Investigation of Non-CE Marked Intermittent Catheters.

NCT04543136 | Completed Results

• 1 other identifier: CP323
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter

Conditions

Retention, Urinary

Outcome Measures

Primary Outcomes (2)

• Residual Urine at 1st Flow-stop During Nurse Catheterization

  The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the nurse) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

  Immediately after the procedure/catheterization, up to 5 min.

• Residual Urine at 1st Flow-stop During Self-catheterization

  The residual urine at 1st flow-stop during nurse catheterization (i.e., catheterization performed by the participant) represents the volume of urine left in the bladder, the first time the urine stops running out of the catheter during bladder emptying/urination. This was assessed using a pressure sensor with time-logged weighing, meaning that a flow-stop was registered measuring the hydrostatic pressure at the outlet of an intermittent urinary catheter. Simultaneously, the collected urine was weighed and converted to volume, and the residual volume at first flow stop was calculated as the difference between the total urine volume collected and the volume collected at the first flow-stop.

  Immediately after the procedure/catheterization, up to 5 min.

Secondary Outcomes (10)

• Post-void Residual Urine After Nurse Catheterization

  Immediately after the procedure/catheterization, up to 15 min.

• Post-void Residual Urine After Self-catheterization

  Immediately after the procedure/catheterization, up to 15 min.

• Insertion Discomfort During Nurse Catheterization

  Immediately after the procedure/catheterization, up to 5 min.

• Urination Discomfort During Nurse Catheterization

  Immediately after the procedure/catheterization, up to 5 min.

• Withdrawal Discomfort During Nurse Catheterization

  Immediately after the procedure/catheterization, up to 5 min.

Study Arms (3)

Intermittent catheter; SpeediCath® Standard male

ACTIVE COMPARATOR

Participants underwent two catheterizations with standard of care intermittent catheter: The first was performed by a trained nurse, the second by the participant later the same day.

Device: SpeediCath® Standard male

New intermittent catheter Variant 1 for males

EXPERIMENTAL

Participants underwent two catheterizations with the new intermittent catheter Variant 1 for males: The first was performed by a trained nurse, the second by the participant later the same day.

Device: New intermittent Variant 1 catheter for males

New intermittent catheter Variant 2 for males

EXPERIMENTAL

Participants underwent two catheterizations with the new intermittent catheter Variant 2 for males: The first was performed by a trained nurse, the second by the participant later the same day.

Device: New intermittent Variant 2 catheter for males

Interventions

SpeediCath® Standard male DEVICE

Intermittent catheterization through the urethra draining the bladder, using SpeediCath® Standard male.

Intermittent catheter; SpeediCath® Standard male

New intermittent Variant 1 catheter for males DEVICE

Intermittent catheterization through the urethra draining the bladder, using the new Variant 1 catheter.

New intermittent catheter Variant 1 for males

New intermittent Variant 2 catheter for males DEVICE

Intermittent catheterization through the urethra draining the bladder, using the new Variant 2 catheter.

New intermittent catheter Variant 2 for males

Eligibility Criteria

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

You may qualify if:

• Male
• Minimum 18 years of age and with full legal capacity
• Daily intermittent catheterization for bladder management, with at least two catheters used on average pr. day, during the last 3 months
• Ability to self-catheterize
• Written informed consent, signed letter of authority and signed secrecy agreement given

You may not qualify if:

• Participation in any other clinical study during this investigation
• Symptoms of urinary tract infection as judged by the investigator
• Any know allergies towards ingredients in the products
• Relevant medical history that would prevent the subject from participation in the investigation (investigators judgement)

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet

Copenhagen, Denmark

Location

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Results Point of Contact

• Title: Vice President, Medical Affairs
• Organization: Coloplast A/S

clinical-studies@coloplast.com

+4549111111

Study Officials

• Per Bagi, MD

  Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2020
• First Posted: September 9, 2020
• Study Start: October 3, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: July 13, 2023
• Results First Posted: July 13, 2023

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)