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

Primary Purpose

Urologic Diseases

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Passive indwelling urinary catheter removal
Active indwelling catheter removal by a nurse
Sponsored by
Hospices Civils de Lyon
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Urologic Diseases focused on measuring bladder catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CHU GrenobleRecruiting
  • Hôpita Edouard Herriot

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Passive indwelling urinary catheter removal

Manual indwelling urinary catheter removal

Arm Description

The passive indwelling urinary catheter removal takes place due to gravity.

The manual indwelling urinary catheter removal takes place by manual traction by a nurse.

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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)
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)
Patient satisfaction
Patient satisfaction will be evaluated using a satisfaction questionnaire without score
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)

Full Information

First Posted
March 29, 2022
Last Updated
August 9, 2023
Sponsor
Hospices Civils de Lyon
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1. Study Identification

Unique Protocol Identification Number
NCT05313945
Brief Title
Evaluation Patient Satisfaction After Passive Bladder Catheter Removal Compared to Active Removal
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 21, 2022 (Actual)
Primary Completion Date
August 5, 2024 (Anticipated)
Study Completion Date
August 5, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urologic Diseases
Keywords
bladder catheter

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Passive indwelling urinary catheter removal
Arm Type
Experimental
Arm Description
The passive indwelling urinary catheter removal takes place due to gravity.
Arm Title
Manual indwelling urinary catheter removal
Arm Type
Active Comparator
Arm Description
The manual indwelling urinary catheter removal takes place by manual traction by a nurse.
Intervention Type
Procedure
Intervention Name(s)
Passive indwelling urinary catheter removal
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Active indwelling catheter removal by a nurse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient satisfaction score
Description
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)
Time Frame
Within one hour after indwelling urinary catheter removal at day 0
Secondary Outcome Measure Information:
Title
The pain experienced by patients
Description
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)
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)
Title
The anxiety experienced by patients
Description
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)
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)
Title
Patient satisfaction
Description
Patient satisfaction will be evaluated using a satisfaction questionnaire without score
Time Frame
at Day 0, at Day 2, at Day 15
Title
Patient satisfaction
Description
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)
Time Frame
at Day 2, at Day 15

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Camille BENETON, Nurse
Phone
0472119111
Ext
+33
Email
camille.beneton@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Vasiliki VELOUDOU, Nurse
Phone
0472119622
Ext
+33
Email
vasiliki.veloudou@chu-lyon.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Camille BENETON, Nurse
Organizational Affiliation
Hospices Civils de Lyon
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Grenoble
City
Grenoble
ZIP/Postal Code
38000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LONG ALEXANDRE, MD
Facility Name
Hôpita Edouard Herriot
City
Lyon
ZIP/Postal Code
69003
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beneton Camille, Nurse

12. IPD Sharing Statement

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

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