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

Not Applicable

Recruiting

• Conditions: Urologic Diseases

• Registration Number: NCT05313945
• Lead Sponsor: Hospices Civils de Lyon

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-29
• Study First Submitted QC: 2022-03-29
• Study First Posted: 2022-04-06
• Study Start: 2022-07-21
• Status Verified: 2023-07
• Last Update Submitted: 2024-06-27
• Last Update Posted: 2024-06-28
• Primary Completion: 2024-08-05
• Study Completion: 2024-08-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 160

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Patient satisfaction score	Within one hour after indwelling urinary catheter removal at day 0	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)

Secondary Outcome Measures

Name	Time	Method
The pain experienced by patients	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 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)
Patient satisfaction	at Day 2, at Day 15	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)
The anxiety experienced by patients	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 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)

Trial Locations

Locations (2)

CHU Grenoble; 🇫🇷 Grenoble, France

Hôpita Edouard Herriot; 🇫🇷 Lyon, France