IncontinenceRELEASENCT07084376
RElax & feeL at EASE (RELEASE)
A study testing Enhanced Educational Program for Intermittent Catheterization and Standard Education Group in people with Incontinence and Neurogenic Bladder Dysfunction, run by Stefania Musco.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Incontinence, Neurogenic Bladder Dysfunction, Urinary Retention
- What is being tested?
- Enhanced Educational Program for Intermittent Catheterization and Standard Education Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Sep 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the 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.
- Being tested
- Enhanced Educational Program for Intermittent Catheterization, Standard Education Group
- Keywords
- Intermittent catheterization, Self-catheterization, Patient education, Adherence, Acceptance, Male urology
- Medical subject headings
- Urinary Retention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Educational Program for Intermittent CatheterizationOther
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 GroupOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Standard Education Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (T0) to 3 months (T2)
Secondary outcomes (5)
Adherence to Intermittent Catheterization (I-CAS Score)
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.
Measured: Baseline (T0) to 3 months (T2)
Urinary Symptoms Severity (USQNB-IC)
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.
Measured: Baseline (T0) to 3 months (T2)
Patient Autonomy Level
Self-reported autonomy in performing intermittent catheterization, assessed through specific questions evaluating confidence and independence in IC management.
Measured: Baseline (T0) to 3 months (T2)
Satisfaction with Assistive Technology (QUEST 2.0)
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.
Measured: 3 months (T2)
Overall Functional Abilities
Changes in overall functional abilities assessed through patient self-reports on mobility, self-care, and daily activities impacted by IC.
Measured: Baseline (T0) to 3 months (T2)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for IncontinenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 64 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stefania Musco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Stefania Musco, Careggi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084376
- Sponsor's protocol ID
- RELEASE
- Acronym
- RELEASE
- Status last verified
- Jul 2025
- First submitted
- 17 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
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.
PubMed 35102733van 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.
PubMed 35899532Tractenberg 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.
PubMed 29990375Tornic 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.
PubMed 29956001Sutton 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.
PubMed 1775361Reuben 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.
PubMed 23479547Milligan 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.
PubMed 32760189Manack 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.
PubMed 20882676Lapides 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.
PubMed 4810761Guinet-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.
PubMed 29953666Fitzpatrick 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.
PubMed 37910578Fitzpatrick 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.
PubMed 38454065Blanc 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.
PubMed 34501357Berardi 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.
PubMed 36655638