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The CATHETERS trial is a multicenter, randomized, open-label superiority study comparing two methods of managing urinary retention before surgery for benign prostatic hyperplasia (BPH): clean intermittent self-catheterization (ICSC) versus indwelling catheter (IDC). The primary objective is to determine whether ICSC reduces the occurrence of infectious complications (urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis) compared to IDC in men awaiting BPH surgery. A total of 106 patients will be enrolled across multiple centers in France, with follow-up extending to three months after surgery.
Acute urinary retention (AUR) is a frequent complication of benign prostatic hyperplasia (BPH), a condition highly prevalent in older men. The standard management of AUR involves placement of an indwelling catheter (IDC) until surgical treatment can be performed. However, the presence of an IDC is associated with inevitable bacterial colonization of the urinary tract, with the risk increasing by 5-10% per day and reaching 100% after one month. This colonization leads to a higher rate of perioperative infectious complications, increased antibiotic consumption, and prolonged hospitalization. Preliminary retrospective data from our team, comparing 31 ICSC patients to 28 IDC patients, demonstrated significant advantages of ICSC: shorter postoperative catheterization (1 vs. 2.5 days; p < 0.001), better spontaneous voiding recovery (93.5% vs. 64.3%; p < 0.001), less bacterial colonization (51.6% vs. 100%; p < 0.001), and fewer postoperative complications (13% vs. 50%; p < 0.001). Despite these promising results, no randomized trial has been conducted to confirm these findings. This is a multicenter, randomized, open-label, two-arm superiority trial. Eligible patients with AUR due to BPH who fail catheter weaning despite alpha-blocker therapy are randomized to either ICSC (Arm A) or IDC (Arm B) while awaiting BPH surgery. Follow-up includes preoperative assessments, perioperative data collection including urine cultures and antibiotic use within seven days before and after surgery, a telephone consultation at one month, and a final in-person evaluation at three months post-surgery to assess voiding recovery, complications, quality of life, and hospitalization duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Clean Self-Catheterization (ICSC) | Experimental | ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves. |
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| Indwelling Catheter (IDC) | Active Comparator | IDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICSC | Procedure | ICSC consists of temporary urinary drainage performed by the patient themselves, following therapeutic education provided by a trained nurse. Patients use sterile, single-use catheters to empty their bladder 5 to 6 times a day. This method reduces the risk of infectious complications associated with indwelling catheters, while maintaining a good level of patient autonomy and a satisfactory quality of life. The necessary equipment is provided, and regular follow-ups are organised to monitor the tolerance and effectiveness of the procedure. |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery. | Evaluation of the occurrence of an infection or infectious complication within 7 days before and after surgery (including urinary bacterial colonization requiring antibiotic therapy, urinary tract infection, or urosepsis), assessed during the perioperative period (7 days before to 7 days after BPH surgery). | 7 Days before BPH surgery & 7 days after BPH surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of postoperative complications according to the Clavien-Dindo classification | The Clavien Dindo Classification is used to rank the severity of a surgical complication. It is based on the type of therapy needed to correct the complication. The scale consists of several grades (Grade I, II, IIIa, IIIb, IVa, IVb and V) | 1 Month & 3 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clément KLEIN, Dr | Contact | 0033 5 56 79 55 97 | clement.klein@chu-bordeaux.fr | |
| Grégoire ROBERT, Pr. | Contact | 0033 5 56 79 55 97 | gregoire.robert@chu-bordeaux.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU d'Angers | Angers | France |
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Multicentre, randomised, open-label, two-arm clinical superiority trial
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| IDC | Procedure | IDC involves inserting a urinary catheter connected to a continuous drainage system, which is left in place until surgery. The method is simple to perform and widely used in cases of acute urinary retention. However, it is associated with an increased risk of bacterial colonisation and urinary tract infections, particularly when the catheter is left in place for a prolonged period. |
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| Duration of postoperative catheterization |
The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge |
| From the date of BPH surgery to the date of definitive catheter removal, assessed up to 30 days post-surgery |
| Duration of postoperative hospitalization | The duration of postoperative hospitalization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge | From the date of BPH surgery to the date of hospital discharge, assessed up to 30 days post-surgery |
| Rate of successful spontaneous voiding recovery | Rate of successful spontaneous voiding recovery is evaluated in percentage of randomized patients in each group who resumed spontaneous voiding upon catheter removal. | At hospital discharge, assessed up to 7 days post-surgery |
| Patient quality of life (1) | The patient quality of life is evaluated using The King's Health Questionnaire (KHQ) : disease-specific, self-administered questionnaire, assessed by scores range from 0 to 100 for each domain; higher scores indicate greater symptom burden and poorer quality of life. | Baseline; 1 month post surgery; 3 Months post-surgery |
| Patient quality of life (2) | The patient quality of life is evaluated using The IIEF-5 Questionnaire ( 5 items): International Index of Erectile Function, assessed by scores range from 5 to 25; higher scores indicate better erectile function. | Baseline; 1 month post surgery; 3 Months post-surgery |
| Patient quality of life (3) | The patient quality of life is evaluated using The IPSS questionnaire (The International Prostate Symptom Score), assessed by Scores range from 0 to 35; higher scores indicate more severe lower urinary tract symptoms. | Baseline; 1 month post surgery; 3 Months post-surgery |
| 30-day readmission rate, defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery | The readmission rate is defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery | 1 month post surgery |
| ICSC learning success rate | The ICSC learning success rate is evaluated in the percentage of patients in the ICSC group who successfully performed self-catheterization | within 3 months before surgery |
| Centre d'Urologie Bordeaux Saint Gatien | Bourdeaux | France |
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| APHP la Pitié-Salpêtrière | Paris | France |
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| Hôpital Prive Francheville | Périgueux | France |
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| CHU de Toulouse Rangueil | Toulouse | France |
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| ID | Term |
|---|---|
| D011470 | Prostatic Hyperplasia |
| D016055 | Urinary Retention |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D011469 | Prostatic Diseases |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D057928 | Intermittent Urethral Catheterization |
| D002408 | Catheters, Indwelling |
| ID | Term |
|---|---|
| D014546 | Urinary Catheterization |
| D002404 | Catheterization |
| D013812 | Therapeutics |
| D008919 | Investigative Techniques |
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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