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

March 13, 2026 updated by: Hospices Civils de Lyon

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: 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)
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
Time Frame: at Day 0, at Day 2, at Day 15
Patient satisfaction will be evaluated using a satisfaction questionnaire without score
at Day 0, at Day 2, at Day 15
Patient satisfaction
Time Frame: 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)
at Day 2, at Day 15

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospices Civils de Lyon

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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