Bladder Dysfunction, Urinary Retention
Conditions
Keywords
Transurethral catheterization, Urinary retention, Bladder dysfunction, Patient comfort, Pelvic Reconstructive Surgery, Postoperative bladder dysfunction, Postoperative urinary retention
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.
Interventions
DEVICEBladder 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).
DEVICETransurethral 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).
Sponsors
University of Massachusetts, Worcester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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). | 25 |
| 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.
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). | 24 |
| Total | 49 |
Baseline characteristics
| Characteristic | OPTION-vf Patient Controlled Catheter | Total | Transurethral Catheter w/Leg Bag |
|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 12.4 | 60.6 years STANDARD_DEVIATION 1.27 | 59.7 years STANDARD_DEVIATION 12.4 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 6 Participants | 3 Participants |
| Race (NIH/OMB) White | 22 Participants | 43 Participants | 21 Participants |
| Region of Enrollment United States | 25 participants | 49 participants | 24 participants |
| Sex: Female, Male Female | 25 Participants | 49 Participants | 24 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 25 |
| other Total, other adverse events | 11 / 24 | 6 / 25 |
| serious Total, serious adverse events | 0 / 24 | 0 / 25 |
Outcome results
Primary
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
| Arm | Measure | Value (MEDIAN) | Dispersion |
|---|---|---|---|
| OPTION-vf Patient Controlled Catheter | Total Catheter Related Pain | 1.25 units on a scale | Standard Deviation 2.65 |
| Transurethral Catheter w/Leg Bag | Total Catheter Related Pain | 2.3 units on a scale | Standard Deviation 3.5 |
Secondary
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
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| OPTION-vf Patient Controlled Catheter | Composite Satisfaction Score (CSS) | 2.23 units on a scale | Standard Deviation 1.83 |
| Transurethral Catheter w/Leg Bag | Composite Satisfaction Score (CSS) | 3.62 units on a scale | Standard Deviation 1.95 |