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

Wellspect HealthCare60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Catheterization

Interventions

A=SpeediCath Compact 7 cm and B=POBE 10 cmDEVICE

Catheterization should resemble the daily use as far as possible and at least 2 hours had to pass between 2 catheterizations.The study centre decided whether the subject performed all four catheterizations on one or several days.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Rehabiliteringskliniken, Södra Älvsborgs Sjukhus

Borås, Sweden

Verksamhet Urologi, Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Clinical Research and Trial Centre, Lund University Hospital

Lund, Sweden

Outcomes

Primary Outcomes

Bladder Scan Measurements of Residual Urine Volume

Measurements were performed with the bladder scan BVI 3000. The primary outcome variable was average residual urine volume (mL) calculated from repetitive bladder scans performed after each catheterization. Three bladder scan measurements were performed immediately after each catheterization and a mean value was calculated.

Time frame: 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

Number of Subjects With a Residual Volume >5mL or ≤5mL

Time frame: 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.

Number of Subjects With a Residual Volume >10mL or ≤10mL

Number of Subjects With a Residual Volume >30mL or ≤30mL

Number of Subjects With a Residual Volume >50mL or ≤50mL

Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.