NCT07641101

Brief Summary

This is a single-blind randomized controlled trial for patients with neurogenic bladder after incomplete spinal cord injury. Participants are randomly divided into two groups. The control group receives routine transitional nursing and telephone follow-up, while the intervention group gets 4-week app-supported transitional care including health education, bladder recording and online consultation. After intervention, bladder residual urine, urinary tract infection rate, self-care ability and quality of life are compared between two groups.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 6, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 11, 2026

Completed
Last Updated

June 11, 2026

Status Verified

June 1, 2026

Enrollment Period

4 months

First QC Date

June 6, 2026

Last Update Submit

June 10, 2026

Conditions

Keywords

Transitional Care, Mobile Application, Quality of Life, Randomized Controlled Trial, Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

  • Incidence of urinary tract infection

    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

    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 Outcomes (1)

  • Self-care ability and quality of life score

    Baseline and 4 weeks after intervention

Study Arms (2)

Control Group

ACTIVE COMPARATOR

Patients receive routine standardized inpatient bladder nursing, only one-time routine telephone follow-up after discharge without APP-based transitional care intervention

Other: routine standardized inpatient bladder nursing

Intervention Group

EXPERIMENTAL

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.

Behavioral: Mobile Application Based Transitional CareOther: routine standardized inpatient bladder nursing

Interventions

routine standardized inpatient bladder nursing

Control GroupIntervention Group

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.

Intervention Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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. -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Siping Central People's Hospital

Siping, Jilin, 136000, China

Location

MeSH Terms

Conditions

Urinary Bladder, NeurogenicSpinal Cord Injuries

Condition Hierarchy (Ancestors)

Neurologic ManifestationsNervous System DiseasesUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal Cord DiseasesCentral Nervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate Student, School of Nursing, Xiamen University

Study Record Dates

First Submitted

June 6, 2026

First Posted

June 11, 2026

Study Start

January 10, 2026

Primary Completion

May 1, 2026

Study Completion

May 1, 2026

Last Updated

June 11, 2026

Record last verified: 2026-06

Data Sharing

IPD Sharing
Will not share

Individual participant raw data will not be shared publicly due to patient privacy protection and relevant hospital data management regulations.

Locations