Clinical trials: Intermittent Catheterization
Bacteriuria, Intermittent Catheterization
Open Prospective Study on Reduction of Bacteriuria Following Bladder Irrigation With Chlorhexidine
This a prospective, non-controlled, open, multi-center study evaluating the reduction of bacteriuria after bladder irrigation with chlorhexidine in spinal cord injured patients with chronic bacteriuria practicing intermittent…
- Trial name
- NCT01782404
- Testing
- Chlorhexidine
- Where
- 4 sites in Sweden
- Volunteers
- 50 people
- Sponsor
- Wellspect HealthCare
Healthy
Evaluation of Residual Urine After Intermittent Catheterisation
Intermittent catheterization is a well-known method used for emptying the bladder. The objective of this study is to compare the residual urine after intermittent catheterisation with 2 different, hydrophilic coated, intermittent…
- Trial name
- NCT00324233
- Testing
- Intermittent catheter, Compact intermittent catheter
- Where
- Denmark
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Neurogenic Detrusor Overactivity
Open-label, Long-term Safety, Efficacy, and Pharmacokinetics Study of Vibegron in Pediatric Subjects 2 Years to < 18 Years of Age With NDO and on CIC
The purpose of this study is to evaluate the safety, efficacy, and PK of Vibegron in pediatric participants with NDO who are regularly using CIC
- Trial name
- KANGUROO (NCT05491525)
- Testing
- Vibegron
- Where
- 38 sites in United States, Belgium and 14 more
- Volunteers
- 71 people
- Sponsor
- Urovant Sciences GmbH
Spinal Cord Injuries, Multiple Sclerosis
GentleCath Air (Urinary Self-catheterization) - Pain in Female Patients With Neurological Vesico-sphincter Disorders
The purpose of this study is to evaluate the rate of occurrence of urethral pain in female patients with neurological vesico-sphincter disorders whilst performing self-catheterization using GentleCath™ Air catheters.
- Conditions
- Spinal Cord Injuries, Multiple Sclerosis, Parkinsonian Disorders, Allodynia
- Trial name
- FollowAir (NCT04847609)
- Testing
- GentleCath™ Air catheter
- Sponsor
- ConvaTec Inc.
Urinary Incontinence
Intermittent Catheterisation on the Bladder Mucosa of Healthy Volunteers With a Prototype Micro Hole Zone Catheter
This investigation is a randomized, single-blinded, parallel, single-center investigation. In total, up to 50 subjects (40 completers) were included and each subject had two test visits overseen by the Principal Investigator…
- Trial name
- CP341 (NCT05224544)
- Testing
- Investigational prototype device, Comparator device
- Where
- United States
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Catheterization
A Comparison of Two Urinary Catheters of Different Lengths for Female Use, in Intermittent Catheterization
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.
- Trial name
- NCT00799981
- Testing
- A=SpeediCath Compact 7 cm and B=POBE 10 cm
- Where
- 3 sites in Sweden
- Volunteers
- 60 people
- Sponsor
- Wellspect HealthCare
Urinary Incontinence
Consumer Evaluation of Intermittent Catheter Product Modifications
This study aims to collect feedback from hydrophilic intermittent catheter end-users to assess user acceptance of the test hydrophilic intermittent catheter and generate evidence to support commercial marketing objectives.
- Trial name
- NCT04619992
- Testing
- Currently marketed Hydrophillic Intermittent Catheter, Test Hydrophilic Intermittent Catheter
- Where
- United States
- Volunteers
- 62 people
- Sponsor
- Hollister Incorporated
Spinal Cord Injuries
Intermittent Catheterization in Spinal Cord Injured Men
The aim of this investigation is to study how the position of different catheters affect drainage of the bladder.
- Trial name
- NCT02230540
- Testing
- SelfCath (comparator), Product A SelfCath and urine bag, Conveen Security+, Product B SelfCath and urine bag, Conveen Contour
- Where
- Denmark
- Volunteers
- 8 people
- Sponsor
- Coloplast A/S
Catheterization (Clean, Intermittent Urinary Catheterization)
Evaluation of a New Catheter Material for Intermittent Catheterization
The hypothesis to be investigated is if the tolerability of intermittent catheterization with Polyolefin Based Elastomer (POBE) 2.0 and Polyvinyl Chloride (PVC) is clinically equal - i.e.
- Trial name
- NCT01295281
- Testing
- LoFric POBE 2.0, LoFric PVC
- Where
- 6 sites in Sweden
- Volunteers
- 107 people
- Sponsor
- Wellspect HealthCare
Bladder Dysfunction, Multiple Sclerosis
Efficacy of Clean Intermittent Catheterization (CIC) in Multiple Sclerosis (MS) Patients With Bladder Dysfunction
The aims of this prospective, randomized study are: To assess the effect of clean intermittent catheterization (CIC) To investigate if MS patients will have symptom reduction (urgency, frequency, nocturia and incontinence) when…
- Trial name
- NCT00913510
- Testing
- CIC using LoFric Primo, Anticholinergic medication
- Where
- 5 sites in Belgium, Germany and 2 more
- Volunteers
- 24 people
- Sponsor
- Wellspect HealthCare
Retention, Urinary
Exploratory Study Investigating the Urinary Bladder During Intermittent Catheterization in Healthy and Spinal Cord Injured Male and Female Subjects Using an Upright MRI Scanner
This is an exploratory study investigating morphological and physiological changes of the lower urinary tract and surrounding structures during IC use in individuals with SCI, and during normal voiding and IC use in healthy…
- Trial name
- NCT07384559
- Testing
- MRI scan
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S
Neurogenic Bladder, Non-Neurogenic Bladder
Continence Care Registry
This observational research study aims to build a multinational electronic patient-reported outcomes (ePRO) registry of adult end users in outpatient and community settings using intermittent catheter(s) to void via the urethra…
- Trial name
- ConCaRe™ (NCT04924569)
- Where
- United States
- Volunteers
- 600 people
- Sponsor
- Hollister Incorporated
Urinary Catheterization
A Randomized, Fully-blinded Parallel Groups Study of Catheter Materials Used for Clean Intermittent Catheterisation
The study is designed as a randomized, double-blind, parallel-group, multi centre study comparing perception and tolerability of investigational product and comparator.
- Trial name
- NCT00753298
- Testing
- LoFric Primo (POBE) single-use urinary catheter, LoFric Primo (PVC) single-use urinary catheter
- Where
- 13 sites in Austria, Germany and 4 more
- Volunteers
- 195 people
- Sponsor
- Wellspect HealthCare
Intermittent Catheterization
Non-Interventional Study Among Users Of LoFric Origo
Primary objective: To evaluate compliance of LoFric Origo in a general intermittent catheterization (IC) population with the use of LoFric Origo, by means of a subjective assessment scale Secondary objectives: To evaluate the…
- Trial name
- NCT01796587
- Testing
- LoFric Origo
- Where
- 19 sites in Belgium, France and 4 more
- Volunteers
- 423 people
- Sponsor
- Wellspect HealthCare
Bacteriuria
Reduction of Bacteriuria in Subjects Practicing Intermittent Catheterization
The main objective is to investigate two types of antibacterial catheters regarding their antibacterial efficacy. The study will investigate if silver added to the coating of a urinary catheter exerts antibacterial activity that…
- Trial name
- NCT01143116
- Testing
- Silver-nitrate coated catheter ("Catheter A"), Degradable silver particle-coated catheter ("Catheter B")
- Where
- United Kingdom
- Volunteers
- 20 people
- Sponsor
- Wellspect HealthCare
Urinary Retention, Chronic
Evaluation of the Safety and Clinical Performance of the Connected Catheter Study
The objective of this study is to evaluate the safety and effectiveness of the Connected Catheter in males with chronic Urinary Retention, both in a clinical setting and an extended period of home use.
- Trial name
- NCT05330598
- Testing
- Connected Catheter
- Where
- 5 sites in United States
- Volunteers
- 26 people
- Sponsor
- Spinal Singularity
Urinary Retention
Alfuzosin Versus Placebo in Acute Urinary Retention
The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with…
- Trial name
- ALF-RIK (NCT00453908)
- Testing
- Alfuzosin
- Where
- Denmark
- Volunteers
- 160 people
- Sponsor
- Sanofi
Hematuria
Comparison of Microtrauma in Urethra After Usage of Different Catheters
The study is undertaken to investigate if the urethral microtrauma, caused by intermittent catheterization, differs between three hydrophilic catheters for intermittent catheterization, LoFric; SpeediCath (SC) and SpeediCath…
- Trial name
- NCT01600443
- Testing
- LoFric, SpeediCath, SpeediCath Compact Male
- Where
- Sweden
- Volunteers
- 21 people, healthy volunteers welcome
- Sponsor
- Wellspect HealthCare
Neurogenic Detrusor Overactivity, Spinal Cord Injuries
Dose Escalation Study of EG110A, Administered by Intradetrusor Injections to Adults With Neurogenic Detrusor Overactivity-related Incontinence Following Spinal Cord Injury Who Regularly Perform Clean Intermittent Catheterization
This is a first-in-human, Phase 1b/2a, open-label, dose-escalation study of a single treatment course consisting of multiple intradetrusor injections of EG110A in male and female adult participants with Neurogenic Detrusor…
- Trial name
- NCT06596291
- Testing
- EG110A
- Where
- 5 sites in United States
- Volunteers
- 16 people
- Sponsor
- Cyllene Therapeutics
Intermittent Urethral Catheterization
Reuse of Intermittent Urethral Catheters
The purpose of this study is to investigate and document real life safety and satisfaction of re-use of urethral catheters for intermittent self catheterization.
- Trial name
- NCT02129738
- Testing
- LoFric catheters
- Where
- 7 sites in United States, Australia
- Volunteers
- 39 people
- Sponsor
- Wellspect HealthCare