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Investigation of New Intermittent Catheters in Healthy Volunteers

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ClinicalTrials.gov Identifier: NCT04445051
Recruitment Status : Recruiting
First Posted : June 24, 2020
Last Update Posted : June 24, 2020
Sponsor:
Information provided by (Responsible Party):
Coloplast A/S

Brief Summary:
Investigation of non-CE marked intermittent catheters. The study is a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

Condition or disease Intervention/treatment Phase
Retention, Urinary Device: New intermittent catheters variation 1 and 2 for both male and females Not Applicable

Detailed Description:
The CP322 study is an investigation of non-CE marked intermittent catheters which will be conducted in Denmark. The study is a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Masking Description: Single-blinded study
Primary Purpose: Prevention
Official Title: Exploratory Investigation on Performance and Safety of New Intermittent Catheters in Healthy Volunteers
Actual Study Start Date : June 2, 2020
Estimated Primary Completion Date : November 30, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Standard of care
SpeediCath® standard Male and Female
Device: New intermittent catheters variation 1 and 2 for both male and females
The new catheters are not named at this point but are intended for intermittent drainage of the bladder.

Experimental: New intermittent catheter variation 1 for male and female
New intermittent catheter variation 1 for male and female
Device: New intermittent catheters variation 1 and 2 for both male and females
The new catheters are not named at this point but are intended for intermittent drainage of the bladder.

Experimental: New intermittent catheter variation 2 for male and female
New intermittent catheter variation 2 for male and female
Device: New intermittent catheters variation 1 and 2 for both male and females
The new catheters are not named at this point but are intended for intermittent drainage of the bladder.




Primary Outcome Measures :
  1. Residual urine at 1st clogging [ Time Frame: Immediately after procedure/catherterization ]
    Volume of residual urine at 1st clogging assessed by a pressure sensor with time-logged weighing


Secondary Outcome Measures :
  1. Residual urine post catheterisation [ Time Frame: Immediately after procedure/catherterization ]
    Volume of residual urine post catheterization assessed by ultrasound scan

  2. Discomfort [ Time Frame: Immediately after procedure/catherterization and Immediately after first normal voiding after procedure/catherterization. ]
    Discomfort measured using Visual Analogue Scale (VAS). A tool used to help a person rate the intensity of certain sensations and feelings, such as pain. The visual analog scale for pain/discomfort is a straight line of 10 cm with one end meaning no pain/discomfort and the other end meaning the worst pain/discomfort imaginable. The subject marks a point on the line that matches the amount of pain/discomfort he or she feels.

  3. Adverse events [ Time Frame: Up to 42 days ]
    Number of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Is at least 18 years of age and has full legal capacity
  2. Has given written informed consent and signed letter of authority and secrecy agreement
  3. Willing to comply with not using analgesics1 up to 24 hours prior to catheterisation visits
  4. Negative urine multistix - erythrocytes (haematuria)

Exclusion Criteria:

  1. Participation in any other clinical investigations during this investigation
  2. Known hypersensitivity towards any of the test products
  3. Symptoms of urinary tract infections (UTIs) (Investigators judgement)
  4. Pregnant or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04445051


Contacts
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Contact: Johanne L. Gotfredsen, PhD +4549113350 dkjoat@coloplast.com
Contact: Stine Haandbæk Sommersdahl +4549113299 dksths@coloplast.com

Locations
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Denmark
Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet Recruiting
Copenhagen, Copenhagen Ø, Denmark, 2100
Contact: Per Bagi, MD    +45 35 45 21 11    Per.Bagi@regionh.dk   
Contact: Rikke Permild    +45 35 45 21 11      
Sponsors and Collaborators
Coloplast A/S
Investigators
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Principal Investigator: Per Bagi, MD Blegdamsvej 9, Urologisk klinik Afsnit 2112, Rigshospitalet, Denmark
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Responsible Party: Coloplast A/S
ClinicalTrials.gov Identifier: NCT04445051    
Other Study ID Numbers: CP322
First Posted: June 24, 2020    Key Record Dates
Last Update Posted: June 24, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Urinary Retention
Urination Disorders
Urologic Diseases