- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07641101
Effects Of App-Supported Transitional Care On Neurogenic Bladder In Spinal Cord Injury Patients
Effects Of App-Supported Transitional Care On Bladder Function And Quality Of Life in Patients With Neurogenic Bladder After Incomplete Spinal Cord Injury: A Randomised Controlled Trial
Study Overview
Status
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Jilin
-
Siping, Jilin, China, 136000
- Siping Central People's Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Diagnosed with neurogenic bladder secondary to incomplete spinal cord injury; Age ranging from 18 to 75 years old; Clear consciousness, capable of cooperating with nursing assessment and mobile APP follow-up management; Voluntarily sign written informed consent. -
Exclusion Criteria:
Combined with severe renal insufficiency, malignant tumor or other life-threatening severe systemic diseases; History of previous bladder reconstructive surgery; Cognitive impairment unable to independently operate mobile APP; Refuse to continue follow-up or withdraw voluntarily during the research period.
-
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Control Group
Patients receive routine standardized inpatient bladder nursing, only one-time routine telephone follow-up after discharge without APP-based transitional care intervention
|
routine standardized inpatient bladder nursing
|
|
Experimental: Intervention Group
Same routine inpatient nursing as control group plus 4 weeks of systematic APP-supported transitional care including health education, voiding record management and online nurse consultation.
|
routine standardized inpatient bladder nursing
Four-week continuous transitional nursing service via mobile APP for patients with neurogenic bladder after incomplete spinal cord injury, including disease-related health education, real-time voiding record, regular nursing reminder and online one-on-one nurse consultation, which differs from routine single telephone follow-up in control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of urinary tract infection
Time Frame: Within 4 weeks after subject enrollment
|
Count the occurrence of urinary tract infection within 4-week follow-up and calculate infection incidence of each group.
|
Within 4 weeks after subject enrollment
|
|
Post-void residual urine volume
Time Frame: Baseline and 4 weeks after intervention
|
Bladder residual urine volume is measured by ultrasonic examination at baseline and after 4 weeks of nursing intervention to compare the difference between two groups.
|
Baseline and 4 weeks after intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Self-care ability and quality of life score
Time Frame: Baseline and 4 weeks after intervention
|
Standardized scale scoring for self-care and quality of life before and after 4-week transitional nursing.
|
Baseline and 4 weeks after intervention
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Neurologic Manifestations
- Central Nervous System Diseases
- Nervous System Diseases
- Wounds and Injuries
- Male Urogenital Diseases
- Urologic Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Trauma, Nervous System
- Urinary Bladder Diseases
- Spinal Cord Diseases
- Pathological Conditions, Signs and Symptoms
- Signs and Symptoms
- Spinal Cord Injuries
- Urinary Bladder, Neurogenic
Other Study ID Numbers
- SKYLW-2024-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Neurogenic Bladder, Incomplete Spinal Cord Injury
-
Baylor College of MedicineU.S. Department of EducationTerminatedSpinal Cord Injury | Neurogenic Bladder Dysfunction NosUnited States
-
Fundació Sant Joan de DéuHospital San Juan de Dios, SpainNot yet recruitingIncomplete Spinal Cord Injury (SCI)Spain
-
Poznan University of Medical SciencesUnknownSpinal Cord Injuries | Neurogenic Bladder | UrodynamicsPoland
-
University of ZurichSwiss National Science Foundation; Swiss Paraplegic Research, NottwilRecruitingSpinal Cord Injuries | Neurogenic Bladder Dysfunction | Degenerative Cervical Spinal StenosisSwitzerland
-
The University of Texas Health Science Center,...CompletedNeurogenic Bowel | Chronic Spinal Cord InjuryUnited States
-
The University of Texas Health Science Center at...CompletedCognitive Change | Spinal Cord Injuries | Neurogenic BladderUnited States
-
Centre Hospitalier Universitaire de NīmesRecruitingSpinal Cord Injuries | Neurogenic Bladder | Urinary DiversionFrance
-
The University of Texas Health Science Center,...Baylor College of Medicine; University of Houston; Case Western Reserve University and other collaboratorsCompletedSpinal Cord Injury | Neurogenic BladderUnited States
-
University Hospital, BordeauxMinistry of Health, FranceCompletedSpinal Cord Injuries | Quadriplegia | Paraplegia | Neurogenic Bladder DisorderFrance
-
TengionTerminatedNeurogenic BladderUnited States
Clinical Trials on routine standardized inpatient bladder nursing
-
Regional Medical Center of San JoseUnknown
-
Ruhr University of BochumStillachhaus PrivatklinikCompleted
-
Mehtap GümüşayCompletedQuality of Life | Nursing Caries | Surgical MenopauseTurkey
-
National Taiwan University Hospital Hsin-Chu BranchTerminatedAnxiety | Nursing Education | Augmented Reality | ImmersiveTaiwan
-
National Defense Medical Center, TaiwanRecruitingBreast Cancer Early Stage Breast Cancer (Stage 1-3)Taiwan
-
Children's Hospital of Eastern OntarioCHAMO Innovation FundCompleted
-
Shanxi Province Cancer HospitalCompletedLung Neoplasms | Small Cell Lung Cancer | Extensive-Stage Small Cell Lung CancerChina
-
The First Hospital of Hebei Medical UniversityCompletedLung Neoplasms | AnxietyChina
-
Shanxi Province Cancer HospitalCompletedCancer-related Fatigue | Advanced Lung CancerChina
-
First Affiliated Hospital Xi'an Jiaotong UniversityCompleted