Prostatic HyperplasiaCATHETERSNCT07555964
Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.
A study testing ICSC and IDC in people with Prostatic Hyperplasia and Urinary Retention, run by University Hospital, Bordeaux at 5 sites in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostatic Hyperplasia, Urinary Retention, Urinary Catheterization
- What is being tested?
- ICSC and IDC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 5 sitesFrance
- Study dates
- 24 Apr 2026to 24 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites
CHU d'Angers
Angers
Souhil LEBDAI, Dr, 0033 2 41 35 35 09, SoLebdai@chu-angers.fr
Souhil LEBDAI, Dr
Centre d'Urologie Bordeaux Saint Gatien
Bourdeaux
Clément MICHIELS, Dr, 0033 5 56 11 61 44, clement.michiels@gmail.com
Clément MICHIELS, Dr
APHP la Pitié-Salpêtrière
Paris
Ugo PINAR, 0033 1 84 82 80 63, ugo.pinar@aphp.fr
Ugo PINAR, Dr
Hôpital Prive Francheville
Périgueux
Richard MALLET, Dr, 0033 6 22 47 16 45, richard.mallet1@gmail.com
Richard MALLET, Dr
CHU de Toulouse Rangueil
Toulouse
Xavier GAME, Pr, 0033 5 61 32 31 06, game.x@chu-toulouse.fr
Xavier GAME, Pr
About this study
Official title: 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.
Read the 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.
- Conditions
- Prostatic Hyperplasia, Urinary Retention, Urinary Catheterization, Intermittent Urethral Catheterization, Urinary Tract Infections, Surgical Procedures
- Being tested
- ICSC, IDC
- Keywords
- BPH, ICSC, IDC, Urinary Tractus Infection
- Medical subject headings
- Prostatic Hyperplasia, Urinary Retention, Urinary Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ICSCProcedure or surgery
Also called Intermittent Clean Self-Catheterization
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.
IDCProcedure or surgery
Also called Indwelling Catheter
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.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent Clean Self-Catheterization (ICSC) | Experimental | ICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves. Receives: 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. Receives: Procedure: IDC |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 7 Days before BPH surgery & 7 days after BPH surgery
Secondary outcomes (9)
Rate of postoperative complications according to the Clavien-Dindo classification
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)
Measured: 1 Month & 3 Months
Duration of postoperative catheterization
The duration of postoperative catheterization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
Measured: From the date of BPH surgery to the date of definitive catheter removal, assessed up to 30 days post-surgery
Duration of postoperative hospitalization
The duration of postoperative hospitalization is measured in days from surgery to definitive catheter removal, assessed at hospital discharge
Measured: 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
Rate of successful spontaneous voiding recovery is evaluated in percentage of randomized patients in each group who resumed spontaneous voiding upon catheter removal.
Measured: At hospital discharge, assessed up to 7 days post-surgery
Patient quality of life (1)
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.
Measured: Baseline; 1 month post surgery; 3 Months post-surgery
Patient quality of life (2)
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.
Measured: Baseline; 1 month post surgery; 3 Months post-surgery
Patient quality of life (3)
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.
Measured: 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
The readmission rate is defined as the percentage of randomized patients in each group readmitted to hospital within 30 days after surgery
Measured: 1 month post surgery
ICSC learning success rate
The ICSC learning success rate is evaluated in the percentage of patients in the ICSC group who successfully performed self-catheterization
Measured: within 3 months before surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2026
- Study start24 Apr 2026 (estimated)
- Primary completion24 Apr 2028 (estimated)
- Study completion24 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostatic HyperplasiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Multicentre, randomised, open-label, two-arm clinical superiority trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07555964
- Sponsor's protocol ID
- CHUBX 2025/20
- Acronym
- CATHETERS
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2026
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Clean Intermittent Self-catheterization and Indwelling Catheterization for the Management of Urinary Retention Before BPH Surgery.l
- ClinicalTrials.gov ID
- NCT07555964
- Acronym / sponsor ID
- CATHETERS / CHUBX 2025/20
- Conditions
- Prostatic Hyperplasia, Urinary Retention, Urinary Catheterization, Intermittent Urethral Catheterization, Urinary Tract Infections, Surgical Procedures
- Keywords
- BPH, ICSC, IDC, Urinary Tractus Infection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 Apr 2026 (estimated)
- Primary completion
- 24 Apr 2028 (estimated)
- Study completion
- 24 Apr 2028 (estimated)
- First posted
- 29 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Multicentre, randomised, open-label, two-arm clinical superiority trial
| Arm | Type | Receives |
|---|---|---|
| Intermittent Clean Self-Catheterization (ICSC) | Experimental | Procedure: ICSCICSC is a technique of intermittent bladder emptying performed several times a day by the patient themselves. |
| Indwelling Catheter (IDC) | Active comparator | Procedure: IDCIDC is a continuous bladder drainage technique that allows for constant urine removal via a catheter left in place in the bladder. |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ICSCAlso: Intermittent Clean Self-CatheterizationICSC 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. | Procedure or surgery | Intermittent Clean Self-Catheterization (ICSC) |
| IDCAlso: Indwelling CatheterIDC 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. | Procedure or surgery | Indwelling Catheter (IDC) |
Primary outcome
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).
9 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ICSC and IDC in people with Prostatic Hyperplasia and Urinary Retention, run by University Hospital, Bordeaux at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clément KLEIN, Dr (0033 5 56 79 55 97, clement.klein@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.