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

NCT ID: NCT05313945

Last Updated: 2025-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-21

Study Completion Date

2026-03-21

Brief Summary

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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.

Detailed Description

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Conditions

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Urologic Diseases

Keywords

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bladder catheter

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Passive indwelling urinary catheter removal

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

Group Type EXPERIMENTAL

Passive indwelling urinary catheter removal

Intervention Type 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.

Manual indwelling urinary catheter removal

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

Group Type ACTIVE_COMPARATOR

Active indwelling catheter removal by a nurse

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Hospices Civils de Lyon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Camille BENETON, Nurse

Role: PRINCIPAL_INVESTIGATOR

Hospices Civils de Lyon

Locations

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CHU Grenoble

Grenoble, , France

Site Status RECRUITING

Hôpita Edouard Herriot

Lyon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Nora JAMALI, Nurse

Role: CONTACT

Phone: 04 72 11 74 94

Email: [email protected]

Marjolaine Beaudoin, ARC

Role: CONTACT

Phone: 04 72 11 74 94

Email: [email protected]

Facility Contacts

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Thomas BATARD, MD

Role: primary

Nora JAMALI, Nurse

Role: primary

Other Identifiers

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69HCL21_0171

Identifier Type: -

Identifier Source: org_study_id