Consumer Evaluation of an Investigational Intermittent Catheter

NCT07714694 | Recruiting FDA Device

• 1 other identifier: 6049-CONT
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Incidence of Health Changes and Adverse Events During Usual-Catheter and Investigational-Catheter Use

  Number and nature of participant-reported health changes and adverse events collected during both the control-catheter period and the study-catheter period. Safety events will be categorized by incidence, severity, and relatedness.

  Through completion of both catheter-use periods, approximately 6 to 20 days

• Participant-Reported Overall Ease of Use of the Catheter

  Participant-reported overall ease of use of the catheter, assessed on a 5-point ordinal scale coded 1 to 5: 1 = Very Easy, 2 = Easy, 3 = Neither Easy nor Difficult, 4 = Difficult, and 5 = Very Difficult. Lower scores indicate easier overall use.

  Through completion of both catheter-use periods, approximately 6 to 20 days

Secondary Outcomes (42)

• Participant-Reported Ease of Inserting the Protective Tip Into the Urethral Opening

  Through completion of both catheter-use periods, approximately 6 to 20 days

• Participant-Reported Ease of Inserting the Catheter Into the Urethral Opening

  Through completion of both catheter-use periods, approximately 6 to 20 days

• Participant-Reported Ease of Advancing the Catheter Through the Protective Tip Into the Urethra

  Through completion of both catheter-use periods, approximately 6 to 20 days

• Participant-Reported Ease of Advancing the Catheter Through the Urethra to the Bladder

  Through completion of both catheter-use periods, approximately 6 to 20 days

• Participant-Reported Bladder Drainage and Bladder Emptying

  Through completion of both catheter-use periods, approximately 6 to 20 days

Study Arms (1)

Investigational Catheter

EXPERIMENTAL

Participants will first use 30 of their usual intermittent catheters and then switch to 30 study catheters in a fixed-sequence, within-participant design. All participants receive the same study catheter; responses from the usual-catheter period provide within-participant control context.

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

Interventions

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

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

Investigational Catheter

Eligibility Criteria

• Age: 22 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• is living in the USA
• is male
• is at least 22 years of age
• can speak, read, and write in English
• is self-catheterizing 3 or more times a day
• has been performing unassisted, self-catheterizations, with a Hydrophilic IC, for at least 1 month
• currently uses one of the hydrophilic ICs (length=40cm; size=Ch. 14) listed below:
• Hollister Incorporated VaPro Pocket Nelaton Tip (clear protective tip) (SKU 70144)
• Hollister Incorporated VaPro Pocket Coude (blue protective tip) (SKU 77144)
• Hollister Incorporated VaPro Coude (blue protective tip) (SKU 73144)
• Hollister Incorporated VaPro Plus Nelaton (clear protective tip) (SKU 74144)
• Hollister Incorporated VaPro Plus Pocket Nelaton (clear protective tip) (SKU 71144)
• Hollister Incorporated Onli Nelaton (SKU: 82144-30)
• Hollister Incorporated Onli Coudé (SKU: 85144)
• Wellspect LoFric Origo Nelaton (SKU: 443 14 40)

You may not qualify if:

• is currently receiving chemotherapy, has received chemotherapy within the past 30 days, or is scheduled to receive chemotherapy during the study (i.e., in the next 34 days)
• is currently undergoing, has previously underwent, or is planning to undergo radiation therapy to the bladder, prostate, or rectum during the study (i.e., in the next 34 days)
• is currently using one or more of the following oral or injectable steroid therapies for 30 days or more:
• Acthar Gel
• corticotropin
• Agamree
• vamorolone
• budesonide
• Cortef
• hydrocortisone
• Cortrophin Gel
• corticotrophin
• dexamethasone
• deflazacort
• prednisone

Sponsors & Collaborators

• Hollister Incorporated: lead

Study Sites (1)

Hollister Incorporated

Libertyville, Illinois, 60048, United States

RECRUITING

MeSH Terms

Conditions

Urinary Retention; Urinary Bladder, Neurogenic

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Neurologic Manifestations; Nervous System Diseases; Urinary Bladder Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jessica Simmons

  Hollister Incorporated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will first use 30 of their usual intermittent catheters and then will switch to 30 study catheters in a fixed-sequence, within-participant design. The study has one experimental arm because all participants receive the same study catheter; each participant serves as his own control through comparison of assessments made after the usual-catheter period and the study-catheter period.

Study Record Dates

• First Submitted: July 9, 2026
• First Posted: July 20, 2026
• Study Start: July 9, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: July 20, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)