RElax & feeL at EASE (RELEASE)

Official 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)

Overview

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.

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.

Interventions

• 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.
• 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.

Primary outcome measures

• Change in Intermittent Catheterization Acceptance (I-CAT) Score [Time frame: Baseline (T0) to 3 months (T2)]

Secondary outcome measures (5)

• Adherence to Intermittent Catheterization (I-CAS Score) [Time frame: Baseline (T0) to 3 months (T2)]
• Urinary Symptoms Severity (USQNB-IC) [Time frame: Baseline (T0) to 3 months (T2)]
• Patient Autonomy Level [Time frame: Baseline (T0) to 3 months (T2)]
• Satisfaction with Assistive Technology (QUEST 2.0) [Time frame: 3 months (T2)]
• Overall Functional Abilities [Time frame: Baseline (T0) to 3 months (T2)]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• Vecchio M, Chiaramonte R, DI Benedetto P. Management of bladder dysfunction in multiple sclerosis: a systematic review and meta-analysis of studies regarding bladder rehabilitation. Eur J Phys Rehabil Med. 2022 Jun;58(3):387-396. doi: 10.23736/S1973-9087.22.07217-3. Epub 2022 Feb 1. PMID 35102733
• van der Woude DR, Ruyten T, Bartels B. Reliability of Muscle Strength and Muscle Power Assessments Using Isokinetic Dynamometry in Neuromuscular Diseases: A Systematic Review. Phys Ther. 2022 Oct 6;102(10):pzac099. doi: 10.1093/ptj/pzac099. PMID 35899532
• Tractenberg RE, Groah SL, Rounds AK, Ljungberg IH, Schladen MM. Preliminary validation of a Urinary Symptom Questionnaire for individuals with Neuropathic Bladder using Intermittent Catheterization (USQNB-IC): A patient-centered patient reported outcome. PLoS One. 2018 Jul 10;13(7):e0197568. doi: 10.1371/journal.pone.0197568. eCollection 2018. PMID 29990375
• Tornic J, Panicker JN. The Management of Lower Urinary Tract Dysfunction in Multiple Sclerosis. Curr Neurol Neurosci Rep. 2018 Jun 28;18(8):54. doi: 10.1007/s11910-018-0857-z. PMID 29956001
• Sutton G, Shah S, Hill V. Clean intermittent self-catheterisation for quadriplegic patients--a five year follow-up. Paraplegia. 1991 Oct;29(8):542-9. doi: 10.1038/sc.1991.78. PMID 1775361
• Reuben DB, Magasi S, McCreath HE, Bohannon RW, Wang YC, Bubela DJ, Rymer WZ, Beaumont J, Rine RM, Lai JS, Gershon RC. Motor assessment using the NIH Toolbox. Neurology. 2013 Mar 12;80(11 Suppl 3):S65-75. doi: 10.1212/WNL.0b013e3182872e01. PMID 23479547
• Milligan J, Goetz LL, Kennelly MJ. A Primary Care Provider's Guide to Management of Neurogenic Lower Urinary Tract Dysfunction and Urinary Tract Infection After Spinal Cord Injury. Top Spinal Cord Inj Rehabil. 2020 Spring;26(2):108-115. doi: 10.46292/sci2602-108. PMID 32760189
• Manack A, Motsko SP, Haag-Molkenteller C, Dmochowski RR, Goehring EL Jr, Nguyen-Khoa BA, Jones JK. Epidemiology and healthcare utilization of neurogenic bladder patients in a US claims database. Neurourol Urodyn. 2011 Mar;30(3):395-401. doi: 10.1002/nau.21003. Epub 2010 Sep 29. PMID 20882676

Identifiers

NCT: NCT07084376 · RELEASE

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗