RElax & feeL at EASE (RELEASE)

NCT07084376 | Not Yet Recruiting DMC

• 1 other identifier: RELEASE
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Incontinence; Neurogenic Bladder Dysfunction; Urinary Retention

Keywords

Intermittent catheterization; Self-catheterization; Patient education; Adherence; Acceptance; Male urology

Outcome Measures

Primary Outcomes (1)

• Change in Intermittent Catheterization Acceptance (I-CAT) Score

  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 Outcomes (5)

• Adherence to Intermittent Catheterization (I-CAS Score)

  Baseline (T0) to 3 months (T2)

• Urinary Symptoms Severity (USQNB-IC)

  Baseline (T0) to 3 months (T2)

• Patient Autonomy Level

  Baseline (T0) to 3 months (T2)

• Satisfaction with Assistive Technology (QUEST 2.0)

  3 months (T2)

• Overall Functional Abilities

  Baseline (T0) to 3 months (T2)

Study Arms (2)

Enhanced Educational Program for Intermittent Catheterization

EXPERIMENTAL

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

Standard Education Group

ACTIVE COMPARATOR

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

Interventions

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.

Enhanced Educational Program for Intermittent Catheterization

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.

Standard Education Group

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: Only individuals who identify as male and correspond to the biological sex assigned at birth (male) are eligible to participate in this study.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stefania Musco: lead

Related Publications (14)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Lapides J, Diokno AC, Lowe BS, Kalish MD. Followup on unsterile intermittent self-catheterization. J Urol. 1974 Feb;111(2):184-7. doi: 10.1016/s0022-5347(17)59922-x. No abstract available.

  PMID: 4810761 BACKGROUND

• Guinet-Lacoste A, Charlanes A, Chesnel C, Blouet E, Tan E, Le Breton F, Amarenco G. Intermittent Catheterization Adherence Scale (ICAS): A new tool for the evaluation of patient adherence with clean intermittent self-catheterization. Neurourol Urodyn. 2018 Nov;37(8):2753-2757. doi: 10.1002/nau.23746. Epub 2018 Jun 28.

  PMID: 29953666 BACKGROUND

• Fitzpatrick MA, Solanki P, Wirth M, Weaver FM, Suda KJ, Burns SP, Safdar N, Collins E, Evans CT. Perceptions, experiences, and beliefs regarding urinary tract infections in patients with neurogenic bladder: A qualitative study. PLoS One. 2023 Nov 1;18(11):e0293743. doi: 10.1371/journal.pone.0293743. eCollection 2023.

  PMID: 37910578 BACKGROUND

• Fitzpatrick MA, Solanki P, Wirth M, Weaver FM, Suda KJ, Burns SP, Safdar N, Collins E, Evans CT. Knowledge, perceptions, and beliefs about urinary tract infections in persons with neurogenic bladder and impacts on interventions to promote person-centered care. Spinal Cord. 2024 May;62(5):221-227. doi: 10.1038/s41393-024-00972-z. Epub 2024 Mar 7.

  PMID: 38454065 BACKGROUND

• Blanc BF, Rodriguez-Almagro J, Lorenzo-Garcia C, Alcaraz-Zomeno E, Fernandez-Llorente G, Baixauli-Puig M, Martin-Bermejo MV, Estudillo-Gonzalez F, Ortega-Checa MA, Lluesma-Martinez V, Ferrandez-Franco G, Benito-Santos B, Rodriguez-Diaz M, Torres-Bacete A, Guerrero-Andrades MC, Louis-Lauture MP, Jimenez-Mayorga I, Serrano-Abielar R, Garrido-Mora MA, Barcia-Barrera F, Asensio-Malo G, Morcillo-Marin M, Tendero-Ruiz S, Hernandez-Martinez A. Quality of Life and Autonomy in Patients with Intermittent Bladder Catheterization Trained by Specialized Nurses. J Clin Med. 2021 Aug 30;10(17):3909. doi: 10.3390/jcm10173909.

  PMID: 34501357 BACKGROUND

• Berardi A, Marquez MA, Ottone L, Ruotolo I, Panuccio F, Tofani M, Gonzalez-Bernal J, Galeoto G. Italian translation, cultural adaptation, and validation of the Intermittent Catheterization Acceptance Test (I-CAT). Clin Ter. 2023 Jan-Feb;174(1):8-13. doi: 10.7417/CT.2023.5002.

  PMID: 36655638 BACKGROUND

MeSH Terms

Conditions

Urinary Retention

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Stefania Musco, MD

CONTACT

+39 3476383462; muscos@aou-careggi.toscana.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: This is a multicenter, parallel-group, randomized controlled trial with two arms. Participants are randomized 1:1 to either an enhanced educational intervention group (informational booklet, video, and standard training) or a control group receiving standard training only. The parallel design allows for direct comparison of outcomes between these two educational strategies.

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: July 24, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): September 30, 2026
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share