Clinical trial NCT05313945: Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal
Official title: Multicenter, Randomized, Controlled Trial Evaluating Patient Satisfaction After Passive Bladder Catheter Removal Following Urological Surgery Compared to Active Removal by a Nurse
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urologic Diseases
Keywords: bladder catheter
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2022-04-06
Enrollment: 160
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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

Primary outcomes:
measure: Patient satisfaction score
timeFrame: Within one hour after indwelling urinary catheter removal at day 0
Secondary outcomes:
measure: The pain experienced by patients
timeFrame: 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)
measure: The anxiety experienced by patients
timeFrame: 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)
measure: Patient satisfaction
timeFrame: at Day 0, at Day 2, at Day 15
measure: Patient satisfaction
timeFrame: at Day 2, at Day 15
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble
city: Lyon
country: France
facility: Hôpita Edouard Herriot
Study officials:
affiliation: Hospices Civils de Lyon
name: Camille BENETON, Nurse
role: PRINCIPAL_INVESTIGATOR
References: