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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

Tracking Information
First Submitted Date  ICMJE October 19, 2011
First Posted Date  ICMJE October 26, 2011
Results First Submitted Date  ICMJE May 1, 2017
Results First Posted Date  ICMJE September 5, 2017
Last Update Posted Date May 4, 2018
Study Start Date  ICMJE January 2011
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
Total Catheter Related Pain [ Time Frame: 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
Urinary Catheter Evaluation Questionnaire [ Time Frame: 5-10 days postoperatively ]
The urinary catheter evaluation questionnaire will be administered at the time patients return for their bladder challenge, normally between 5-10 days postop. The questionnaire focuses on comfort and ease of use of the catheter to which patients were randomized following failed bladder challenge. The questionnaire consists of seven questions with response choices ranging from "no discomfort" to "extreme discomfort", for example.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 2, 2017)
Composite Satisfaction Score (CSS) [ Time Frame: 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.
  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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 24, 2011)
Number of trials to successful passage of bladder challenge [ Time Frame: 5 days to ~30 days ]
Bladder challenge is considered "passed" when a patient is able to void adequately and spontaneously (without the assistance of a catheter).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter
Official Title  ICMJE Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Bladder Dysfunction
  • Urinary Retention
Intervention  ICMJE
  • 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
  • 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 Name: Foley catheter
Study Arms  ICMJE
  • 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.
    Intervention: Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag
  • 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.
    Intervention: Device: Transurethral catheter with leg bag
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 2, 2017)
49
Original Estimated Enrollment  ICMJE
 (submitted: October 24, 2011)
160
Actual Study Completion Date  ICMJE December 2015
Actual Primary Completion Date December 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01460303
Other Study ID Numbers  ICMJE H-13523
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Michael Flynn, University of Massachusetts, Worcester
Study Sponsor  ICMJE University of Massachusetts, Worcester
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael Flynn, MD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP