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Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

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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:
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
Recruitment Details  
Pre-assignment Details  
Arm/Group Title OPTION-vf Patient Controlled Catheter Transurethral Catheter w/Leg Bag
Hide 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
Arm/Group Title OPTION-vf Patient Controlled Catheter Transurethral Catheter w/Leg Bag Total
Hide 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
Hide 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
1.Primary Outcome
Title Total Catheter Related Pain
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTION-vf Patient Controlled Catheter Transurethral Catheter w/Leg Bag
Hide 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)
Hide Description

The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score.

  1. Total Pain (0 none, 10 worst)
  2. Total Catheter Related Pain Range Scale (0 none, 10 worst)
  3. Ease of catheter use (0 easy, 10 difficult)
  4. Feeling of frustration (0 none, 10 very much)
  5. 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title OPTION-vf Patient Controlled Catheter Transurethral Catheter w/Leg Bag
Hide 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)
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
Hide 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%)    
Hide 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%)    
Hide 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
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Michael K. Flynn
Organization: UMass Medical School
EMail: Michael.Flynn@umassmemorial.org
Layout table for additonal information
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