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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

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 Not Applicable

Study Type : Interventional  (Clinical Trial)
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 : January 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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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 Name: Foley catheter




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01460303


Sponsors and Collaborators
University of Massachusetts, Worcester
Investigators
Principal Investigator: Michael Flynn, MD University of Massachusetts, Worcester

Responsible Party: Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT01460303     History of Changes
Other Study ID Numbers: H-13523
First Posted: October 26, 2011    Key Record Dates
Results First Posted: September 5, 2017
Last Update Posted: May 4, 2018
Last Verified: May 2018

Keywords provided by Michael Flynn, 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
Urination Disorders
Urologic Diseases