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
1 other identifier
interventional
160
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2022
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 29, 2022
CompletedFirst Posted
Study publicly available on registry
April 6, 2022
CompletedStudy Start
First participant enrolled
July 21, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 21, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 21, 2027
March 16, 2026
March 1, 2026
4.7 years
March 29, 2022
March 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
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 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)
Patient satisfaction
at Day 0, at Day 2, at Day 15
Patient satisfaction
at Day 2, at Day 15
Study Arms (2)
Passive indwelling urinary catheter removal
EXPERIMENTALThe passive indwelling urinary catheter removal takes place due to gravity.
Manual indwelling urinary catheter removal
ACTIVE COMPARATORThe manual indwelling urinary catheter removal takes place by manual traction by a nurse.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
CHU Grenoble
Grenoble, 38000, France
Hôpita Edouard Herriot
Lyon, 69003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Camille BENETON, Nurse
Hospices Civils de Lyon
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2022
First Posted
April 6, 2022
Study Start
July 21, 2022
Primary Completion (Estimated)
March 21, 2027
Study Completion (Estimated)
March 21, 2027
Last Updated
March 16, 2026
Record last verified: 2026-03