A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization

Wellspect HealthCare

Status: Completed

Conditions: Catheterization

Treatments: Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

Study type: Interventional

Funder types: Industry

Identifiers

NCT00799981

YA-LOF-0015

Details and patient eligibility

About

A study comparing a 10 cm catheter with a 7 cm catheter in a group of female patients who, on a routine bases, empty their bladder using urinary catheters, by measuring residual urine after intermittent catheterization.

Full description

The study personnel will conduct three bladder scans after each catheterization in order to obtain the mean residual urine volume. Each patient will catheterize herself two times with each product, i.e. a total of four catheterizations.

Diagnosis and BMI will be collected at visit 1 to assess whether the residual urine volume differs between these subgroups.

The hypothesis that the mean residual volumes were equal when using the 7 and the 10 centimeter catheters was tested by means of the Wilcoxon signed rank test.

Enrollment: 60 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Provision of signed informed consent
• Female subjects aged 18 years and over
• Experienced users of CIC with a minimum of one month of use
• Practice CIC a minimum of 1 time per day
• Practice CIC with female catheters with a maximum length of 20 cm
• Perform self-catheterization
• Sufficient hand function to be able to open and handle catheter packages
• Use catheters with Ch 10, 12 or 14

Exclusion criteria

• Pregnancy
• Ongoing symptomatic UTI
• Involvement in the planning and 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
• Participation in another clinical study during the study period
• Severe non-compliance to protocol as judged by the investigator and/or Astra Tech

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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60 participants in 6 patient groups

AABB

Experimental group

Description:

A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 7 cm then 10 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.

Treatment:

Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

ABAB

Experimental group

Description:

A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.

Treatment:

Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

ABBA

Experimental group

Description:

A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 7 cm then 10 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.

Treatment:

Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

BAAB

Experimental group

Description:

A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 7 cm then 7 cm then 10 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.

Treatment:

Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

BABA

Experimental group

Description:

A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then then 7 cm then 10 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.

Treatment:

Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm

BBAA

Experimental group

Description:

A=Coloplast SpeediCath Compact catheter, 7 cm B=Astra Tech POBE catheter, 10 cm 10 cm then 10 cm then 7 cm then 7 cm Four catheterizations in total, two catheterizations with each study product in a randomized order.

Treatment:

Device: A=SpeediCath Compact 7 cm and B=POBE 10 cm