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

April 21, 2026 updated by: University Hospital, Bordeaux

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

106

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Angers, France
        • CHU d'Angers
        • Principal Investigator:
          • Souhil LEBDAI, Dr
        • Contact:
      • Bourdeaux, France
        • Centre d'Urologie Bordeaux Saint Gatien
        • Contact:
        • Principal Investigator:
          • Clément MICHIELS, Dr
      • Paris, France
        • APHP la Pitié-Salpêtrière
        • Contact:
        • Principal Investigator:
          • Ugo PINAR, Dr
      • Périgueux, France
        • Hôpital Privé Francheville
        • Principal Investigator:
          • Richard MALLET, Dr
        • Contact:
      • Toulouse, France
        • CHU de Toulouse Rangueil
        • Contact:
        • Principal Investigator:
          • Xavier GAME, Pr

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intermittent Clean Self-Catheterization (ICSC)
ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves.
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 tolerance and effectiveness of the procedure.
Other Names:
  • Intermittent Clean Self-Catheterization
Active Comparator: Indwelling Catheter (IDC)
IDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder.
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.
Other Names:
  • Indwelling Catheter

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
7 Days before BPH surgery & 7 days after BPH surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
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
The duration of postoperative hospitalization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
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
Rate of successful spontaneous voiding recovery is evaluated in percentage of randomized patients in each group who resumed spontaneous voiding upon catheter removal.
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
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.
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
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.
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
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.
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
The readmission rate is defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery
1 month post surgery
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
within 3 months before surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 24, 2026

Primary Completion (Estimated)

April 24, 2028

Study Completion (Estimated)

April 24, 2028

Study Registration Dates

First Submitted

April 3, 2026

First Submitted That Met QC Criteria

April 21, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2025/20

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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