The purpose of this research study is to compare the urinary flow speed of two different female catheters in patients that use intermittent catheters to empty their bladder. The "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" will be compared to the "14 Fr Coloplast Micro Zone Luja Female Catheter." Participants will have one study visit that should take about an hour and will also receive a follow-up telephone call about one week after the visit.
The purpose of this crossover study is to compare the urinary flow speed of two different female catheters manufactured by Coloplast, the "14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter" vs "14 Fr Coloplast Micro Zone Luja Female Catheter" in patients that use intermittent catheters to empty their bladder. Patients will be randomly assigned to group A or group B using a closed-envelope randomization method. Group A will self catheter with Luja, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with SpeediCath. Group B will self catheter with SpeediCath, backfill with sterile fluid volume equal to amount of urine collected, then self-catheter with Luja. Outcomes will be measured with office uroflow device.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
17
clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter
clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter
Women's Center for Pelvic Health (Mercy)
Charlotte, North Carolina, United States
RECRUITINGUrinary flow duration
Amount of time (seconds) it takes the urine to be released. The normal urinary flow duration for women is 15-18 ml/sec. A lower average flow rate could indicate a problem with the bladder or urinary tract.
Time frame: Day 1
Total Urine Volume
total urine volume (mL) measured by uroflow device
Time frame: Day 1
Peak Flow Rate
Peak flow (mL/sec) measured by uroflow device. Normal peak urine flow rates typically range from 15 to 25 mL/sec for women. Reduced flow rates or a slow stream can indicate urinary tract obstruction or other issues.
Time frame: Day 1
Time to Peak Flow
Time (seconds) to peak flow measured by uroflow device. A normal peak flow rate for women is typically between 15 and 25 mL/sec. A lower rate may indicate a blockage or obstruction in the urinary tract.
Time frame: Day 1
Mean Flow
Mean flow (mL/sec) measured by uroflow device. Normal mean urine flow rates typically range from 15 to 25 mL/sec for women. A slow or low flow rate may mean there is an obstruction at the bladder neck or in the urethra or a weak bladder.
Time frame: Day 1
Total Urine voiding time
Total time (seconds) to void urine from beginning of urine flow to the end of flow, measured by uroflow device.
Time frame: Day 1
Measuring patient's satisfaction of using catheter-Part a
Patient's preference of catheter type by using the Patient Global Impression of Improvement (PGI-I) scale
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Time frame: Day 1
Measuring patient's satisfaction of using catheter-Part b
Patient's Satisfaction and Comments on Use of Luja Catheter
Time frame: Day 1