Back to resultsPatient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Primary Purpose
Bladder Dysfunction, Urinary Retention
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag
Transurethral catheter with leg bag
Sponsored by
About this trial
This is an interventional treatment trial for Bladder Dysfunction focused on measuring Transurethral catheterization, Urinary retention, Bladder dysfunction, Patient comfort, Pelvic Reconstructive Surgery, Postoperative bladder dysfunction, Postoperative urinary retention
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
OPTION-vf patient controlled catheter
Transurethral catheter w/leg bag
Arm 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.
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.
Outcomes
Primary Outcome Measures
Total Catheter Related Pain
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
Composite Satisfaction Score (CSS)
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.
Full Information
NCT ID
NCT01460303
First Posted
October 19, 2011
Last Updated
May 2, 2018
Sponsor
University of Massachusetts, Worcester
1. Study Identification
Unique Protocol Identification Number
NCT01460303
Brief Title
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Official Title
Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Dysfunction, Urinary Retention
Keywords
Transurethral catheterization, Urinary retention, Bladder dysfunction, Patient comfort, Pelvic Reconstructive Surgery, Postoperative bladder dysfunction, Postoperative urinary retention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
49 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPTION-vf patient controlled catheter
Arm Type
Experimental
Arm 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.
Arm Title
Transurethral catheter w/leg bag
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag
Other Intervention Name(s)
OPTION-vf™ Valved Female Urinary Catheter, Patient Controlled Catheter
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Transurethral catheter with leg bag
Other Intervention Name(s)
Foley catheter
Intervention Description
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).
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Flynn, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
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