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NCT Number: NCT05313945

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

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.

Recruiting

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Key information

Conditions

Urologic Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Grenoble, Grenoble, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive indwelling urinary catheter removal

Procedure

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 indwelling catheter removal by a nurse

Procedure

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 outcomes

  1. 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)

Secondary outcomes

  1. 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)

  2. 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)

  3. Patient satisfaction

    Time frame: at Day 0, at Day 2, at Day 15

    Patient satisfaction will be evaluated using a satisfaction questionnaire without score

  4. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Marjolaine Beaudoin, ARC

CONTACT

[email protected]

04 72 11 74 94 ext. +33

Nora JAMALI, Nurse

CONTACT

[email protected]

04 72 11 74 94

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: IDESONDE

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Apr 6, 2022
Registry last updated
Mar 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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