Clinical trial NCT01295281: Evaluation of a New Catheter Material for Intermittent Catheterization
Official title: A Prospective, Randomized, Cross-over Study - Evaluation of a New Catheter Material for Intermittent Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization (Clean, Intermittent Urinary Catheterization)
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2011-02-14
Enrollment: 107
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e. clinically non-inferior when using POBE 2.0 compared to PVC.

Secondary objectives are to evaluate the safety and the subject's perception associated with the use of the catheters, assessed by the recording of adverse events and the ease of handling by means of a subjective assessment scale.


Eligibility criteria: Inclusion Criteria:

* Provision of informed consent
* Males, aged 18 years and over
* Maintained urethra sensibility
* Practice intermittent self-catheterization at least 2 times daily
* Using catheters in the length of 40 cm and size charrière (Ch) 12 or Ch 14
* Experienced practitioners of intermittent self-catheterization defined as a minimum of three months on therapy
* Experience of using LoFric catheter within the last 12 months prior to study entry
* Adults able to read, write and understand information given to them regarding the study

Exclusion Criteria:

* Ongoing, symptomatic urinary tract infection (UTI) at enrolment as judged by investigator
* Known urethral stricture at enrolment as judged by investigator
* Involvement in the planning and/or conduct of the study (applies to both Astra Tech staff or staff at the study site)
* Previous enrolment or randomisation of treatment in the present study

Primary outcomes:
measure: Number of Participants With Discomfort
timeFrame: At 7 and 14 days after randomization, respectively
Secondary outcomes:
measure: Perception of Pain
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Burning Sensation
timeFrame: At 7 and 14 days after randomization, respectively
measure: Presence of Bleeding
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of "Other Discomfort"
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Stiffness/ Rigidity
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Catheter Eyes
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Catheter Adherence
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Catheter Tip
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Slipperiness
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Smoothness
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Resistance
timeFrame: At 7 and 14 days after randomization, respectively
measure: Perception of Discomfort Due to Other Causes
timeFrame: At 7 and 14 days after randomization, respectively
Other outcomes:
Locations:
city: Alingsås
country: Sweden
facility: Kirurg och Urologmottagningen, Alingsås lasarett
city: Borås
country: Sweden
facility: Urologcentrum
city: Gävle
country: Sweden
facility: Kirurg- och urologmottagningen, Gävle Sjukhus
city: Göteborg
country: Sweden
facility: Urologmottagningen, Lundby Sjukhus
city: Skövde
country: Sweden
facility: Uroterapimottagningen Kärnsjukhuset Skövde
city: Uddevalla
country: Sweden
facility: Urologmottagningen Uddevalla sjukhus
Study officials:
affiliation: Kärnsjukhuset Skövde
name: Birgit Johansson, Urotherapist
role: PRINCIPAL_INVESTIGATOR
References: