Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

• 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: University of Massachusetts, Worcester
• Information provided by (Responsible Party): Michael Flynn, University of Massachusetts, Worcester

Tracking Information

• First Submitted Date: October 19, 2011
• First Posted Date: October 26, 2011
• Results First Submitted Date: May 1, 2017
• Results First Posted Date: September 5, 2017
• Last Update Posted Date: May 4, 2018
• Study Start Date: January 2011
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: 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
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Bladder Dysfunction
• Urinary Retention

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 2, 2017): 49
• Original Estimated Enrollment (submitted: October 24, 2011): 160
• Actual Study Completion Date: December 2015
• Actual Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT01460303
• Other Study ID Numbers: H-13523
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Michael Flynn, University of Massachusetts, Worcester
• Study Sponsor: University of Massachusetts, Worcester
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Massachusetts, Worcester
• Verification Date: May 2018