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NCT Number: NCT07555964

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Intermittent Clean Self-Catheterization

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.

Other names: Indwelling Catheter

Primary outcomes

  1. 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

    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 outcomes

  1. Rate of postoperative complications according to the Clavien-Dindo classification

    Time frame: 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)

  2. 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

    The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge

  3. 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

    The duration of postoperative hospitalization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge

  4. Rate of successful spontaneous voiding recovery

    Time frame: 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.

  5. Patient quality of life (1)

    Time frame: 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.

  6. Patient quality of life (2)

    Time frame: 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.

  7. Patient quality of life (3)

    Time frame: 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.

  8. 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

    The readmission rate is defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery

  9. ICSC learning success rate

    Time frame: 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

Study contacts

Contact information is provided by the study sponsor or research team.

Clément KLEIN, Dr

CONTACT

[email protected]

0033 5 56 79 55 97

Grégoire ROBERT, Pr.

CONTACT

[email protected]

0033 5 56 79 55 97

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Official study title

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

Acronym: CATHETERS

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 29, 2026
Registry last updated
Apr 29, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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