RElax & feeL at EASE (RELEASE)
Launched by STEFANIA MUSCO · Jul 17, 2025
Trial Information
Current as of August 25, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial, called RELEASE, is studying the best way to help men who need to use intermittent catheterization—a method where a small tube is used occasionally to empty the bladder. This is often needed by men with certain bladder problems caused by nerve issues. The study compares two types of training: one is the usual teaching patients get, and the other includes extra educational materials like a booklet and a video along with the standard training. The goal is to see which method helps men feel more comfortable with catheter use, stick to the routine better, and have fewer problems over three months.
Men who are 18 years or older, have a nerve-related bladder condition requiring catheter use, and can manage the catheter on their own are eligible to participate. Participants will be asked to complete some questionnaires and follow the catheter training assigned to them. The study will look at how well they accept and follow the catheter routine, how their symptoms change, and how satisfied they are with the support they receive. This research aims to find the best way to support patients in managing their bladder health independently and safely.
Gender
MALE
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.
About Stefania Musco
Stefania Musco is a dedicated clinical researcher specializing in the design and management of clinical trials aimed at advancing medical knowledge and improving patient outcomes. With a strong background in clinical sciences and a commitment to rigorous research standards, Stefania oversees study protocols, coordinates multidisciplinary teams, and ensures compliance with regulatory requirements. Her expertise supports the development of innovative therapies and contributes to evidence-based healthcare solutions.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported