Intermittent Urethral Catheterization, Prostatic Hyperplasia, Surgical Procedures, Urinary Catheterization, Urinary Retention, Urinary Tract Infections
Conditions
Keywords
BPH, ICSC, IDC, Urinary Tractus Infection
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREICSC
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.
PROCEDUREIDC
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.
Sponsors
University Hospital, Bordeaux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Intervention model description
Multicentre, randomised, open-label, two-arm clinical superiority trial
Eligibility
Sex/Gender
MALE
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Indication for surgical management of BPH; * Patient affiliated with or a beneficiary of a social security scheme; * Signed informed consent for participation in the study.
Exclusion criteria
* 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); * Patient who had urine drainage by suprapubic catheter * Patient with motor, neurological, anatomical, or cognitive difficulties preventing the education or learning of ICSC; * Patient contraindicated for surgical management of their BPH; * Patient unable to understand the research documents and provide informed consent; * Persons subject to legal protection measures or placed under judicial protection.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery. | 7 Days before BPH surgery & 7 days after BPH 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of postoperative complications according to the Clavien-Dindo classification | 1 Month & 3 Months | 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 | From the date of BPH surgery to the date of definitive catheter removal, assessed up to 30 days post-surgery | The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge |
| Duration of postoperative hospitalization | From the date of BPH surgery to the date of hospital discharge, assessed up to 30 days post-surgery | 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 | At hospital discharge, assessed up to 7 days post-surgery | Rate of successful spontaneous voiding recovery is evaluated in percentage of randomized patients in each group who resumed spontaneous voiding upon catheter removal. |
| Patient quality of life (1) | Baseline; 1 month post surgery; 3 Months post-surgery | 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. |
| Patient quality of life (2) | Baseline; 1 month post surgery; 3 Months post-surgery | 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. |
| Patient quality of life (3) | Baseline; 1 month post surgery; 3 Months post-surgery | 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. |
| 30-day readmission rate, defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery | 1 month post surgery | The readmission rate is defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery |
| ICSC learning success rate | within 3 months before surgery | The ICSC learning success rate is evaluated in the percentage of patients in the ICSC group who successfully performed self-catheterization |
Countries
France
Contacts
CONTACTClément KLEIN, Dr
CONTACTGrégoire ROBERT, Pr.
Outcome results
None listed