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

NCT07555964 | Not Yet Recruiting DMC

• 1 other identifier: CHUBX 2025/20
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostatic Hyperplasia; Urinary Retention; Urinary Catheterization; Intermittent Urethral Catheterization; Urinary Tract Infections; Surgical Procedures

Keywords

BPH; ICSC; IDC; Urinary Tractus Infection

Outcome Measures

Primary Outcomes (1)

• 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).

  7 Days before BPH surgery & 7 days after BPH surgery

Secondary Outcomes (9)

• Rate of postoperative complications according to the Clavien-Dindo classification

  1 Month & 3 Months

• Duration of postoperative catheterization

  From the date of BPH surgery to the date of definitive catheter removal, assessed up to 30 days post-surgery

• Duration of postoperative hospitalization

  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

  At hospital discharge, assessed up to 7 days post-surgery

• Patient quality of life (1)

  Baseline; 1 month post surgery; 3 Months post-surgery

Study Arms (2)

Intermittent Clean Self-Catheterization (ICSC)

EXPERIMENTAL

ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves.

Procedure: ICSC

Indwelling Catheter (IDC)

ACTIVE COMPARATOR

IDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder.

Procedure: IDC

Interventions

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.

Also known as: Intermittent Clean Self-Catheterization

Intermittent Clean Self-Catheterization (ICSC)

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.

Also known as: Indwelling Catheter

Indwelling Catheter (IDC)

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (5)

CHU d'Angers

Angers, France

Location

Centre d'Urologie Bordeaux Saint Gatien

Bourdeaux, France

Location

APHP la Pitié-Salpêtrière

Paris, France

Location

Hôpital Prive Francheville

Périgueux, France

Location

CHU de Toulouse Rangueil

Toulouse, France

Location

MeSH Terms

Conditions

Prostatic Hyperplasia; Urinary Retention; Urinary Tract Infections

Interventions

Intermittent Urethral Catheterization; Catheters, Indwelling

Condition Hierarchy (Ancestors)

Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Infections

Intervention Hierarchy (Ancestors)

Urinary Catheterization; Catheterization; Therapeutics; Investigative Techniques; Catheters; Equipment and Supplies

Central Study Contacts

Clément KLEIN, Dr

CONTACT

0033 5 56 79 55 97; clement.klein@chu-bordeaux.fr

Grégoire ROBERT, Pr.

CONTACT

0033 5 56 79 55 97; gregoire.robert@chu-bordeaux.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Multicentre, randomised, open-label, two-arm clinical superiority trial

Study Record Dates

• First Submitted: April 3, 2026
• First Posted: April 29, 2026
• Study Start: April 24, 2026
• Primary Completion (Estimated): April 24, 2028
• Study Completion (Estimated): April 24, 2028
• Last Updated: April 29, 2026

Record last verified: 2025-04

Locations

FR (5)