Patient-operated Valved Catheter Versus Indwelling Transurethral Catheter

University of Massachusetts, Worcester49 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bladder Dysfunction Urinary Retention

Interventions

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).

Transurethral catheter with leg bagDEVICE

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).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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.

Time frame: 5-10 days postoperatively

Secondary Outcomes

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. 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.

Time frame: 5-10 days postoperatively