Urologic DiseasesIDESONDENCT05313945
Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal
A study testing Passive indwelling urinary catheter removal and Active indwelling catheter removal by a nurse in people with Urologic Diseases, run by Hospices Civils de Lyon at 2 sites in France.
Trial summary
In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urologic Diseases
- What is being tested?
- Passive indwelling urinary catheter removal and Active indwelling catheter removal by a nurse
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesFrance
- Study dates
- 21 Jul 2022to 21 Mar 2027
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male ≥ 18 years old
- With an indwelling urinary catheter placed after any of the following procedures:
- A uro-endoscopic surgery from the list below:
- Endoscopic prostate resection (or transurethral prostate resection).
- Laser prostate enucleation
- Prostate thermotherapy by radiofrequency
Show all 11Show fewer
- A high-intensity focused ultrasound treatment for prostate cancer
- Cervico-prostatic incision or internal urethrotomy
- Endoscopic/Transurethral Resection of Bladder Tumor (TURBT)
- Surgical treatment of bladder stones, ureter stones (rigid ureteroscopy) and kidney stones (flexible ureteroscopy with laser stone fragmentation)
- Patient who has given written consent to participate
Who cannot join
- Patient who is unable to perform intimate hygiene alone in a standing position
- Patient with a painful genital lesion
- Patient with an extended pelvic pathology
- Need to remove the indwelling urinary catheter at the patient's home instead of hospital
- Patient under guardianship or curator
- Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
CHU Grenoble
Grenoble, 38000
Thomas BATARD, MD
- Recruiting
Hôpita Edouard Herriot
Lyon, 69003
Nora JAMALI, Nurse
About this study
Official title: Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse
In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction.
It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial.
- Conditions
- Urologic Diseases
- Being tested
- Passive indwelling urinary catheter removal, Active indwelling catheter removal by a nurse
- Keywords
- bladder catheter
- Medical subject headings
- Urologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Passive indwelling urinary catheter removalProcedure or surgery
After washing the patient's perineal area with water and mild soap, the nurse deflates the indwelling urinary catheter balloon and instructs the patient to take a shower (standing).
During this time, the catheter will fall under gravity.
Active indwelling catheter removal by a nurseProcedure or surgery
After washing the patient's perineal area with water and mild soap, the nurse deflates the balloon and removes the catheter from the urethra by manual traction.
| Study group | Role | What they receive |
|---|---|---|
| Passive indwelling urinary catheter removal | Experimental | The passive indwelling urinary catheter removal takes place due to gravity. Receives: Procedure: Passive indwelling urinary catheter removal |
| Manual indwelling urinary catheter removal | Active comparator | The manual indwelling urinary catheter removal takes place by manual traction by a nurse. Receives: Procedure: Active indwelling catheter removal by a nurse |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient satisfaction score
Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)
Measured: Within one hour after indwelling urinary catheter removal at day 0
Secondary outcomes (4)
The pain experienced by patients
The pain experienced by patients will be measured using a numerical scale (EN) ranging from the minimum value 0 (The better score) to the maximum value 10 (The worse Score)
Measured: Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)
The anxiety experienced by patients
The anxiety experienced by patients will be measured using a numerical scale (EN) ranging from the minimum value 0 (The better score) to the maximum value 10 (The worse Score)
Measured: Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)
Patient satisfaction
Patient satisfaction will be evaluated using a satisfaction questionnaire without score
Measured: at Day 0, at Day 2, at Day 15
Patient satisfaction
Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)
Measured: at Day 2, at Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start21 Jul 2022
- Primary completion21 Mar 2027 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urologic DiseasesStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Camille BENETON, Nurse, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313945
- Sponsor's protocol ID
- 69HCL21_0171
- Acronym
- IDESONDE
- Status last verified
- Mar 2026
- First submitted
- 29 Mar 2022
- Last updated
- 16 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse
- ClinicalTrials.gov ID
- NCT05313945
- Acronym / sponsor ID
- IDESONDE / 69HCL21_0171
- Conditions
- Urologic Diseases
- Keywords
- bladder catheter
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- 21 Jul 2022 (actual)
- Primary completion
- 21 Mar 2027 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 6 Apr 2022 (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.
In usual practice, the removal of the bladder catheter is performed by a nurse a few days after the surgery. The nurse deflates the balloon and removes the catheter from the urethra by manual traction. To date, there are no solid data on the impact of passive catheter removal on patient satisfaction.
It is therefore necessary to estimate the effect on patient satisfaction of active catheter removal by a nurse versus passive catheter removal under gravity. The effect on pain and anxiety will also be compared between the two techniques. The methodology used was that of an open-label randomized controlled trial.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passive indwelling urinary catheter removal | Experimental | Procedure: Passive indwelling urinary catheter removalThe passive indwelling urinary catheter removal takes place due to gravity. |
| Manual indwelling urinary catheter removal | Active comparator | Procedure: Active indwelling catheter removal by a nurseThe manual indwelling urinary catheter removal takes place by manual traction by a nurse. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male ≥ 18 years old
- With an indwelling urinary catheter placed after any of the following procedures:
- Patient who has given written consent to participate
Key exclusion criteria (6 listed)
- Patient who is unable to perform intimate hygiene alone in a standing position
- Patient with a painful genital lesion
- Patient with an extended pelvic pathology
- Need to remove the indwelling urinary catheter at the patient's home instead of hospital
- Patient under guardianship or curator
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 |
|---|---|---|
| Passive indwelling urinary catheter removalAfter washing the patient's perineal area with water and mild soap, the nurse deflates the indwelling urinary catheter balloon and instructs the patient to take a shower (standing). During this time, the catheter will fall under gravity. | Procedure or surgery | Passive indwelling urinary catheter removal |
| Active indwelling catheter removal by a nurseAfter washing the patient's perineal area with water and mild soap, the nurse deflates the balloon and removes the catheter from the urethra by manual traction. | Procedure or surgery | Manual indwelling urinary catheter removal |
Primary outcome
Patient satisfaction score
Time frame: Within one hour after indwelling urinary catheter removal at day 0
Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)
4 secondary outcomes
The pain experienced by patients
Time frame: Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)
The anxiety experienced by patients
Time frame: Prior to catheter removal (within 30 minutes before the start of the procedure) and in the immediate aftermath (within one hour after the removal of the catheter)
Patient satisfaction
Time frame: at Day 0, at Day 2, at Day 15
Patient satisfaction
Time frame: at Day 2, at Day 15
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 16 Mar 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.
Camille BENETON, Nurse principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Passive indwelling urinary catheter removal and Active indwelling catheter removal by a nurse in people with Urologic Diseases, run by Hospices Civils de Lyon at 2 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 11 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 16 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Nora JAMALI, Nurse (04 72 11 74 94, nora.jamali@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient satisfaction score (time frame: Within one hour after indwelling urinary catheter removal at day 0). 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 16 Mar 2026.