Evaluation of Quality-of-Life Improvements Using UroShield Device

Status Recruiting

Clinical Trial Summary

The goal of this pilot study is to test key elements of the full study that will follow, including recruitment and retention strategies, intervention delivery, laboratory testing, data collection methods, and adherence to study protocol. The main questions the investigators aim to answer focus on implementation and practicality: - Recruitment feasibility and time to recruit - How well do participants adhere to device protocol? - How often do device components (i.e., actuators and drivers) have to be replaced? - How much time is required for data collection and what sources or methods for data collection are used? Results of this pilot study will inform the investigators as to necessary protocol modifications and overall feasibility for the larger randomized clinical trial to follow.

Clinical Trial Description

The UroShield® device works by generating ultrasonic waves to interfere with attachment of bacteria inside the catheter, preventing biofilm formation and subsequent infections. This double-blind pilot study aims to recruit 10-20 patients with urinary catheters (urethral or suprapubic catheters) living in nursing homes (NHs) in Michigan. Patients who consent to participate in the study will be randomized to either the treatment or control group and will have either an active treatment UroShield® device attached or a sham UroShield® device attached to the external tubing of their urinary catheter. Participants will wear the device continuously for a maximum of 90 days. Assessments of pain and quality-of-life will be conducted by study staff over a maximum of 6 study visits, along with clinical data collection via medical record review. A urine sample and catheter sample will also be collected by study staff at each catheter change (approximately every 30 days). ;

Study Design

Related Conditions & MeSH terms

Catheter-Associated Urinary Tract Infection
Quality of Life
Urinary Tract Infections

Clinical Trial Details

NCT number	NCT06319352
Study type	Interventional
Source	University of Michigan
Contact	Lona Mody
Phone	7347648942
Email	lonamody@med.umich.edu
Status	Recruiting
Phase	N/A
Start date	April 29, 2024
Completion date	October 2024

View Details

See also
Status	Clinical Trial	Phase
Active, not recruiting	`NCT05559255` - Changes in Pain, Spasticity, and Quality of Life After Use of Counterstrain Treatment in Individuals With SCI	N/A
Completed	`NCT06238557` - Prospective Evaluation of Psychological Consequences and Impact on Long-term Quality of Life
Recruiting	`NCT05563805` - Exploring Virtual Reality Adventure Training Exergaming	N/A
Completed	`NCT05472935` - Asynchronous Mindfulness Based Stress Reduction to Reduce Burnout in Licensed Clinical Social Workers	N/A
Recruiting	`NCT04444544` - Quality of Life and High-Risk Abdominal Cancer Surgery
Completed	`NCT04281953` - Impact on Quality of Life of Long-term Ototoxicity in Cancer Survivors
Recruiting	`NCT05546931` - Mobile Health Program for Rural Hypertension	N/A
Active, not recruiting	`NCT04746664` - Effects of Nutrition Counselling on Old Age People's Nutritional Status and Quality of Life in Bahir Dar City, North West Ethiopia	N/A
Completed	`NCT05387174` - Nursing Intervention in Two Risk Factors of the Metabolic Syndrome and Quality of Life in the Climacteric Period	N/A
Recruiting	`NCT04142827` - The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX)	N/A
Active, not recruiting	`NCT05903638` - A Pilot RCT: the Impact of a Virtual MBSR Course on Women With Primary Infertility	N/A
Completed	`NCT05538455` - Investigating ProCare4Life Impact on Quality of Life of Elderly Subjects With Neurodegenerative Diseases	N/A
Completed	`NCT06216015` - Exercise Training and Kidney Transplantation	N/A
Completed	`NCT03813420` - Sleep Quality of Physiotherapy Students Quality of Life and Physical Activity Level	N/A
Recruiting	`NCT05550545` - Infant RSV Infections and Health-related Quality of Life of Families
Completed	`NCT05346588` - THRIVE Feasibility Trial	Phase 3
Recruiting	`NCT05233020` - Robotic Versus Hybrid Assisted Ventral Hernia Repair	N/A
Terminated	`NCT03304184` - The Role of Biodentine in Class V Dental Lesions on Oral Health Related Quality of Life	Phase 3
Completed	`NCT05063305` - Probiotics, Immunity, Stress, and QofL	N/A
Recruiting	`NCT05380856` - Sacral Neuromodulation for Neurogenic Lower Urinary Tract, Bowel and Sexual Dysfunction	N/A