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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
106
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.
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.
CHU d'Angers
Angers, France
Centre d'Urologie Bordeaux Saint Gatien
Bourdeaux, France
APHP la Pitié-Salpêtrière
Paris, France
Hôpital Prive Francheville
Périgueux, France
CHU de Toulouse Rangueil
Toulouse, France
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).
Time frame: 7 Days before BPH surgery & 7 days after BPH surgery
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)
Time frame: 1 Month & 3 Months
Duration of postoperative catheterization
The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: within 3 months before surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.