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Consumer Evaluation of an Investigational Intermittent Catheter

NCT07714694 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-20

No results posted yet for this study

Summary

This clinical study is designed to evaluate the initial safety and performance of an investigational intermittent urinary catheter in people who use intermittent catheterization. Participants will use the study catheter and provide feedback on their experience, including ease of insertion, advancement through the urethra, bladder drainage, withdrawal, comfort, confidence, satisfaction, and overall ease of use.

Safety will be evaluated through reported health changes and adverse events. Device performance and user experience will be assessed using participant questionnaires and comparisons with the participant's current intermittent catheter, including questions related to catheter handling, comfort during catheterization, perceived ability to empty the bladder, likelihood of future use, and product preference.

The study is intended to generate descriptive information on the initial clinical use of the investigational catheter and to help characterize its safety, usability, comfort, satisfaction, and performance relative to participants' current intermittent catheter products.

Conditions

  • Urinary Retention
  • Neurogenic Bladder

Interventions

DEVICE

An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

An intermittent urethral urinary catheter with a tip, tube and drainage eyelets

Sponsors & Collaborators

  • Hollister Incorporated

    lead INDUSTRY

Principal Investigators

  • Jessica Simmons · Hollister Incorporated

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-09
Primary Completion
2026-10-31
Completion
2026-10-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07714694 on ClinicalTrials.gov