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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urologic Diseases
• Intervention / Treatment: Procedure: Passive indwelling urinary catheter removal; Procedure: Active indwelling catheter removal by a nurse

• Study Type: Interventional
• Enrollment (Estimated): 160
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Nora JAMALI, Nurse; Phone Number: 04 72 11 74 94; Email: nora.jamali@chu-lyon.fr
• Study Contact Backup: Name: Marjolaine Beaudoin, ARC; Phone Number: +33 04 72 11 74 94; Email: marjolaien.beaudoin@chu-lyon.fr

Study Locations

• France
  • Grenoble, France, 38000
    • Recruiting
    • CHU Grenoble
    • Contact: Thomas BATARD, MD
  • Lyon, France, 69003
    • Recruiting
    • Hôpita Edouard Herriot
    • Contact: Nora JAMALI, Nurse

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive indwelling urinary catheter removal; The passive indwelling urinary catheter removal takes place due to gravity.	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 Comparator: Manual indwelling urinary catheter removal; The manual indwelling urinary catheter removal takes place by manual traction by a nurse.	Procedure: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon
• Investigators: Principal Investigator: Camille BENETON, Nurse, Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): July 21, 2022
• Primary Completion (Estimated): March 21, 2027
• Study Completion (Estimated): March 21, 2027

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: March 29, 2022
• First Posted (Actual): April 6, 2022

Study Record Updates

• Last Update Posted (Actual): March 16, 2026
• Last Update Submitted That Met QC Criteria: March 13, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: bladder catheter
• Additional Relevant MeSH Terms: Urogenital Diseases; Male Urogenital Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urologic Diseases
• Other Study ID Numbers: 69HCL21_0171

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No