurethral Catheter w/Leg Bag
Arm/Group Description:	Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm. Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).	Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm. Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
Overall Number of Participants Analyzed	24	25
Mean (Standard Deviation); Unit of Measure: units on a scale
	2.23 (1.83)	3.62 (1.95)

Adverse Events

Time Frame	Up to six weeks after placement of catheter
Adverse Event Reporting Description	[Not Specified]
Arm/Group Title	OPTION-vf Patient Controlled Catheter		Transurethral Catheter w/Leg Bag
Arm/Group Description	Patients who fail postop bladder challenge and are randomized to "OPTION-vf" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag: OPTION-vf patient controlled catheter (transurethral catheter with external drainage valve to provide on-demand drainage of urine stored directly from the bladder), worn maximum of 30 days post-op until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).		Patients who fail postop bladder challenge and are randomized to "indwelling catheter with leg bag" arm will be instructed in the use and care of this catheter, discharged home with it in place and given an appointment between 5-10 days postop for a bladder challenge. Transurethral catheter with leg bag: Transurethral catheter w/leg bag urine storage, worn maximum of 30 days post-up until bladder challenge is passed. Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
All-Cause Mortality
	OPTION-vf Patient Controlled Catheter		Transurethral Catheter w/Leg Bag
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/24 (0.00%)		0/25 (0.00%)
Serious Adverse Events
	OPTION-vf Patient Controlled Catheter		Transurethral Catheter w/Leg Bag
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0.00%)		0/25 (0.00%)
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	OPTION-vf Patient Controlled Catheter		Transurethral Catheter w/Leg Bag
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/24 (45.83%)		6/25 (24.00%)
Renal and urinary disorders
Urinary Tract Infection *	11/24 (45.83%)	11	6/25 (24.00%)	6
* Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact

• Name/Title: Dr. Michael K. Flynn
• Organization: UMass Medical School
• EMail: Michael.Flynn@umassmemorial.org

• Responsible Party: Michael Flynn, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT01460303
• Other Study ID Numbers: H-13523
• First Submitted: October 19, 2011
• First Posted: October 26, 2011
• Results First Submitted: May 1, 2017
• Results First Posted: September 5, 2017
• Last Update Posted: May 4, 2018