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| Name | Class |
|---|---|
| Lund University | OTHER |
| Vinnova | OTHER_GOV |
| Innovation Skåne AB/ Sweden | UNKNOWN |
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A randomized, open label, controlled, parallel group study to investigate difference between regional standard procedure and a novel modified procedure (using an additional novel device to facilitate gel installation) for changing long-term indwelling urinary catheters.
This is a randomized, open label, controlled, parallel group study, which comprises one visit that includes: assessment for eligibility, randomization to one of two treatment alternatives, followed by the actual intervention and evaluation of outcomes.
The interventions are either change of catheter according to the regional standard procedure (the comparator group) or change of catheter with the additional use of the novel device to facilitate gel instillation and a slightly modified procedure (the experimental group).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Novel gel installation device procedure | Experimental | Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device procedure |
|
| Standard procedure | Active Comparator | Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Novel gel installation device procedure | Device | Catheter change with novel device Each subject will undergo catheter change with novel gel instillation device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment duration (min) | Treatment duration for procedure | During procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Patient's perceived pain (NRS scale) | Patient's perceived pain estimated by patient using a numerical rating scale (NRS-scale) | During intervention |
| Number of gel syringes used | Number of pre-filled gel syringes used during the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] | Incidence of Treatment-Emergent Adverse Events found during procedure | During intervention |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ulf Malmqvist, PhD | Clinical Studies Sweden - Forum South | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skåne University Hospital - Urology clinic - Homecare unit | Lund | 22185 | Sweden |
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Arm 1: Experimental: Novel device: Assigned Interventions: Catheter change with novel device. Each subject will undergo catheter change with novel gel instillation device.
Arm 2: Comparator: Standard procedure: Assigned Interventions: Catheter change with standard procedure. Each subject will undergo catheter change with standard procedure.
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Open label
| Standard procedure | Device | Catheter change with standard procedure Each subject will undergo catheter change with standard procedure |
|
| During intervention |
| ID | Term |
|---|---|
| D016055 | Urinary Retention |
| D014549 | Urinary Incontinence |
| ID | Term |
|---|---|
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D059411 | Lower Urinary Tract Symptoms |
| D020924 | Urological Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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