Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

• Sponsor: University of Massachusetts, Worcester (Other)
• Overall Status: Completed
• CT.gov ID: NCT01460303
• Collaborator: (none)
• Enrollment: 49
• Arms: 2
• Duration (Months): 59

Study Details

Study Description

Brief Summary

Following surgery for female urinary incontinence and/or pelvic organ prolapse, women are sometimes temporarily unable to empty their bladders and are sent home with a transurethral indwelling catheter attached to a bag which holds urine. The goal of this study is to compare a new type of patient-operated catheter without a bag to the catheter with a bag for ease of use, comfort and quality of life for patients during the postoperative recovery period. This new catheter, the OPTION-vf, is approved by the FDA and is available on the market.

Condition or Disease	Intervention/Treatment	Phase
Bladder Dysfunction; Urinary Retention	Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag; Device: Transurethral catheter with leg bag	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 49 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
• Study Start Date: Jan 1, 2011
• Actual Primary Completion Date: Dec 1, 2015
• Actual Study Completion Date: Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: OPTION-vf patient controlled catheter 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.	Device: 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).; Other Names: OPTION-vf™ Valved Female Urinary Catheter Patient Controlled Catheter
Active Comparator: Transurethral catheter w/leg bag 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.	Device: 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).; Other Names: Foley catheter

Outcome Measures

Primary Outcome Measures

1. Total Catheter Related Pain [5-10 days postoperatively]

   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.

Secondary Outcome Measures

1. Composite Satisfaction Score (CSS) [5-10 days postoperatively]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• patients undergoing surgery for urinary incontinence and/or pelvic organ prolapse at the UMass Memorial Medical Center with one of the Urogynecology/Reconstructive Pelvic Surgery faculty.

Exclusion Criteria:

• inability to provide consent

• <18 years old

• non-English speaking

• patients using intermittent self-catheterization

• patients sustaining bladder injury during surgery

• prisoners

• pregnant women

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• University of Massachusetts, Worcester

Investigators

• Principal Investigator: Michael Flynn, MD, University of Massachusetts, Worcester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT01460303
• Other Study ID Numbers: H-13523
• First Posted: Oct 26, 2011
• Last Update Posted: May 4, 2018
• Last Verified: May 1, 2018

• Keywords provided by Michael Flynn, Principal Investigator, University of Massachusetts, Worcester: Transurethral catheterization; Urinary retention; Bladder dysfunction; Patient comfort; Pelvic Reconstructive Surgery; Postoperative bladder dysfunction; Postoperative urinary retention
• Additional relevant MeSH terms: Urinary Retention

Study Results

Participant Flow

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 Participants	25	24	49
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	61.5 (12.4)	59.7 (12.4)	60.6 (1.27)
Sex: Female, Male (Count of Participants)
Female	25 100%	24 100%	49 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	22 88%	21 87.5%	43 87.8%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	3 12%	3 12.5%	6 12.2%
Region of Enrollment (participants) [Number]
United States	25 100%	24 100%	49 100%

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).
Measure Participants	24	25
Median (Standard Deviation) [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).
Measure Participants	24	25
Mean (Standard Deviation) [units on a scale]	2.23 (1.83)	3.62 (1.95)

Adverse Events

Time Frame	Up to six weeks after placement of catheter
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	0/24 (0%)		0/25 (0%)
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%)		0/25 (0%)
Other (Not Including Serious) Adverse Events
	OPTION-vf Patient Controlled Catheter		Transurethral Catheter w/Leg Bag
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	11/24 (45.8%)		6/25 (24%)
Renal and urinary disorders
Urinary Tract Infection	11/24 (45.8%)	11	6/25 (24%)	6

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

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

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.