N/A N=60 Randomized Double-blind Other

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

Catheterization

Bottom Line

View on ClinicalTrials.gov: NCT00799981 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2021

Primary outcome: Primary: Bladder Scan Measurements of Residual Urine Volume — 32.74; 34.78 Residual volume in mL — p=0.8762

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: A=SpeediCath Compact 7 cm and B=POBE 10 cm (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Wellspect HealthCare
Primary completion: Jan 2009

Outcome Measures

Outcome	Result	p-value
PRIMARY Bladder Scan Measurements of Residual Urine Volume	32.74; 34.78	0.8762
SECONDARY Number of Subjects With a Residual Volume >5mL or ≤5mL	42; 40; 18; 20	0.7905
SECONDARY Number of Subjects With a Residual Volume >10mL or ≤10mL	38; 37; 22; 23	1.00
SECONDARY Number of Subjects With a Residual Volume >30mL or ≤30mL	19; 26; 41; 34	—
SECONDARY Number of Subjects With a Residual Volume >50mL or ≤50mL	15; 16; 45; 44	—
SECONDARY Does the Subject's Bladder Feel Completely Empty After Catheterisation (All Subjects)	0.75; 0.83; -0.08	0.0273 sig

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00799981). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.