NCT02965066

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

November 11, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 16, 2016

Completed
Last Updated

November 16, 2016

Status Verified

November 1, 2016

Enrollment Period

2 months

First QC Date

November 11, 2016

Last Update Submit

November 11, 2016

Conditions

Incontinence, Urinary

Outcome Measures

Primary Outcomes (1)

  • Pain

    The VAS scale is used to measure the pain experienced by the subjects at catheterisation

    1 day

Study Arms (2)

First Coloplast Test catheter; then Speedicath catheter

EXPERIMENTAL

The subjects allocated to this arm first test Coloplast Test catheter and after cross over test the comparator speedicath catheter

Device: Coloplast Test CatheterDevice: Coloplast Speedicath

First Speedicath catheter; then Coloplast Test catheter

EXPERIMENTAL

The subjects allocated to this arm first test Speedicath catheter and after cross over test the Coloplast test catheter

Device: Coloplast Test CatheterDevice: Coloplast Speedicath

Interventions

Coloplast Test CatheterDEVICE

Newly developed intermittent catheter

First Coloplast Test catheter; then Speedicath catheterFirst Speedicath catheter; then Coloplast Test catheter
Coloplast SpeedicathDEVICE

Marketed Coloplast Speedicath catheter

First Coloplast Test catheter; then Speedicath catheterFirst Speedicath catheter; then Coloplast Test catheter

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Have given written informed consent and signed letter of authority
  • Be at least 18 years of age and have full legal capacity
  • Be a male
  • Willing to refrain from using analgetics up to 24 hours prior to catheterization visits
  • Have a negative urine multistix - erythrocytes (Microscopic haematuria)
  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet

Coppenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Urinary Incontinence

Condition Hierarchy (Ancestors)

Urination DisordersUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesLower Urinary Tract SymptomsUrological ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Per Bagi, MD

    MD at the clinic of 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

September 1, 2016

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

November 16, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)