Recruiting

Coloplast Catheters

Sponsor:

Wake Forest University Health Sciences

Code:

NCT06918067

Conditions

Urinary Retention

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coloplast Micro Zone Luja Female Catheter

Coloplast SpeediCath Female Catheter

Study Details

Brief summary:

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.

Conditions

Urinary Retention

Study ID

NCT06918067

Start date

Nov 6, 2025

Status verified date

Mar, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

17 participants

Anticipated

Allocation

Randomized

Intervention Model

Crossover

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

active comparator: Luja / SpeediCath

Subjects randomized to this arm will perform intermittent self-catheterization using the Coloplast Micro Zone Luja Female Catheter first then have bladder backfilled with sterile fluid to the amount equal to the volume of first catheterization. Then the subject will perform intermittent self-catheterization using the Coloplast Female SpeediCath Urinary Catheter.

active comparator: SpeediCath / Luja

Subject randomized to this arm will perform intermittent self-catheterization using the Coloplast Female SpeediCath Urinary Catheter first then have bladder backfilled with sterile fluid to the amount equal to the volume of first catheterization. Then the subject will perform intermittent self-catheterization using the Coloplast Micro Zone Luja Female Catheter.

Interventions

Coloplast Micro Zone Luja Female Catheter

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

Coloplast SpeediCath Female Catheter

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

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Michael Kennelly, MD

704-304-1160michael.kennelly@atriumhealth.org

Zahra Bahrani-Mostafvai, PhD

704-304-1160Zahra.Bahranimostafavi@atriumhealth.org

Locations

Women's Center for Pelvic Health (Mercy)

Recruiting

Charlotte, North Carolina, United States, 28207

Contacts

Michael Kennelly, MD

Michael.Kennelly@atriumhealth.org

More Information

Sponsor

Wake Forest University Health Sciences

Last update posted

Mar 5, 2026

Last verified

Mar, 2026

Keywords

  • catheter
  • intermittent catheterization
  • bladder

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Wake Forest University Health Sciences on 2026-03-05.