Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to compare compact intermittent catheters with standard coated intermittent catheters with regard to quality of life, using the Intermittent Self-Catheterisation Quality of life Measure.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Compact catheter | Experimental | Compact intermittent catheter |
|
| Standard Care | Active Comparator | Standard Care: Coated intermittent catheter normally used by subject |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SpeediCath Compact | Device | The SpeediCath Compact intermittent catheter is used for single-use urinary bladder drainage through the urethra. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life (0-100 Point) | Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life. | 6 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Chartier-Kastler, Proff | Hôpital Raymond poincarè, Service d'Urologie, Garches, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PrivatHospitalet Danmark, privat hospital, | Charlottenlund | Denmark | ||||
| Rigshospitalet, Urology clinic, |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34699062 | Derived | Prieto JA, Murphy CL, Stewart F, Fader M. Intermittent catheter techniques, strategies and designs for managing long-term bladder conditions. Cochrane Database Syst Rev. 2021 Oct 26;10(10):CD006008. doi: 10.1002/14651858.CD006008.pub5. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | First Compact Catheter, Then Standard Care | First period: Compact intermittent catheter from Coloplast. Second period: Standard Care: Coated intermittent catheter normally used by subject |
| FG001 | First Standard Care; Then Compact Catheter | First period: Standard Care: Coated intermittent catheter normally used by subject Second period: Compact catheter: Compact intermittent catheter from Coloplast |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 |
|
| |||||||||||||||||||||
| Period 2 |
|
The ITT population consistsed of 118 subjects.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | 125 subjects were randomized in this study, however 7 subjects discontinued only providing baseline data and were therefore excluded from the ITT population as they did not contribute with any endpoint data. The baseline and analysis data are based on the ITT population. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Quality of Life (0-100 Point) | Difference in intermittent self-catheterisation quality of life measure, comparing compact versus standard urinary intermittent catheters The range of the scale is 0-100 where a high score indicating a high level of Quality of Life. | The primary analysis was based on the ITT population which included 118 subjects. 7 subjects were excluded from the ITT population. They were excluded because they discontniued the investigation and only baseline data was collected from them. Furthermore, not all subjects in the ITT population answered the QoL questionaire for both products. | Posted | Mean | Standard Deviation | units on a scale | 6 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Compact Catheter | Compact intermittent catheter |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Influenza | Infections and infestations |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pref. Emmanuel Chartier-kastler | Hopital Raymond poincare | +33 1 42 17 71 29 | emmanuel.chartier-kastler@psl.aphp.fr |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Standard care | Device | The coated intermittent catheter normally used by subject |
|
| Copenhagen |
| Denmark |
| CCBR Vejle, Clinical research site, | Vejle | Denmark |
| Hôpital Tenon, Neuro-Urology and perineal explorations department, | Paris | Cedex 20 | France |
| Hôpital Raymond Poincaré, Urology clinic | Garches | 92350 | France |
| Hôpital Léon Berard, Rehabilitation clinic, | Hyères | France |
| Hôpital Henry Gabrielle, Urology clinic, | Saint-Genis-Laval | France |
| University Heidelberg, Neuro-Urology clinic, | Heidelberg | Germany |
| St. Olavs Hospital HF, Neurologi clinic, | Trondheim | Norway |
| Gävle sjukhus, Urology clinic, | Gävle | Sweden |
| Rehab Station Stockholm, | Stockholm | Sweden |
| Lost to Follow-up |
|
| Lack of Efficacy |
|
| Felt unable to empty bladder |
|
| NOT COMPLETED |
|
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Standard Care: Coated intermittent catheter normally used by subject |
|
|
| 3 |
| 123 |
| 16 |
| 123 |
| EG001 | Standard Care | Standard Care: Coated intermittent catheter normally used by subject | 2 | 115 | 14 | 115 |
| Neuropathic pain | Nervous system disorders |
|
| Pleuritis | Respiratory, thoracic and mediastinal disorders |
|
| Pneumopathy | Respiratory, thoracic and mediastinal disorders |
|
| Acute myocardial infarction | Cardiac disorders |
|
| Kidney Stone | Renal and urinary disorders |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders |
|
| Sinusitis | Respiratory, thoracic and mediastinal disorders |
|
| Difficulty breathing | Respiratory, thoracic and mediastinal disorders |
|
| UTI | Infections and infestations |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders |
|
| Cold | Infections and infestations |
|
| Cystitis | Renal and urinary disorders |
|
| Neuropathic pain | Nervous system disorders |
|
| Anal hemorrhoids | Gastrointestinal disorders |
|
| Planned plastic surgery of ulcer | Surgical and medical procedures |
|
| Urethral sensitivity when Catheter removed | Surgical and medical procedures |
|
| Haematuria | Renal and urinary disorders |
|
| Pain in hands | Musculoskeletal and connective tissue disorders |
|
| Abscess tooth and gingival | Infections and infestations |
|
| Insomnia | Nervous system disorders |
|
| Ischial pressure ulcer | Skin and subcutaneous tissue disorders |
|
| Tendinophaty | Nervous system disorders |
|
| Skin herpes | Infections and infestations |
|
| Spasticity of legs | Nervous system disorders |
|
Not provided