Evaluation of Residual Urine After Intermittent Catheterisation

NCT ID: NCT00324233

Last Updated: 2013-01-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2006-06-30

Brief Summary

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Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent catheters. The study is a randomized, single blinded, crossover study including 24 healthy males.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SC

Speedicath (SC) catheter is a catheter for intermittent catherisation

Group Type ACTIVE_COMPARATOR

Intermittent catheter

Intervention Type DEVICE

SpeediCath catherter (SC) for intermittent catherisation

SCCM

SpeediCath Compact Male (SCCM) is a compact catheter for intermittent catherisation to be used by males

Group Type EXPERIMENTAL

Compact intermittent catheter

Intervention Type DEVICE

SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

Interventions

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Intermittent catheter

SpeediCath catherter (SC) for intermittent catherisation

Intervention Type DEVICE

Compact intermittent catheter

SpeediCath Compact Male catheter (SCCM) is a compact intermittent catheter for males

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Male
* 18 years and above
* A negative urine dip-stick
* Have signed informed written consent to participate

Exclusion Criteria

* The test participant has previous or current congenital deformity, diseases or operation in the lower urinary tract
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Coloplast A/S

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Per Bagi, MD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

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Rigshospitalet

Copenhagen, København Ø, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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DK052CC

Identifier Type: -

Identifier Source: org_study_id

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