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

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.

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 Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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

Contacts and Locations

Sponsors and Collaborators

University of Massachusetts, Worcester

Investigators

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

More Information

• Responsible Party: Michael Flynn, Principal Investigator, University of Massachusetts, Worcester
• ClinicalTrials.gov Identifier: NCT01460303
• Other Study ID Numbers: H-13523
• First Posted: October 26, 2011
• 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