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

Study Overview
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Brief Summary
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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.

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

Conditions
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Urologic Diseases

Intervention / Treatment
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* Procedure: Passive indwelling urinary catheter removal
* Procedure: Active indwelling catheter removal by a nurse


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Passive indwelling urinary catheter removal<br>The passive indwelling urinary catheter removal takes place due to gravity. | Procedure: Passive indwelling urinary catheter removal<br>* 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.<br>|
| Active Comparator: Manual indwelling urinary catheter removal<br>The manual indwelling urinary catheter removal takes place by manual traction by a nurse. | Procedure: Active indwelling catheter removal by a nurse<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Within one hour after indwelling urinary catheter removal at day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 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) | 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 | 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) | at Day 2, at Day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder catheter