RElax & feeL at EASE (RELEASE)

Stefania Musco

Status: Not yet enrolling

Conditions: Urinary Retention; Neurogenic Bladder Dysfunction; Incontinence

Treatments: Other: Enhanced Educational Program for Intermittent Catheterization; Other: Standard Education Group

Study type: Interventional

Funder types: Other

Identifiers

NCT07084376

RELEASE

Details and patient eligibility

About

This multicenter, parallel-group, randomized controlled trial (RELEASE) aims to evaluate the efficacy of two educational approaches on acceptance and adherence to intermittent catheterization (IC) among adult male patients. Participants requiring IC training will be randomized to either an enhanced educational intervention (informational booklet, video tutorial, and standard training) or standard clinical practice training alone. The primary outcome is the change in Intermittent Catheterization Acceptance Test (I-CAT) scores over three months. Secondary outcomes include adherence (I-CAS), urinary symptoms (USQNB-IC), patient autonomy, satisfaction with assistive technology (QUEST), and functional abilities. The study seeks to identify the most effective educational strategy to improve psychological acceptance, promote adherence, and reduce complications in patients performing IC, ultimately supporting patient-centered care and health system efficiency.

Full description

This multicenter, randomized controlled trial (RELEASE study) investigates the effectiveness of two different educational approaches to improve acceptance and adherence to intermittent catheterization (IC) among adult male patients who require IC training. Participants will be randomly assigned to one of two groups: an intervention group receiving an enhanced educational program (including an informational booklet, video tutorial, and standard clinical training) and a control group receiving only standard clinical practice training.

The study will enroll adult male patients with an indication for self-managed intermittent catheterization and who are physically and cognitively able to learn IC techniques. The primary outcome measure is the change in Intermittent Catheterization Acceptance Test (I-CAT) scores at three months (T2) compared to baseline (T0).

Secondary outcomes include adherence measured using the Intermittent Catheterization Adherence Scale (I-CAS), urinary symptoms evaluated with the USQNB-IC, patient autonomy, satisfaction with assistive technology (QUEST 2.0), and overall functional abilities. Additional data such as socio-demographic characteristics and medical history will also be collected.

The trial seeks to provide evidence on the most effective educational strategy to support psychological acceptance and sustained adherence to IC, reduce complications, and promote greater patient autonomy. By addressing educational gaps, the study aims to enhance patient-centered care and optimize resource use within the healthcare system.

Enrollment: 64 estimated patients

Sex: Male

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male patients aged 18 years or older.
• Diagnosed with neurogenic bladder requiring self-managed intermittent catheterization (IC).
• Currently performing IC or newly prescribed IC.
• Able to provide informed consent and understand study instructions.
• Able to understand and complete study questionnaires in Italian.

Exclusion criteria

• Presence of cognitive impairment limiting ability to understand or perform IC independently.
• Severe upper limb motor deficits preventing independent catheterization.
• Active urinary tract infection at baseline.
• Participation in another interventional study that could interfere with outcomes.
• Any condition that, in the opinion of the investigators, makes the patient unsuitable for study participation.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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64 participants in 2 patient groups

Enhanced Educational Program for Intermittent Catheterization

Experimental group

Description:

Participants in this arm will receive an enhanced educational intervention comprising an informational booklet, a video tutorial specifically designed for self-managed intermittent catheterization (IC), and standard clinical practice training. This comprehensive approach aims to improve psychological acceptance, adherence, and self-efficacy in performing IC

Treatment:

Other: Enhanced Educational Program for Intermittent Catheterization

Standard Education Group

Active Comparator group

Description:

Participants receive standard clinical practice training for self-managed intermittent catheterization (IC) as typically provided in routine care settings. This arm serves as the active comparator to evaluate the additional impact of the enhanced educational intervention.

Treatment:

Other: Standard Education Group