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| Name | Class |
|---|---|
| University of Eastern Finland | OTHER |
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Arthroplasty increases the risk of postoperative urinary retention. Treatment of postoperative urinary retention is indwelling or intermittent catheterization. The need for catheterization is most commonly determined with an ultrasound scanner. Catheterization increases the risk of urinary tract infection, which may further lead to haematogenic infection of the artificial joint. There is no evidence of an optimal way to monitor the onset of spontaneous urination.
The aim of the study is to determine whether monitoring the onset of spontaneous urination after fast track knee arthroplasty is safe based on symptoms alone without ultrasound monitoring.
Adult patients undergoing knee arthroplasty will be recruited to this study. Participants will be randomized to the ultrasound monitoring group or the symptoms alone group. In the symptoms alone group, urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis or if spontaneous voiding has not started 10 hours after the spinal anesthesia. Symptoms that indicate catheterization are lower abdominal pain or need to void. In the ultrasound group, urinary retention is monitored according to current practice with an ultrasound scanner and the patient is catheterized if residual urine exceeds 800 ml or if the patient is symptomatic.
The primary outcome variable is the change in IPSS score from the baseline to 3 months after the procedure. The baseline score is evaluated preoperatively.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ultrasound monitoring group | Active Comparator | In the ultrasound group, urinary retention is monitored, according to current practice, with an ultrasound scanner and the patient is catheterized if necessary, if residual urine exceeds 800 ml, or if the patient is symptomatic. |
|
| Symptoms alone group | Active Comparator | Urination is monitored by asking at regular intervals about the onset of spontaneous urination and the patient is catheterized only on a symptomatic basis. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Catheterization based on ultrasound | Other | Bladder volume ultrasound |
| |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) | IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome. | 3 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| International Prostate Symptom Score (IPSS) | IPSS questionnaire compared to IPSS before surgery. The minimum score is 0. The maximum score is 35. Higher scores mean a worse outcome. | 12 months after surgery |
| Incidence of urinary complications |
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Inclusion Criteria:
Exclusion Criteria:
in 1:1 ratio. Participant eligibility is based on self-representation of gender identity.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Juha Paloneva, professor | Contact | 014 269 1680 | juha.paloneva@ksshp.fi | |
| Juho Sippola, MD | Contact | 014 269 1908 | juho.sippola@ksshp.fi |
| Name | Affiliation | Role |
|---|---|---|
| Juha Paloneva, professor | Chief medical director | Principal Investigator |
| Heikki Seikkula, PhD | Investigator | Study Chair |
| Juho Sippola, MD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Central Finland Hospital Nova | Recruiting | Jyväskylä | 40620 | Finland |
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open label
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| Catheterization based on evaluation of symptoms |
| Other |
Ask for symptoms: Need to urinate, lower abdominal pain |
|
Incidence of urinary complications
| 3 months after surgery |
| Health-related quality of life (15D) score | Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome. | 3 months after surgery |
| Incidence of urinary complications | Incidence of urinary complications | 12 months after surgery |
| Health-related quality of life (15D) score | Health-related quality of life(15D) score compared to 15D score before surgery. The minimum score is 0. The maximum score is 1. Higher scores mean a better outcome. | 12 months after surgery |
| Investigator |
| Study Chair |
| Konsta Pamilo, PhD | Investigator | Study Chair |
| Jonne Ã…kerla, MD | Investigator | Study Chair |
| Aleksi Reito, PhD | Investigator | Study Chair |
| Pirkko Kinnunen | Investigator | Study Chair |