Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

Study Overview
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Brief Summary
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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.

Official Title
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Clinical Trial of Patient Operated Valved Catheter Compared With Standard Indwelling Transurethral Catheter for Postoperative Bladder Management

Conditions
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Bladder Dysfunction, Urinary Retention

Intervention / Treatment
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* Device: Bladder catheter: OPTION-vf patient controlled catheter vs. indwelling transurethral catheter with leg bag
* Device: Transurethral catheter with leg bag


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPTION-vf patient controlled catheter<br>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<br>* 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).<br>* Other names: Patient Controlled Catheter;|
| Active Comparator: Transurethral catheter w/leg bag<br>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<br>* 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).<br>* Other names: Foley catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Catheter Related Pain | 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. | 5-10 days postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite Satisfaction Score (CSS) | The mean scores for the first 5 questions of the Post Operative Questionnaire were used to calculate a Composite Satisfaction Score. Total Pain (0 none, 10 worst) Total Catheter Related Pain Range Scale (0 none, 10 worst) Ease of catheter use (0 easy, 10 difficult) Feeling of frustration (0 none, 10 very much) 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. | 5-10 days postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Transurethral catheterization, Urinary retention, Bladder dysfunction, Patient comfort, Pelvic Reconstructive Surgery, Postoperative bladder dysfunction, Postoperative urinary retention