Postoperative Urinary Retention (POUR) Clinical Trial
— POUR-RCTOfficial title:
Urinary Bladder Catheterization in Fast-track Hip and Knee Arthroplasty - What is the Optimal Bladder Volume? A Randomized, Controlled Study
Approximately 40 % of all patients undergoing fast-track total hip or knee arthroplasty needs intermittent bladder catheterization after surgery, as they are transient incapable of voluntary bladder emptying (postoperative urinary retention - POUR). The currently used interventional threshold for urinary bladder catheterization are a bladder volume of approximately 500 ml., but no evidence exists for this threshold. At the same time, the current knowledge suggest, that a bladder volume up to 1000 ml. for 2-4 hours are safe in humans, and as the use of urinary bladder catheterization are increasing the risk of complications, the investigators are hypothesizing that increasing the interventional threshold for urinary bladder catheterization after fast-track total hip or knee arthroplasty, will reduce the number of patients needing urinary bladder catheterization, without increasing the incidence of urological complications - including urinary tract infections.
| Status | Completed |
| Enrollment | 800 |
| Est. completion date | May 2015 |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 125 Years |
| Eligibility |
Inclusion Criteria: - planned for elective total hip or knee arthroplasty - given written informed consent for participation Exclusion Criteria: - can't co-operate to participation - can't speak or understand danish - preoperative use of urinary bladder catheterization - using haemodialysis - previous cystectomy - need for permanent urinary bladder catheter during surgery (decided by anaesthesiologist and/or surgeon) - Pregnant or given birth within the last 6 months |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Denmark | Aalborg University Hospital, Farsoe | Farsoe | |
| Denmark | Department of Orthopaedics, Gentofte University Hospital | Hellerup | |
| Denmark | Department of Orthopaedics, Vejle Hospital | Vejle |
| Lead Sponsor | Collaborator |
|---|---|
| Rigshospitalet, Denmark | Lundbeck Foundation |
Denmark,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Other | Time from last preoperative micturition to end of surgery. | Patients will be follwed from their last preoperative micturition to end of surgery. Expectably within a mean period of two hours. | No | |
| Other | Time from last preoperative micturitions to first postoperative bladder catheterization (if relevant). | Patients will be follwed from their last preoperative micturition to their first postoperative bladder catheterization (if relevant). Expectably within a mean period of six to eight hours. | No | |
| Other | Time from last preoperative micturition to first postoperative, voluntary micturition. | Patients will be follwed from their last preoperative micturition to their first postoperative, voluntary micturition. Expectably within a mean period of fourteen hours. | No | |
| Other | Time from end of surgery to first postoperative bladder catheterization (if relevant). | Patients will be follwed from end of surgery to their first postoperative bladder catheterization (if relevant). Expectably within a mean period of four to six hours. | No | |
| Other | Time from end of surgery to first postoperative, voluntary micturition. | Patient will be followed from end of surgery to their first postoperative, voluntary micturition. Expectably within a mean period of twelve hours. | No | |
| Primary | Number of patients receiving postoperative urinary bladder catheterization | Patients will be followed from end of surgery to their first voluntary micturition, expectably within a mean period of twelve hours | No | |
| Secondary | Incidence of urinary tract infections | within the first 30 days after surgery | Yes | |
| Secondary | Number of voiding difficulties acquired postoperatively | within the first 30 days postoperatively | Yes | |
| Secondary | Number of readmissions due to urological issues (including urosepsis) | Within the first 30 days postoperatively | Yes |