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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18+
SponsorHospices Civils de Lyon

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male ≥ 18 years old

Endoscopic prostate resection (or transurethral prostate resection).

Laser prostate enucleation

Prostate thermotherapy by radiofrequency

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Passive indwelling urinary catheter removal

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

160 Participants
are divided into 2 treatment groups
Group A: Passive indwelling urinary catheter removalExperimental treatment 1 intervention
Group B: Manual indwelling urinary catheter removalActive comparator 1 intervention

Trial outcomes

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)

Time frame
Within one hour after indwelling urinary catheter removal at day 0

Secondary outcomes

1

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)

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)
2

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)

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)
3

Patient satisfaction

Patient satisfaction will be evaluated using a satisfaction questionnaire without score

Time frame
at Day 0, at Day 2, at Day 15
4

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)

Time frame
at Day 2, at Day 15

Other outcomes

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