Clinical trial NCT00799981: A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
Official title: A Multi Centre, Single-blind, Randomized, Cross-over Study Comparing Two Female Catheters With Different Length in Terms of Residual Urine After Intermittent Catheterization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization
Lead sponsor: Wellspect HealthCare
Sponsor class: INDUSTRY
First posted: 2008-12-01
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: The study was designed as a randomised, single blind, cross-over study to eliminate bias.

Every subject was catheterisized with both 7 cm and 10 cm long catheters.
Primary purpose: OTHER

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Bladder Scan Measurements of Residual Urine Volume
timeFrame: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
Secondary outcomes:
measure: Number of Subjects With a Residual Volume >5mL or ≤5mL
timeFrame: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. At least 2 hours had to pass between 2 catheterizations.
measure: Number of Subjects With a Residual Volume >10mL or ≤10mL
timeFrame: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
measure: Number of Subjects With a Residual Volume >30mL or ≤30mL
timeFrame: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
measure: Number of Subjects With a Residual Volume >50mL or ≤50mL
timeFrame: Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated. A maximum of 5 minutes were allowed to elapse between catheterization and bladder scan.
measure: Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)
timeFrame: Question asked minutes after catheterization.
Other outcomes:
Locations:
city: Borås
country: Sweden
facility: Rehabiliteringskliniken, Södra Älvsborgs Sjukhus
city: Gothenburg
country: Sweden
facility: Verksamhet Urologi, Sahlgrenska Universitetssjukhuset
city: Lund
country: Sweden
facility: Clinical Research and Trial Centre, Lund University Hospital
Study officials:
affiliation: Clinical Research and Trial Centre, Lund University Hospital
name: Ulf Malmqvist, MD, PhD, Assoc.Prof.
role: PRINCIPAL_INVESTIGATOR
References: