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

NCT00799981 | Completed Results

• 1 other identifier: YA-LOF-0015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Catheterization

Outcome Measures

Primary Outcomes (1)

• 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.

  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 (5)

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

  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

  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.

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

  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.

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

  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.

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

  Question asked minutes after catheterization.

Study Arms (6)

AABB

EXPERIMENTAL

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.

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

ABAB

EXPERIMENTAL

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.

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

ABBA

EXPERIMENTAL

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.

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

BAAB

EXPERIMENTAL

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.

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

BABA

EXPERIMENTAL

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.

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

BBAA

EXPERIMENTAL

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.

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

Interventions

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

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.

Also known as: Coloplast SpeediCath Compact 7 cm, Astra Tech POBE 10 cm

AABB; ABAB; ABBA; BAAB; BABA; BBAA

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wellspect HealthCare: lead

Study Sites (3)

Rehabiliteringskliniken, Södra Älvsborgs Sjukhus

Borås, SE-501 82, Sweden

Location

Verksamhet Urologi, Sahlgrenska Universitetssjukhuset

Gothenburg, SE-413 45, Sweden

Location

Clinical Research and Trial Centre, Lund University Hospital

Lund, SE-221 85, Sweden

Location

Results Point of Contact

• Title: Head of Medical Affairs
• Organization: Wellspect Health Care

mace@wellspect.com

+46313763000

Study Officials

• Ulf Malmqvist, MD, PhD, Assoc.Prof.

  Clinical Research and Trial Centre, Lund University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The subjects were handed out numbered boxes with the catheter randomised to be used and then cathererisized by herself. The investigator was blinded to which catheter was used.
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 28, 2008
• First Posted: December 1, 2008
• Study Start: November 1, 2008
• Primary Completion: January 1, 2009
• Study Completion: March 1, 2009
• Last Updated: May 18, 2021
• Results First Posted: May 18, 2021

Record last verified: 2021-04

Locations

SE (3)