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

Urologic Diseases Clinical Trial

— IDESONDE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05313945
• Other study ID #: 69HCL21_0171
• Status: Recruiting
• Phase: N/A
• Start date: July 21, 2022
• Est. completion date: August 5, 2024

Study information

• Verified date: July 2023
• Source: Hospices Civils de Lyon
• Contact: Camille BENETON, Nurse
• Phone: 0472119111
• Email: camille.beneton[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: August 5, 2024
• Est. primary completion date: August 5, 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Urologic Diseases

Intervention

Procedure:
• Passive 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.
• Active 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.

Locations

Country	Name	City	State
France	CHU Grenoble	Grenoble
France	Hôpita Edouard Herriot	Lyon

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	Patient satisfaction	Patient satisfaction will be evaluated using a satisfaction questionnaire without score	at Day 0, at Day 2, at Day 15
Secondary	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