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NCT Number: NCT07084376

RElax & feeL at EASE (RELEASE)

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.

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Key information

Conditions

Incontinence Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Neurogenic Bladder Dysfunction Urinary Retention Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Enhanced Educational Program for Intermittent Catheterization

Other

Participants in this group receive an enhanced educational program for intermittent catheterization (IC), including an informational booklet, a specifically designed video tutorial, and standard clinical practice training. The program aims to improve psychological acceptance, adherence, and self-efficacy by providing comprehensive and patient-centered educational materials in addition to standard care.

Standard Education Group

Other

Participants in this group will receive standard clinical practice training for intermittent catheterization (IC), as routinely provided in participating healthcare centers. This training focuses on basic procedural skills and practical education necessary to perform IC independently, without additional enhanced educational materials such as booklets or video tutorials.

Primary outcomes

  1. Change in Intermittent Catheterization Acceptance (I-CAT) Score

    Time frame: Baseline (T0) to 3 months (T2)

    Change in psychological acceptance of intermittent catheterization measured using the Intermittent Catheterization Acceptance Test (I-CAT). The I-CAT assesses acceptance attitudes toward IC, including psychological readiness and emotional adaptation. Higher scores indicate greater acceptance.

Secondary outcomes

  1. Adherence to Intermittent Catheterization (I-CAS Score)

    Time frame: Baseline (T0) to 3 months (T2)

    Adherence to intermittent catheterization practices measured by the Intermittent Catheterization Adherence Scale (I-CAS). The scale evaluates the frequency and consistency of IC behaviors. Higher scores indicate greater adherence.

  2. Urinary Symptoms Severity (USQNB-IC)

    Time frame: Baseline (T0) to 3 months (T2)

    Severity of urinary symptoms measured by the Urinary Symptom Questionnaire for Neurogenic Bladder-Intermittent Catheterization (USQNB-IC). This assesses frequency and severity of symptoms related to bladder dysfunction and catheterization.

  3. Patient Autonomy Level

    Time frame: Baseline (T0) to 3 months (T2)

    Self-reported autonomy in performing intermittent catheterization, assessed through specific questions evaluating confidence and independence in IC management.

  4. Satisfaction with Assistive Technology (QUEST 2.0)

    Time frame: 3 months (T2)

    Satisfaction with assistive technology measured using the Quebec User Evaluation of Satisfaction with Assistive Technology (QUEST 2.0). Higher scores reflect greater satisfaction with IC-related aids and support tools.

  5. Overall Functional Abilities

    Time frame: Baseline (T0) to 3 months (T2)

    Changes in overall functional abilities assessed through patient self-reports on mobility, self-care, and daily activities impacted by IC.

Study contacts

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

Stefania Musco, MD

CONTACT

[email protected]

+39 3476383462

Sponsors and collaborators

Lead sponsor

Stefania Musco

Other

Registry information

Official study title

A Multicenter, Parallel-group, Randomized Controlled Trial to Assess the Efficacy of Two Different Educational Approaches on Intermittent Catheter-related Acceptance and Patient-Reported Outcome Measures (PROMs): RElax & feeL at EASE (RELEASE)

Acronym: RELEASE

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 24, 2025
Registry last updated
Jul 24, 2025

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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