Comparison of Urinary Flow Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Coloplast Micro Zone Luja Female Catheter, Coloplast SpeediCath Female Catheter.
- Who it may be relevant to
- Registry conditions: Urinary Retention. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Comparison of Urinary Flow Speed Using 14 Fr Two Eyelet Coloplast Female SpeediCath Urinary Catheter Versus 14 Fr Coloplast Micro Zone Luja Female Catheter in Female Patients Using Intermittent Catheters
Overview
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.
Detailed description
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.
Interventions
- Device Coloplast Micro Zone Luja Female Catheter
clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter - Device Coloplast SpeediCath Female Catheter
clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter
Primary outcome measures
- Urinary flow duration [Time frame: Day 1]
- Total Urine Volume [Time frame: Day 1]
- Peak Flow Rate [Time frame: Day 1]
- Time to Peak Flow [Time frame: Day 1]
- Mean Flow [Time frame: Day 1]
- Total Urine voiding time [Time frame: Day 1]
Secondary outcome measures (2)
- Measuring patient's satisfaction of using catheter-Part a [Time frame: Day 1]
- Measuring patient's satisfaction of using catheter-Part b [Time frame: Day 1]
Eligibility criteria
Inclusion criteria
- Female
- Regular use of intermittent catheters to empty bladder, for at least 1 month before enrolment
- Age 18 years or older
- Required to adhere to the intervention procedure and not participate in any other clinical studies throughout the duration of this study
Exclusion criteria
- Severe urinary tract abnormalities (e.g. excessive production of urinary mucus/sediments/debris)
- Hypersensitive to the ingredients in the catheters being tested
- Recent surgery, within 3 months
- Currently being treated for urinary tract infection
- Being pregnant or breastfeeding
- Non-English speaking
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Women's Center for Pelvic Health (Mercy) — Charlotte
Identifiers
NCT: NCT06918067 · IRB00128923