RElax & feeL at EASE (RELEASE) (RELEASE)

July 17, 2025 updated by: Stefania Musco

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)

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

64

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enhanced Educational Program for Intermittent Catheterization
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
Other: Enhanced Educational Program for Intermittent Catheterization
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.
Active Comparator: Standard Education Group
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.
Other: Standard Education Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0) to 3 months (T2)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline (T0) to 3 months (T2)
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.
Baseline (T0) to 3 months (T2)
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.
Baseline (T0) to 3 months (T2)
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.
3 months (T2)
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.
Baseline (T0) to 3 months (T2)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stefania Musco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2025

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

September 30, 2026

Study Registration Dates

First Submitted

July 17, 2025

First Submitted That Met QC Criteria

July 17, 2025

First Posted (Actual)

July 24, 2025

Study Record Updates

Last Update Posted (Actual)

July 24, 2025

Last Update Submitted That Met QC Criteria

July 17, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RELEASE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Given the nature of your intervention (behavioral educational intervention on intermittent catheterization) and local privacy considerations, individual participant data (IPD) will not be shared publicly.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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