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N/A N=30 Basic Science

Exploratory Study Investigating Urodynamic Parameters During Catheterisation

Spinal Cord Injuries · Enlarged Prostate With Lower Urinary Tract Symptoms

Bottom Line

View on ClinicalTrials.gov: NCT03337048 ↗
Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2024
Primary outcome: Primary: Discomfort During Catheter Insertion on a Visual Analogue Scale — 1.2; 1.0; 1.1 score on a scale

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
SpeediCath (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
Male
Sponsor
Coloplast A/S
Primary completion
May 2018

Outcome Measures

OutcomeResultp-value
PRIMARY
Discomfort During Catheter Insertion on a Visual Analogue Scale		 1.2; 1.0; 1.1 —

Summary

The objective of the study is to explore and understand how urodynamic parameters are affected when emptying the bladder with an intermittent catheter.

Eligibility Criteria

Inclusion Criteria

  • Have given written informed consent
  • Be at least 18 years of age and have full legal capacity
  • Be male
  • For healthy volunteers: Willing to comply with not using analgesics up to 24 hours prior to study visit
  • For healthy volunteers: Negative urine multistix (leukocytes and nitrite), or if positive, subsequent negative for bacterial growth in urine culture
  • For SCI and BPH patients: Use intermittent catheter daily and have used intermittent catheters for at least 2 months

Exclusion Criteria

  • Symptoms of urinary tract infections (frequent urination, stinging and pain at urination)
  • Participate in other clinical investigations related to urinary tract system during this investigation (Inclusion → termination)
  • For healthy volunteers: Abnormalities, diseases or surgical procedures performed in the lower urinary tract
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03337048). 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.

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