Health TrialsbyHealthPanel

Comparison of Urinary Flow Study

ConditionUrinary Retention
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorWake Forest University Health Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • Coloplast Micro Zone Luja Female Catheter

    Device

    clean self-catheterization with 14 Fr Coloplast micro zone Luja female urinary catheter

  • Coloplast SpeediCath Female Catheter

    Device

    clean self-catheterization with 14 Fr two eyelet Coloplast SpeediCath female urinary catheter

Treatment groups

17 Participants
are divided into 2 treatment groups
Group A: Luja / SpeediCathActive comparator 2 interventions
Group B: SpeediCath / LujaActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Urinary 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
2

Total Urine Volume

total urine volume (mL) measured by uroflow device

Time frame
Day 1
3

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
4

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

Secondary outcomes

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

Time frame
Day 1
2

Measuring patient's satisfaction of using catheter-Part b

Patient's Satisfaction and Comments on Use of Luja Catheter

Time frame
Day 1

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Wake Forest University Health Sciences

Lead sponsor

Source ClinicalTrials.gov
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