Clinical Study Investigating Safety and Performance of a New Urinary Intermittent Catheters in Healthy Volunteers

NCT02965105 | Completed

• 1 other identifier: CP271
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of the study is to test the performance and safety of a newly developed intermittent catheter

Conditions

Incontinence, Urinary

Outcome Measures

Primary Outcomes (1)

• Pain

  Pain experienced by the subjects at catheterisation is measure with the VAS scale

  1 day

Study Arms (2)

First Coloplast Test Catheter; then Speedicath

EXPERIMENTAL

The subjects allocated to this arm first test Coloplast Test Catheter and then after cross over test the comparator Speedicath Catheter

Device: Coloplast Test Catheter; Device: Speedicath

First Speedicath; then Coloplast Test Catheter

EXPERIMENTAL

The subjects allocated to this arm first test Speedicath Catheter and then after cross over test Coloplast Test Catheter

Device: Coloplast Test Catheter; Device: Speedicath

Interventions

Coloplast Test Catheter DEVICE

This is a newly developed intermittent catheter

First Coloplast Test Catheter; then Speedicath; First Speedicath; then Coloplast Test Catheter

Speedicath DEVICE

This is a marketed Catheter which is used as comparator

First Coloplast Test Catheter; then Speedicath; First Speedicath; then Coloplast Test Catheter

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Have given written informed consent and signed letter of authority 2. Be at least 18 years of age and have full legal capacity 3. Be a male 4. Willing to refrain from using analgetics up to 24 hours prior to catheterization visits 5. Have a negative urine multistix - erythrocytes (Microscopic haematuria) 6. Have a negative urine multistix:
• Leukocytes
• Nitrite Or if positive, subsequent negative for bacterial growth in urine culture

You may not qualify if:

• Abnormalities, diseases or surgical procedures performed in the lower urinary tract
• Symptoms of urinary tract infections (at least one of the following: frequent urination, stinging or pain at urination)
• Known hypersensitivity toward any of the test products -

Sponsors & Collaborators

• Coloplast A/S: lead

Study Sites (1)

Rigshopsitalet

Copenhagen, København Ø, 2100, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lower Urinary Tract Symptoms; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Per Bagi, MD

  MD at the clinic for urology at Rigshospitalet

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 11, 2016
• First Posted: November 16, 2016
• Study Start: November 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: March 1, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)