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Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal

Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05313945
Acronym
IDESONDE
Enrollment
160
Registered
2022-04-06
Start date
2022-07-21
Completion date
2027-03-21
Last updated
2026-03-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urologic Diseases

Keywords

bladder catheter

Brief 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. 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.

Interventions

PROCEDUREPassive indwelling urinary catheter removal

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.

PROCEDUREActive indwelling catheter removal by a nurse

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.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Male ≥ 18 years old 2. 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 * 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) 3. Patient who has given written consent to participate

Exclusion criteria

1. Patient who is unable to perform intimate hygiene alone in a standing position 2. Patient with a painful genital lesion 3. Patient with an extended pelvic pathology 4. Need to remove the indwelling urinary catheter at the patient's home instead of hospital 5. Patient under guardianship or curator 6. Patient unable to understand the objectives of the study or unwilling to comply with postoperative instructions

Design outcomes

Primary

MeasureTime frameDescription
Patient satisfaction scoreWithin one hour after indwelling urinary catheter removal at day 0Patient satisfaction score using a numerical rating scale (NRS) from the minimum value 0 (The worse score) to the maximum value 10 (The better Score)

Secondary

MeasureTime frameDescription
The pain experienced by patientsPrior 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 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)
The anxiety experienced by patientsPrior 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 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)
Patient satisfactionat Day 0, at Day 2, at Day 15Patient satisfaction will be evaluated using a satisfaction questionnaire without score

Countries

France

Contacts

CONTACTNora JAMALI, Nurse
nora.jamali@chu-lyon.fr04 72 11 74 94
CONTACTMarjolaine Beaudoin, ARC
marjolaien.beaudoin@chu-lyon.fr04 72 11 74 94
PRINCIPAL_INVESTIGATORCamille BENETON, Nurse

Hospices Civils de Lyon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 17, 2026