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.
Men over 50 years old;
Confirmed diagnosis of benign prostatic hyperplasia (BPH);
Prostate volume greater than 40 grams;
Presence of acute urinary retention with failure to wean from the catheter despite medical treatment with alpha-blocker for at least 48 hours
Patient with a history of prostate surgery (including BPH surgery), prostatic artery embolization or Urolift implant placement are not considered a history of prostate surgery;
Patient with symptomatic urethral stricture;
Patient with a bladder emptying disorder of neurogenic origin;
Patient with an anatomical contraindication to ICSC (urethral stricture, false urethral route);
Parallel
ICSC
Procedure/SurgeryICSC 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
Procedure/SurgeryIDC 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.
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).
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)
Duration of postoperative catheterization
The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
Duration of postoperative hospitalization
The duration of postoperative hospitalization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
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.
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