Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.

Official title

Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.l

Overview

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

• Procedure ICSC
  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 t
• Procedure IDC
  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.

Primary outcome measures

• Occurrence of an infection or infectious complication within 7 days before and 7 days after surgery. [Time frame: 7 Days before BPH surgery & 7 days after BPH surgery]

Secondary outcome measures (9)

• Rate of postoperative complications according to the Clavien-Dindo classification [Time frame: 1 Month & 3 Months]
• Duration of postoperative catheterization [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 [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 [Time frame: At hospital discharge, assessed up to 7 days post-surgery]
• Patient quality of life (1) [Time frame: Baseline; 1 month post surgery; 3 Months post-surgery]
• Patient quality of life (2) [Time frame: Baseline; 1 month post surgery; 3 Months post-surgery]
• Patient quality of life (3) [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 [Time frame: 1 month post surgery]
• ICSC learning success rate [Time frame: within 3 months before surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

France · 5 centers

• CHU d'Angers — Angers
• Centre d'Urologie Bordeaux Saint Gatien — Bourdeaux
• APHP la Pitié-Salpêtrière — Paris
• Hôpital Prive Francheville — Périgueux
• CHU de Toulouse Rangueil — Toulouse

Identifiers

NCT: NCT07555964 · CHUBX 2025/20

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗