NCT05313945 Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal
| NCT ID | NCT05313945 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Hospices Civils de Lyon |
| Condition | Urologic Diseases |
| Study Type | INTERVENTIONAL |
| Enrollment | 160 participants |
| Start Date | 2022-07-21 |
| Primary Completion | 2027-03-21 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 160 participants in total. It began in 2022-07-21 with a primary completion date of 2027-03-21.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Camille BENETON, Nurse
PRINCIPAL INVESTIGATOR
Hospices Civils de Lyon
Frequently Asked Questions
Who can join the NCT05313945 clinical trial?
This trial is open to male participants only, aged 18 Years or older, studying Urologic Diseases. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05313945 currently recruiting?
Yes, NCT05313945 is actively recruiting participants. Contact the research team at nora.jamali@chu-lyon.fr for enrollment information.
Where is the NCT05313945 trial being conducted?
This trial is being conducted at Grenoble, France, Lyon, France.
Who is sponsoring the NCT05313945 clinical trial?
NCT05313945 is sponsored by Hospices Civils de Lyon. The principal investigator is Camille BENETON, Nurse at Hospices Civils de Lyon. The trial plans to enroll 160 participants.