Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

Not Applicable

Completed

• Conditions: Urinary Retention; Bladder Dysfunction
• Interventions: Device: Transurethral catheter with leg bag

• Registration Number: NCT01460303
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-10-19
• Study First Submitted QC: 2011-10-24
• Study First Posted: 2011-10-26
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Results First Submitted: 2017-05-01
• Results First Submitted QC: 2017-08-02
• Results First Posted: 2017-09-05
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-02
• Last Update Posted: 2018-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 49

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Transurethral catheter w/leg bag	Transurethral catheter with 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.

Primary Outcome Measures

Name	Time	Method
Total Catheter Related Pain	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

Name	Time	Method
Composite Satisfaction Score (CSS)	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.