Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal (IDESONDE)

Civil Hospices of Lyon

Status: Enrolling

Conditions: Urologic Diseases

Treatments: Procedure: Active indwelling catheter removal by a nurse; Procedure: Passive indwelling urinary catheter removal

Study type: Interventional

Funder types: Other

Identifiers

NCT05313945

69HCL21_0171

Details and patient eligibility

About

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.

Enrollment: 160 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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160 participants in 2 patient groups

Passive indwelling urinary catheter removal

Experimental group

Description:

The passive indwelling urinary catheter removal takes place due to gravity.

Treatment:

Procedure: Passive indwelling urinary catheter removal

Manual indwelling urinary catheter removal

Active Comparator group

Description:

The manual indwelling urinary catheter removal takes place by manual traction by a nurse.

Treatment:

Procedure: Active indwelling catheter removal by a nurse